Tablets comprising bempedoic acid or bempedoic acid and ezetimibe

Abstract

The present invention relates to tablets comprising bempedoic acid, tablets comprising bempedoic acid and ezetimibe and processes for preparation thereof. Furthermore, the present invention relates to granules comprising bempedoic acid, granules comprising bempedoic acid and ezetimibe, tablets comprising such granules and processes for preparation of such granules.

Description

[0001] Tablets comprising bempedoic acid or bempedoic acid and ezetimibe

[0002] Field of the invention

[0003] The present invention relates to tablets comprising bempedoic acid, tablets comprising bempedoic acid and ezetimibe and processes for preparation thereof. Furthermore, the present invention relates to granules comprising bempedoic acid, granules comprising bempedoic acid and ezetimibe, tablets comprising such granules and processes for preparing such granules.

[0004] Background of the invention

[0005] Bempedoic acid, chemical name 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid, was first disclosed in WO 2004 / 067489 Al. It is a dual acting AMP -activated protein kinase (AMPK) activator and ATP citrate lyase (ACL) inhibitor.

[0006] Bempedoic acid polymorph form was described first in IPCOM000254434D. Furthermore bempedoic polymorph forms, bempedoic acid salts and their polymorph forms and processes for preparing bempedoic acid are described in EP 3666750 Al, WO 2020 / 141419 Al, CN 111559961 A, WO 2020 / 257571 Al, WO 2020 / 257573 Al, WO 2021 / 064166A and WO 2021 / 110929A.

[0007] A product comprising bempedoic acid is approved in the form of film-coated tablets and marketed under the brand name Nilemdo®, and it is indicated for the treatment of hypercholesterolaemia and mixed dyslipidaemia and the prevention and treatment of cardiovascular diseases. Nilemdo ® film- coated tablets contain 180 mg of bempedoic acid.

[0008] Furthermore, a product comprising bempedoic acid and ezetimibe is approved in the form of film- coated tablets and marketed under the brand name Nustendi® and it is indicated for the treatment of hypercholesterolaemia and mixed dyslipidaemia and the prevention and treatment of cardiovascular diseases. Nustendi® film-coated tablets contain 180 mg of bempedoic acid and 10 mg of ezetimibe.

[0009] Ezetimibe, chemical name l-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]4(S)-(4- hydroxyphenyl)-2-azetidinone is a potent cholesterol absorption inhibitor.

[0010] Nilemdo® tablets comprise bempedoic acid granules, and Nustendi ® tablets comprise separate bempedoic acid granules and ezetimibe granules. Bempedoic acid granules of both products comprise a lubricant silicon dioxide. Nilemdo® tablets and Nustendi ® tablets are described in WO 2018 / 218147 Al.

[0011] In addition, WO 2018 / 218147 Al describes bempedoic acid granules free of lubricant. However, such granules were difficult to prepare due to sticking behavior. Further bempedoic acid granules are described in IN 202011045799, IN 202121033685, WO 2023 / 036980 Al, IN 202141043941, WO2023217694.

[0012] Furthermore, tablets comprising bempedoic acid and ezetimibe are described in IN 202141043941, wherein tablets comprise granules comprising both active ingredients together.IN 202111003944 describes tablets comprising bempedoic acid or bempedoic acid and ezetimibe in combination with statins, wherein tablets comprise separate bempedoic acid granules, ezetimibe granules and statin granules or tablets comprise granules comprising all three active ingredients together.

[0013] There is a need for alternative and improved tablets comprising bempedoic acid or bempedoic acid and ezetimibe, particularly for tablets that can be manufactured by simpler and less time-consuming process.

[0014] In addition, there is a need for alternative and improved granules comprising bempedoic acid or bempedoic acid and ezetimibe, that can be used in mono product or combination products.

[0015] Summary of the invention

[0016] The present invention comprises in particular the following items:

[0017] (1) A tablet, in particular a tablet comprising a tablet core and optionally a coating, the tablet comprising bempedoic acid granules (also designated “granules comprising bempedoic acid” herein, see below), and ezetimibe in an extragranular phase.

[0018] (2) The tablet according to item (1), wherein the tablet comprises or consists of: a) the granules comprising bempedoic acid, b) the extragranular phase comprising: bl) ezetimibe, b2) an extragranular diluent, b3) an extragranular disintegrant, b4) optionally, an extragranular solubilizing agent, b5) optionally, an extragranular glidant, b6) optionally, an extragranular lubricant.

[0019] (3) The tablet according to item (1) or item (2), wherein the tablet comprises or consists of: a) the granules comprising bempedoic acid, comprising: al) bempedoic acid, a2) an intragranular diluent, a3) an intragranular binder, a4) optionally, an intragranular disintegrant, a5) optionally, an intragranular glidant, a6) optionally, an intragranular lubricant, b) the extragranular phase comprising: bl) ezetimibe, b2) an extragranular diluent, b3) an extragranular disintegrant, b4) optionally, an extragranular solubilizing agent, b5) optionally, an extragranular glidant, b6) optionally, an extragranular lubricant.

[0020] (4) The tablet according to any one of items (1) to (3), wherein the tablet comprises or consists of: a) the granules comprising bempedoic acid, consisting of: al) bempedoic acid, a2) an intragranular diluent, a3) an intragranular binder, a4) optionally, an intragranular disintegrant, b) the extragranular phase comprising: bl) ezetimibe, b2) an extragranular diluent, b3) an extragranular disintegrant, b4) optionally, an extragranular solubilizing agent, b5) optionally, an extragranular glidant, b6) optionally, an extragranular lubricant.

[0021] (5) The tablet according to any one of items (1) to (4), wherein the tablet comprises a tablet core and optionally a coating, wherein the tablet comprises or consists of: a) 45-70 wt.% of the granules comprising bempedoic acid, preferably 50-70 wt.% of the granules comprising bempedoic acid, more preferably 55-65 wt.% of the granules comprising bempedoic acid relative to the total weight of the tablet core, b) 30-55 wt.% of the extragranular phase, preferably 30-50 wt.% of the extragranular phase, more preferably 35-45 wt.% of the extragranular phase relative to the total weight of the tablet core.

[0022] (6) A tablet comprising granules, wherein granules comprise bempedoic acid and ezetimibe.

[0023] (7) The tablet according to item (6), wherein the tablet comprises or consists of: a) the granules comprising: al) bempedoic acid, a2) ezetimibe, a3) an intragranular diluent, a4) an intragranular binder, a5) optionally, an intragranular disintegrant, a6) optionally, an intragranular solubilizing agent, a7) optionally, an intragranular glidant, a8) optionally, an intragranular lubricant, b) an extragranular phase comprising: bl) an extragranular diluent, b2) an extragranular disintegrant, b3) optionally, an extragranular solubilizing agent, b4) optionally, an extragranular glidant, b5) optionally, an extragranular lubricant.

[0024] (8) The tablet according to item (6) or item (7), wherein the tablet comprises or consists of: a) the granules consisting of: al) bempedoic acid, a2) ezetimibe a3) an intragranular diluent, a4) an intragranular binder, a5) optionally, an intragranular disintegrant, a6) optionally, an intragranular solubilizing agent, b) an extragranular phase comprising: bl) an extragranular diluent, b2) an extragranular disintegrant, b3) optionally, an extragranular solubilizing agent, b4) optionally, an extragranular glidant, b5) optionally, an extragranular lubricant.

[0025] (9) The tablet according to any one of items (1) to (8), wherein the intragranular diluent is selected from microcrystalline cellulose, mannitol, lactose, lactose monohydrate, lactose anhydrous, sorbitol, starch, sucrose, calcium carbonate, calcium phosphate, calcium sulfate, erythritol, fructose, inulin, isomalt, lactitol, magnesium carbonate, magnesium oxide, maltitol, maltodextrin, maltose, polydextrose, sodium bicarbonate, sodium carbonate, sodium chloride, trehalose, xylitol, cellulose acetate, or a mixture thereof, preferably the intragranular diluent is microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol or starch, more preferably microcrystalline cellulose, lactose, or a mixture thereof, even more preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, even more preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, most preferably microcrystalline cellulose.

[0026] (10) The tablet according to any one of items (1) to (9), wherein the intragranular binder is selected from hydroxypropyl cellulose, hydroxypropylmethyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, ethyl cellulose, cellulose acetate phthalate, povidone, acacia, agar, alginic acid, calcium carbonate, carboxymethylcellulose sodium, chitosan, crosslinked polyvinylpyrrolidone, com syrup solids, dextrates, dextrin, dextrose, gelatin, guar gum, isomalt, maltitol, maltodextrin, maltose, poloxamer, polydextrose, polyethylene oxide, polymethacrylates, polyvinyl alcohol, sodium alginate, starch, pregelatinized starch or sucrose, preferably the intragranular binder is hydroxypropyl cellulose, povidone, hydroxypropylmethyl cellulose or crosslinked polyvinylpyrrolidone, more preferably hydroxypropyl cellulose or povidone, most preferably hydroxypropyl cellulose.

[0027] (11) The tablet according to any one of items (1) to (10), wherein the intragranular disintegrant is selected from sodium starch glycolate, croscarmellose sodium, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone, carboxymethylcellulose calcium, pregelatinized starch, alginic acid, calcium alginate, chitosan, carboxymethylcellulose calcium, guar gum, magnesium aluminium silicate, methylcellulose, povidone, sodium alginate or starch, preferably the intragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium, sodium starch glycolate or low- substituted hydroxypropyl cellulose, more preferably sodium starch glycolate.

[0028] (12) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (11), wherein the intragranular glidant is selected from silicon dioxide, colloidal silicon dioxide, anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide, hydrophobic colloidal silicon dioxide, talc, magnesium silicate, magnesium trisilicate, tribasic calcium phosphate, powdered cellulose, magnesium oxide, sodium stearate or sodium stearyl fumarate, preferably the intragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, more preferably colloidal silicon dioxide, even more preferably anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide or hydrophobic colloidal silicon dioxide, most preferably anhydrous colloidal silicon dioxide. (13) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (11), wherein the intragranular lubricant is selected from magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl monostearate, glyceryl palmitostearate, glyceryl dibehenate, glyceryl behenate, leucine, myristic acid, palmitic acid, poloxamer, polyethylene glycol, potassium benzoate, sodium benzoate, sodium stearate, stearic acid, talc, tribehenin or zinc stearate, preferably the intragranular lubricant is magnesium stearate, sodium stearyl fumarate or talc, more preferably magnesium stearate.

[0029] (14) The tablet according to any one of items (1) to (13), wherein the extragranular diluent is selected from microcrystalline cellulose, mannitol, lactose, lactose monohydrate, lactose anhydrous, sorbitol, starch, sucrose, calcium carbonate, calcium phosphate, calcium sulfate, erythritol, fructose, inulin, isomalt, lactitol, magnesium carbonate, magnesium oxide, maltitol, maltodextrin, maltose, polydextrose, sodium bicarbonate, sodium carbonate, sodium chloride, trehalose, xylitol, cellulose acetate, or a mixture thereof, preferably the extragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, more preferably microcrystalline cellulose, lactose or a mixture thereof, even more preferably a mixture of microcrystalline cellulose and lactose, most preferably a mixture of microcrystalline cellulose and lactose monohydrate.

[0030] (15) The tablet according to any one of items (1) to (14), wherein the extragranular disintegrant is selected from sodium starch glycolate, croscarmellose sodium, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone, carboxymethylcellulose calcium, pregelatinized starch, alginic acid, calcium alginate, chitosan, carboxymethylcellulose calcium, guar gum, magnesium aluminium silicate, methylcellulose, povidone, sodium alginate or starch, preferably the extragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium, sodium starch glycolate or low- substituted hydroxypropyl cellulose, more preferably sodium starch glycolate.

[0031] (16) The tablet according to any one of items (1) to (15), wherein the extragranular solubilizing agent or the intragranular solubilizing agent is selected from sodium lauryl sulfate, benzyl benzoate, benzalkonium chloride, betadex sulfobutyl ether sodium, cetylpyridinium chloride, cyclodextrins, diethylene glycol monoethyl ether, fumaric acid, hydroxypropyl betadex, hypromellose, lanolin alcohols, lecithin, oleic acid, oleyl alcohol, phospholipids, poloxamer, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyoxyl 15 hydroxystearate, poly oxy Iglycerides, sorbitan esters, sorbitan fatty acid esters, stearic acid, triolein or vitamin E polyethylene glycol succinate, preferably the extragranular solubilizing agent is sodium lauryl sulfate.

[0032] (17) The tablet according to any one of items (1) to (16), wherein the extragranular glidant is selected from silicon dioxide, colloidal silicon dioxide, anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide, hydrophobic colloidal silicon dioxide, talc, magnesium silicate, magnesium trisilicate, tribasic calcium phosphate, powdered cellulose, magnesium oxide, sodium stearate or sodium stearyl fumarate, preferably the extragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, more preferably colloidal silicon dioxide, even more preferably anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide or hydrophobic colloidal silicon dioxide, most preferably anhydrous colloidal silicon dioxide. (18) The tablet according to any one of items (1) to (17), wherein the extragranular lubricant is selected from magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl monostearate, glyceryl palmitostearate, glyceryl dibehenate, glyceryl behenate, leucine, myristic acid, palmitic acid, poloxamer, polyethylene glycol, potassium benzoate, sodium benzoate, sodium stearate, stearic acid, talc, tribehenin or zinc stearate, preferably the extragranular lubricant is magnesium stearate, sodium stearyl fumarate or talc, more preferably magnesium stearate or sodium stearyl fumarate, most preferably magnesium stearate.

[0033] (19) The tablet according to any one of items (1) to (18), wherein the tablet comprises 40-90 wt.% of bempedoic acid, preferably 50-85 wt.% of bempedoic acid, more preferably 60-85 wt.% of bempedoic acid, even more preferably 60-80 wt.% of bempedoic acid, even more preferably 65-80 wt.% of bempedoic acid, even more preferably 65-75 wt.% of bempedoic acid, most preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules.

[0034] (20) The tablet according to any one of items (1) to (19), wherein the tablet comprises 60-80 wt.% of bempedoic acid, preferably 65-75 wt.% of bempedoic acid, more preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules.

[0035] (21) The tablet according to any one of items (1) to (19), wherein the tablet comprises 70-90 wt.% of bempedoic acid, preferably 80-90 wt.% of bempedoic acid, more preferably 85-90% of bempedoic acid relative to the total weight of the granules.

[0036] (22) The tablet according to any one of items (1) to (21), wherein the tablet comprises 30-60 wt.% of intragranular bempedoic acid, preferably 35-55 wt.% of intragranular bempedoic acid, more preferably 40-50% of intragranular bempedoic acid, most preferably 42-47 wt.% of intragranular bempedoic acid relative to the total weight of the tablet core.

[0037] (23) The tablet according to any one of items (6) to (22), wherein the tablet comprises 2-6 wt.% of intragranular ezetimibe, preferably 3-5 wt.% of intragranular ezetimibe relative to the total weight of the granules.

[0038] (24) The tablet according to any one of items (6) to (23), wherein the tablet comprises 1.5-5 wt.% of intragranular ezetimibe, preferably 2-4 wt.% of intragranular ezetimibe, more preferably 2-3 wt.% of intragranular ezetimibe relative to the total weight of the tablet core.

[0039] (25) The tablet according to any one of items (1) to (24), wherein the tablet comprises 4-50 wt.% of the intragranular diluent, preferably 10-50 wt.% of the intragranular diluent, more preferably 10-40 wt.% of the intragranular diluent, even more preferably 10-30 wt.% of the intragranular diluent, most preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules.

[0040] (26) The tablet according to any one of items (1) to (25), wherein the tablet comprises 2-40 wt.% of the intragranular diluent, preferably 5-40 wt.% of the intragranular diluent, more preferably 5-30 wt.% of the intragranular diluent, even more preferably 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core.

[0041] (27) The tablet according to any one of items (1) to (26), wherein the tablet comprises 4-50 wt.% of intragranular microcrystalline cellulose, preferably 10-50 wt.% of intragranular microcrystalline cellulose, more preferably 10-40 wt.% of intragranular microcrystalline cellulose, even more preferably 10-30 wt.% of intragranular microcrystalline cellulose, most preferably 15-25 wt.% of intragranular microcrystalline cellulose relative to the total weight of the granules.

[0042] (28) The tablet according to any one of items (1) to (27), wherein the tablet comprises 2-40 wt.% of intragranular microcrystalline cellulose, preferably 5-40 wt.% of intragranular microcrystalline cellulose, more preferably 5-30 wt.% of intragranular microcrystalline cellulose, even more preferably 5-20 wt.% of intragranular microcrystalline cellulose, most preferably 10-15 wt.% of intragranular microcrystalline cellulose relative to the total weight of the tablet core.

[0043] (29) The tablet according to any one of items (1) to (28), wherein the tablet comprises 4-50 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, preferably 10-50 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, more preferably 10-40 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, even more preferably 10-30 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, most preferably 15-25 wt.% of the intragranular mixture of microcrystalline cellulose and lactose relative to the total weight of the granules, wherein lactose is preferably lactose monohydrate.

[0044] (30) The tablet according to any one of items (1) to (29), wherein the tablet comprises 2-40 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, preferably 5-40 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, more preferably 5-30 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, even more preferably 5-20 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, most preferably 10-15 wt.% of the intragranular mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, wherein lactose is preferably lactose monohydrate.

[0045] (31) The tablet according to any one of items (1) to (30), wherein the tablet comprises 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 3-5 wt.% of the intragranular binder relative to the total weight of the granules.

[0046] (32) The tablet according to any one of items (1) to (31), wherein the tablet comprises 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably

[0047] 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core.

[0048] (33) The tablet according to any one of items (1) to (32), wherein the tablet comprises 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably

[0049] 3-5 wt.% of the intragranular binder relative to the total weight of the granules, wherein the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose. (34) The tablet according to any one of items (1) to (33), wherein the tablet comprises 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably

[0050] 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, wherein the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose.

[0051] (35) The tablet according to any one of items (1) to (34), wherein the tablet comprises 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant more preferably 3-5 wt.% of the intragranular disintegrant relative to the total weight of the granules.

[0052] (36) The tablet according to any one of items (1) to (35), wherein the tablet comprises 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core.

[0053] (37) The tablet according to any one of items (1) to (36), wherein the tablet comprises 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably

[0054] 3-5 wt.% of sodium starch glycolate relative to the total weight of the granules.

[0055] (38) The tablet according to any one of items (1) to (37), wherein the tablet comprises 1-8 wt.% of intragranular sodium starch glycolate, preferably 2-6 wt.% of intragranular sodium starch glycolate, more preferably 2-4 wt.% of intragranular sodium starch glycolate relative to the total weight of the tablet core.

[0056] (39) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (39), wherein the tablet comprises 0.5-3 wt.% of the intragranular glidant, preferably 1-2 wt.% of the intragranular glidant relative to the total weight of the granules.

[0057] (40) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (40), wherein the tablet comprises 0.5-3 wt.% of the intragranular glidant, preferably 0.5-2 wt.% of the intragranular glidant relative to the total weight of the tablet core.

[0058] (41) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (40), wherein the tablet comprises 0.5-3 wt.% of intragranular silicon dioxide, preferably 1-2 wt.% of intragranular silicon dioxide relative to the total weight of the granules, wherein silicon dioxide is preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0059] (42) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (41), wherein the tablet comprises 0.5-3 wt.% of intragranular silicon dioxide, preferably 0.5-2 wt.% of intragranular silicon dioxide relative to the total weight of the tablet core, wherein silicon dioxide is preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide. (43) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (42), wherein the tablet comprises 0.5-3 wt.% of the intragranular lubricant, preferably 1-2 wt.% of the intragranular lubricant relative to the total weight of the granules.

[0060] (44) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (43), wherein the tablet comprises 0.5-3 wt.% of the intragranular lubricant, preferably 0.5-2 wt.% of the intragranular lubricant relative to the total weight of the tablet core.

[0061] (45) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (44), wherein the tablet comprises 0.5-3 wt.% of intragranular magnesium stearate, preferably 1-2 wt.% of intragranular magnesium stearate relative to the total weight of the granules.

[0062] (46) The tablet according to any one of items (1) to (3), (5) to (7), or (9) to (45), wherein the tablet comprises 0.5-3 wt.% of intragranular magnesium stearate, preferably 0.5-2 wt.% of intragranular magnesium stearate relative to the total weight of the tablet core.

[0063] (47) The tablet according to any one of items (1) to (5), (9) to (22) or (25) to (46), wherein the tablet comprises 4-10 wt.% of extragranular ezetimibe, preferably 5-8 wt.% of extragranular ezetimibe, more preferably 6-7 wt.% of extragranular ezetimibe relative to the total weight of the extragranular phase.

[0064] (48) The tablet according to any one of items (1) to (5), (9) to (22) or (25) to (47), wherein the tablet comprises 1.5-5 wt.% of extragranular ezetimibe, preferably 2-4 wt.% of extragranular ezetimibe, more preferably 2-3 wt.% of extragranular ezetimibe relative to the total weight of the tablet core.

[0065] (49) The tablet according to any one of items (1) to (48), wherein the tablet comprises 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 65-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase.

[0066] (50) The tablet according to any one of items (1) to (49), wherein the tablet comprises 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core.

[0067] (51) The tablet according to any one of items (1) to (50), wherein the tablet comprises 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 65-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, wherein the extragranular diluent is microcrystalline cellulose, lactose or a mixture thereof, preferably a mixture of microcrystalline cellulose and lactose, wherein lactose is preferably lactose monohydrate.

[0068] (52) The tablet according to any one of items (1) to (51), wherein the tablet comprises 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, most preferably 20-30 wt.% of the extragranular diluent, relative to the total weight of the tablet core, wherein the extragranular diluent is microcrystalline cellulose, lactose or a mixture thereof, preferably a mixture of microcrystalline cellulose and lactose, wherein lactose is preferably lactose monohydrate.

[0069] (53) The tablet according to any one of items (1) to (52), wherein the tablet comprises 20-50 wt.% of extragranular microcrystalline cellulose and 20-50 wt.% of extragranular lactose, preferably 25-45 wt.% of extragranular microcrystalline cellulose and 30-50 wt.% of extragranular lactose, more preferably 25-40 wt.% of extragranular microcrystalline cellulose and 30-45 wt.% of extragranular lactose relative to the total weight of the extragranular phase, wherein lactose is preferably lactose monohydrate.

[0070] (54) The tablet according to any one of items (1) to (53), wherein the tablet comprises 5-30 wt.% of extragranular microcrystalline cellulose and 5-30 wt.% of extragranular lactose, preferably 5-20 wt.% of extragranular microcrystalline cellulose and 5-25 wt.% of extragranular lactose, more preferably 10-20 wt.% of extragranular microcrystalline cellulose and 10-25 wt.% of extragranular lactose, even more preferably 10-15 wt.% of extragranular microcrystalline cellulose and 10-15 wt.% of extragranular lactose relative to the total weight of the tablet core, wherein lactose is preferably lactose monohydrate.

[0071] (55) The tablet according to any one of items (1) to (54), wherein the tablet comprises 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase.

[0072] (56) The tablet according to any one of items (1) to (55), wherein the tablet comprises 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core.

[0073] (57) The tablet according to any one of items (1) to (56), wherein the tablet comprises 5-20 wt.% of the extragranular sodium starch glycolate, preferably 15-20 wt.% of the extragranular sodium starch glycolate, more preferably 5-15 wt.% of extragranular sodium starch glycolate, most preferably 8-14 wt.% of extragranular sodium starch glycolate relative to the total weight of the extragranular phase.

[0074] (58) The tablet according to any one of items (1) to (57), wherein the tablet comprises 2-10 wt.% of extragranular sodium starch glycolate, preferably 3-8 wt.% of extragranular sodium starch glycolate, more preferably 6-8 wt.% of extragranular sodium starch glycolate, most preferably 3-6 wt.% of extragranular sodium starch glycolate relative to the total weight of the tablet core.

[0075] (59) The tablet according to any one of items (1) to (58), wherein the tablet comprises 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase. (60) The tablet according to any one of items (1) to (59), wherein the tablet comprises 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core.

[0076] (61) The tablet according to any one of items (1) to (60), wherein the tablet comprises 0.5-3 wt.% of extragranular sodium lauryl sulfate, preferably 1-2 wt.% of extragranular sodium lauryl sulfate relative to the total weight of the extragranular phase.

[0077] (62) The tablet according to any one of items (1) to (61), wherein the tablet comprises 0.2-2 wt.% of extragranular sodium lauryl sulfate, preferably 0.3-1 wt.% of extragranular sodium lauryl sulfate relative to the total weight of the tablet core.

[0078] (63) The tablet according to any one of items (6) to (46) or (49) to (62), wherein the tablet comprises 0.3-2 wt.% of the intragranular solubilizing agent, preferably 0.5-1.5 wt.% of the intragranular solubilizing agent relative to the total weight of the granules.

[0079] (64) The tablet according to any one of items (6) to (46) or (49) to (63), wherein the tablet comprises 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the tablet core.

[0080] (65) The tablet according to any one of items (6) to (46) or (49) to (64), wherein the tablet comprises 0.3-2 wt.% of intragranular sodium lauryl sulfate, preferably 0.5-1.5 wt.% of intragranular sodium lauryl sulfate relative to the total weight of the granules.

[0081] (66) The tablet according to any one of items (6) to (46) or (49) to (65), wherein the tablet comprises 0.2-2 wt.% of intragranular sodium lauryl sulfate, preferably 0.3-1 wt.% of intragranular sodium lauryl sulfate relative to the total weight of the tablet core.

[0082] (67) The tablet according to any one of items (1) to (66), wherein the tablet comprises 0.2-6 wt.% of the extragranular glidant, preferably 1-6 wt.% of the extragranular glidant or 0.2-1 wt.% of the extragranular glidant, more preferably 0.2-0.5 wt.% of the extragranular glidant, most preferably 1-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase.

[0083] (68) The tablet according to any one of items (1) to (67), wherein the tablet comprises 1-6 wt.% of the extragranular glidant, preferably 1-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase.

[0084] (69) The tablet according to any one of items (1) to (67), wherein the tablet comprises 0.2-1 wt.% of the extragranular glidant, preferably 0.2-0.5 wt.% of the extragranular glidant relative to the total weight of the extragranular phase.

[0085] (70) The tablet according to any one of items (1) to (67), wherein the tablet comprises 0.1-3 wt.% of the extragranular glidant, preferably 0.3-2 wt.% of the extragranular glidant or 0. 1-1 wt.% of the extragranular glidant, more preferably 0. 1-0.5 wt.% of the extragranular glidant, even more preferably 0.1-0.3 wt.% of the extragranular glidant, most preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core. (71) The tablet according to any one of items (1) to (68) or (70), wherein the tablet comprises 0.3- 2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core.

[0086] (72) The tablet according to any one of items (1) to (67), (69) or (70), wherein the tablet comprises 0.1-1 wt.% of the extragranular glidant, more preferably 0.1-0.5 wt.% of the extragranular glidant, more preferably 0.1-0.3 wt.% of the extragranular glidant relative to the total weight of the tablet core.

[0087] (73) The tablet according to any one of items (1) to (67) or (70), wherein the tablet comprises 0.2- 6 wt.% of extragranular silicon dioxide, preferably 1-6 wt.% of extragranular silicon dioxide or 0.2-1 wt.% of extragranular silicon dioxide, more preferably 0.2-0.5 wt.% of extragranular silicon dioxide, most preferably 1-4 wt.% of extragranular silicon dioxide relative to the total weight of the extragranular phase, wherein silicon dioxide is preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0088] (74) The tablet according to any one of items (1) to (68), (70), (71) or (73) wherein the tablet comprises 1-6 wt.% of extragranular silicon dioxide, preferably 1-4 wt.% of extragranular silicon dioxide relative to the total weight of the extragranular phase, wherein silicon dioxide is preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0089] (75) The tablet according to any one of items (1) to (67), (69), (70), (72) or (73) wherein the tablet comprises 0.2-1 wt.% of extragranular silicon dioxide, preferably 0.2-0.5 wt.% of extragranular silicon dioxide relative to the total weight of the extragranular phase, wherein silicon dioxide is preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0090] (76) The tablet according to any one of items (1) to (67), (70) or (73), wherein the tablet comprises 0.1-2 wt.% of extragranular silicon dioxide, preferably 0.3-2 wt.% of the extragranular silicon dioxide or 0.1-1 wt.% of extragranular silicon dioxide, more preferably 0.1-0.5 wt.% of extragranular silicon dioxide, most preferably 0.5-2 wt.% of extragranular silicon dioxide relative to the total weight of the tablet core, wherein silicon dioxide is preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0091] (77) The tablet according to any one of items (1) to (67), (69), (70), (72), (73) or (75), wherein the tablet comprises 0.3-2 wt.% of the extragranular colloidal silicon dioxide, preferably 0.5-2 wt.% of extragranular silicon dioxide relative to the total weight of the tablet core, wherein silicon dioxide is preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0092] (78) The tablet according to any one of items (1) to (67), (69), (70), (72), (73) or 75. wherein the tablet comprises 0.1-1 wt.% of extragranular silicon dioxide, preferably 0.1-0.5 wt.% of extragranular silicon dioxide relative to the total weight of the tablet core, wherein silicon dioxide is preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0093] (79) The tablet according to any one of items (1) to (78), wherein the tablet comprises 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0094] (80) The tablet according to any one of items (1) to (79), wherein the tablet comprises 1-5 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0095] (81) The tablet according to any one of items (1) to (79), wherein the tablet comprises 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0096] (82) The tablet according to any one of items (1) to (79), wherein the tablet comprises 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0097] (83) The tablet according to any one of items (1) to (80) or (82), wherein the tablet comprises 1-2 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0098] (84) The tablet according to any one of items (1) to (79), (81) or (82), wherein the tablet comprises 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0099] (85) The tablet according to any one of items (1) to (79) or (82), wherein the tablet comprises 1- 15 wt.% of extragranular magnesium stearate or sodium stearyl fumarate, preferably 1-5 wt.% of the extragranular magnesium stearate or sodium stearyl fumarate, more preferably 5-10 wt.% of extragranular magnesium stearate or sodium stearyl fumarate relative to the total weight of the extragranular phase.

[0100] (86) The tablet according to any one of items (1) to (80), (82), (83) or (85), wherein the tablet comprises 1-5 wt.% of extragranular magnesium stearate or sodium stearyl fumarate relative to the total weight of the extragranular phase.

[0101] (87) The tablet according to any one of items (1) to (79), (81), (82), (84) or (85), wherein the tablet comprises 5-10 wt.% of extragranular magnesium stearate or sodium stearyl fumarate relative to the total weight of the extragranular phase.

[0102] (88) The tablet according to any one of items (1) to (79), (82), or (85), wherein the tablet comprises 0.5-5 wt.% of extragranular magnesium stearate or sodium stearyl fumarate, preferably 1-4 wt.% of extragranular magnesium stearate or sodium stearyl fumarate, more preferably 1-2 wt.% of extragranular magnesium stearate or sodium stearyl fumarate, most preferably 2-4 wt.% of extragranular magnesium stearate or sodium stearyl fumarate relative to the total weight of the tablet core.

[0103] (89) The tablet according to any one of items (1) to (80), (82), (83), (85), (86) or (88), wherein the tablet comprises 1-2 wt.% of extragranular magnesium stearate or sodium stearyl fumarate relative to the total weight of the tablet core. (90) The tablet according to any one of items (1) to (79), (81), (82), (84), (85), (87) or (88), wherein the tablet comprises 2-4 wt.% of extragranular magnesium stearate or sodium stearyl fumarate relative to the total weight of the tablet core.

[0104] (91) The tablet according to any one of items (79) to (90), wherein the extragranular lubricant is magnesium stearate.

[0105] (92) The tablet according to any one of items (79) to (90), wherein the extragranular lubricant is sodium stearyl fumarate.

[0106] (93) The tablet according to any one of items (1) to (5), (9) to (22), or (25) to (92), in particular according to any item not referring back to item (6), wherein the tablet comprises: b) the extragranular phase comprising: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 65- 75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase, b5) optionally, 0.2-6 wt.% of the extragranular glidant, preferably 1-6 wt.% of the extragranular glidant or 0.2-1 wt.% of the extragranular glidant, more preferably 0.2- 0.5 wt.% of the extragranular glidant, most preferably 1-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0107] (94) The tablet according to any one of items (1) to (5), (9) to (22), or (25) to (93), in particular according to any item not referring back to item (6), wherein the tablet comprises: b) the extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.1-2 wt.% of the extragranular glidant, preferably 0.3-2 wt.% of the extragranular glidant or 0. 1-0.3 wt.% of the extragranular glidant, more preferably 0.1- 0.2 wt.% of the extragranular glidant, most preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0108] (95) The tablet according to any one of items (1) to (5), (9) to (22), or (25) to (94), in particular according to any item not referring back to item (6), wherein the tablet comprises: a) the granules comprising: al) 40-90 wt.% of bempedoic acid, preferably 50-85 wt.% of bempedoic acid, more preferably 60-85 wt.% of bempedoic acid, even more preferably 60-80 wt.% of bempedoic acid, even more preferably 65-80 wt.% of bempedoic acid, even more preferably 65-75 wt.% of bempedoic acid, most preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 4-50 wt.% of the intragranular diluent, preferably 10-50 wt.% of the intragranular diluent, more preferably 10-40 wt.% of the intragranular diluent, even more preferably 10-30 wt.% of the intragranular diluent, most preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 3-5 wt.% of the intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 3-5 wt.% of the intragranular disintegrant relative to the total weight of the granules, a5) optionally, 0.5-3 wt.% of the intragranular glidant, preferably 1-2 wt.% of the intragranular glidant relative to the total weight of the granules, a6) optionally, 0.5-3 wt.% of the intragranular lubricant, preferably 1-2 wt.% of the intragranular lubricant relative to the total weight of the granules.

[0109] (96) The tablet according to any one of items (1) to (5), (9) to (22), or (25) to (95), in particular according to any item not referring back to item (6), wherein the tablet comprises: a) the granules consisting of: al) 40-90 wt.% of bempedoic acid, preferably 50-85 wt.% of bempedoic acid, more preferably 60-85 wt.% of bempedoic acid, even more preferably 60-80 wt.% of bempedoic acid, even more preferably 65-80 wt.% of bempedoic acid, even more preferably 65-75 wt.% of bempedoic acid, most preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 4-50 wt.% of the intragranular diluent, preferably 10-50 wt.% of the intragranular diluent, more preferably 10-40 wt.% of the intragranular diluent, even more preferably 10-30 wt.% of the intragranular diluent, most preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 3-5 wt.% of the intragranular binder relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 3-5 wt.% of the intragranular disintegrant relative to the total weight of the granules.

[0110] (97) The tablet according to any one of items (1) to (5), (9) to (22), or (25) to (95), in particular according to any item not referring back to item (6), wherein the tablet comprises: a) the granules consisting of: al) 40-90 wt.% of bempedoic acid, preferably 50-85 wt.% of bempedoic acid, more preferably 60-85 wt.% of bempedoic acid, even more preferably 60-80 wt.% of bempedoic acid, even more preferably 65-80 wt.% of bempedoic acid, even more preferably 65-75 wt.% of bempedoic acid, most preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 4-50 wt.% of the intragranular diluent, preferably 10-50 wt.% of the intragranular diluent, more preferably 10-40 wt.% of the intragranular diluent, even more preferably 10-30 wt.% of the intragranular diluent, most preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 3-5 wt.% of the intragranular binder relative to the total weight of the granules.

[0111] (98) The tablet according to any one of items (1) to (5), (9) to (22), or (25) to (97), in particular according to any item not referring back to item (6), wherein the tablet comprises: a) the granules comprising: al) 30-60 wt.% of intragranular bempedoic acid, preferably 35-55 wt.% of intragranular bempedoic acid, more preferably 40-50% of intragranular bempedoic acid, most preferably 42-47 wt.% of intragranular bempedoic acid relative to the total weight of the tablet core, a2) 5-40 wt.% of the intragranular diluent, preferably 5-30 wt.% of the intragranular diluent, more preferably 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, a5) optionally, 0.5-3 wt.% of the intragranular glidant, more preferably 0.5-2 wt.% of the intragranular glidant relative to the total weight of the tablet core, a6) optionally, 0.5-3 wt.% of the intragranular lubricant, more preferably 0.5-2 wt.% of the intragranular lubricant relative to the total weight of the tablet core.

[0112] (99) The tablet according to any one of items (1) to (5), (9) to (22), or (25) to (98), in particular according to any item not referring back to item (6), wherein the tablet comprises: a) the granules consisting of: al) 30-60 wt.% of intragranular bempedoic acid, preferably 35-55 wt.% of intragranular bempedoic acid, more preferably 40-50% of intragranular bempedoic acid, most preferably 42-47 wt.% of intragranular bempedoic acid relative to the total weight of the tablet core, a2) 5-40 wt.% of the intragranular diluent, preferably 5-30 wt.% of the intragranular diluent, more preferably 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core.

[0113] (100) The tablet according to any one of items (1) to (5), (9) to (22), or (25) to (98), in particular according to any item not referring back to item (6), wherein the tablet comprises: a) the granules consisting of: al) 30-60 wt.% of intragranular bempedoic acid, preferably 35-55 wt.% of intragranular bempedoic acid, more preferably 40-50% of intragranular bempedoic acid, most preferably 42-47 wt.% of intragranular bempedoic acid relative to the total weight of the tablet core, a2) 5-40 wt.% of the intragranular diluent, preferably 5-30 wt.% of the intragranular diluent, more preferably 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core.

[0114] (101) The tablet according to any one of items (6) to (46) or (49) to (92), wherein the tablet comprises: a) the granules comprising: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules, a6) optionally, 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules, a7) optionally, 0.5-3 wt.% of the intragranular glidant, preferably 1-2 wt.% of the intragranular glidant relative to the total weight of the granules, a8) optionally, 0.5-3 wt.% of the intragranular lubricant, preferably 1-2 wt.% of the intragranular lubricant relative to the total weight of the granules.

[0115] (102) The tablet according to any one of items (6) to (46), (49) to (92) or (101), wherein the tablet comprises: a) the granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules.

[0116] (103) The tablet according to any one of items (6) to (46), (49) to (92) or (101), in particular according to any item not referring back to item (6), wherein the tablet comprises: a) the granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules.

[0117] (104) The tablet according to any one of items (6) to (46), (49) to (92) or (101), wherein the tablet comprises: a) the granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules, a5) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a6) 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules.

[0118] (105) The tablet according to any one of items (6) to (46), (49) to (92) or (101) to (104), wherein the tablet comprises: b) the extragranular phase comprising: bl) 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, even more preferably 65-80 wt.% of the extragranular diluent, most preferably 70-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, b2) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b3) optionally, 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase, b4) optionally, 1-5 wt.% of the extragranular glidant, preferably 2-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase, b5) optionally, 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0119] (106) The tablet according to any one of items (6) to (46), (49) to (92), (101) to (105), wherein the tablet comprises: a) the granules comprising: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, a3) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a5) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, a6) optionally, 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the tablet core, a7) optionally, 0.5-3 wt.% of the intragranular glidant, more preferably 0.5-2 wt.% of the intragranular glidant relative to the total weight of the tablet core, a8) optionally, 0.5-3 wt.% of the intragranular lubricant, more preferably 0.5-2 wt.% of the intragranular lubricant relative to the total weight of the tablet core.

[0120] (107) The tablet according to any one of items (6) to (46), (49) to (92), (101) or (105) to (106), wherein the tablet comprises: a) the granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, a3) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a5) 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core.

[0121] (108) The tablet according to any one of items (6) to (46), (49) to (92), (101) or (105) to (106), wherein the tablet comprises: a) the granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, a3) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core.

[0122] (109) The tablet according to any one of items (6) to (46), (49) to (92), (101) or (105) to (106), wherein the tablet comprises: a) the granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, a3) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a5) 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, a6) 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the tablet core.

[0123] (110) The tablet according to any one of items (6) to (46), (49) to (92), (101) or (105) to (106), wherein the tablet comprises: a) the granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, a3) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a5) 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the tablet core.

[0124] (111) The tablet according to any one of items (6) to (46), (49) to (92) or (101) to (110), wherein the tablet comprises: b) the extragranular phase comprising: bl) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b2) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular water-soluble acid relative to the total weight of the tablet core, b4) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b5) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0125] (112) The tablet according to any one of items (1) to (111), wherein the intragranular diluent is microcrystalline cellulose.

[0126] (113) The tablet according to any one of items (1) to (111), wherein the intragranular diluent is a mixture of microcrystalline cellulose and lactose, preferably a mixture of microcrystalline cellulose and lactose monohydrate.

[0127] (114) The tablet according to any one of items (1) to (113), wherein the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose.

[0128] (115) The tablet according to any one of items (1) to (114), wherein the intragranular disintegrant is sodium starch glycolate.

[0129] (116) The tablet according to any one of items (1) to (3), (5) to (7), (9) to (95), (98), (101), (106) or (111) to (115), wherein the intragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide. (117) The tablet according to any one of items (1) to (3), (5) to (7), (9) to (95), (98), (101), (106) or (111) to (116), wherein the intragranular lubricant is magnesium stearate.

[0130] (118) The tablet according to any one of items (1) to (117), wherein the intragranular solubilizing agent or the extragranular solubilizing agent is sodium lauryl sulfate.

[0131] (119) The tablet according to any one of items (1) to (118), wherein the extragranular diluent is a mixture of microcrystalline cellulose and lactose, preferably a mixture of microcrystalline cellulose and lactose monohydrate.

[0132] (120) The tablet according to any one of items (1) to (119), wherein the extragranular phase comprises 20-50 wt.% of extragranular microcrystalline cellulose and 20-50 wt.% of extragranular lactose, preferably 25-45 wt.% of extragranular microcrystalline cellulose and 30-50 wt.% of extragranular lactose, more preferably 25-40 wt.% of extragranular microcrystalline cellulose and 30-45 wt.% of extragranular lactose relative to the total weight of the extragranular phase, wherein lactose is preferably lactose monohydrate.

[0133] (121) The tablet according to any one of items (1) to (120), wherein the tablet comprises 5-30 wt.% of extragranular microcrystalline cellulose and 5-30 wt.% of extragranular lactose, preferably 5-20 wt.% of extragranular microcrystalline cellulose and 5-25 wt.% of extragranular lactose, more preferably 10-20 wt.% of extragranular microcrystalline cellulose and 10-25 wt.% of extragranular lactose, even more preferably 10-15 wt.% of extragranular microcrystalline cellulose and 15-25 wt.% of extragranular lactose, even more preferably 10-15 wt.% of extragranular microcrystalline cellulose and 20-25 wt.% of extragranular lactose relative to the total weight of the tablet core, wherein lactose is preferably lactose monohydrate.

[0134] (122) The tablet according to any one of items (1) to (121), wherein the extragranular disintegrant is sodium starch glycolate.

[0135] (123) The tablet according to any one of items (1) to (122), wherein the extragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0136] (124) The tablet according to any one of items (1) to (123), wherein the extragranular lubricant is magnesium stearate or sodium stearyl fumarate, preferably magnesium stearate.

[0137] (125) A process for preparing the tablet according to any one of items (1) to (5), (9) to (22), (25) to (100), or (112) to (124), in particular according to any item not referring back to item (6), comprising the following steps: a) preparing granules comprising bempedoic acid, the intragranular diluent, the intragranular binder, optionally, the intragranular disintegrant and, optionally, the intragranular glidant and / or the intragranular lubricant, b) mixing granules with ezetimibe and extragranular excipients comprising the extragranular diluent, the extragranular disintegrant, the extragranular solubilizing agent and optionally, the extragranular glidant and / or the extragranular lubricant, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating. (126) A process for preparing the tablet according to any one of items (1) to (5), (9) to (22), (25) to (100), or (112) to (124), in particular according to any item not referring back to item (6), comprising the following steps: a) preparing granulation liquid by dissolving the intragranular binder in water, b) mixing bempedoic acid, the intragranular diluent, the intragranular disintegrant and optionally, the intragranular glidant and / or the intragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with ezetimibe, the extragranular diluent, the extragranular disintegrant, the extragranular solubilizing agent and optionally, the extragranular glidant and / or the extragranular lubricant, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0138] (127) A process for preparing the tablet according to any one of items (1) to (5), (9) to (22), (25) to (100), or (112) to (124), in particular according to any item not referring back to item (6), comprising the following steps: a) mixing bempedoic acid, the intragranular binder, the intragranular diluent, the intragranular disintegrant and optionally, the intragranular glidant and / or the intragranular lubricant to obtain granulating mixture, b) spraying a granulation liquid comprising water on the granulating mixture obtained in step a), preferably in a high-shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing granules with ezetimibe, the extragranular diluent, the extragranular disintegrant, the extragranular solubilizing agent and optionally, the extragranular glidant and / or the extragranular lubricant, f) compressing the mixture obtained in step e) to tablets, g) optionally, coating obtained tablet cores with a fdm-coating.

[0139] (128) A process for preparing the tablet according to any one of items (1) to (5), (9) to (22), (25) to (100), or (112) to (124), in particular according to any item not referring back to item (6), comprising the following steps: a) preparing granules comprising bempedoic acid, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate, b) mixing granules with ezetimibe, microcrystalline cellulose, lactose, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating. (129) A process for preparing the tablet according to any one of items (1) to (5), (9) to (22), (25) to (100), or (112) to (124), in particular according to any item not referring back to item (6), comprising the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose in water, b) mixing bempedoic acid, microcrystalline cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with ezetimibe, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a fdm-coating.

[0140] (130) A process for preparing the tablet according to any one of items (1) to (5), (9) to (22), (25) to

[0141] (100), or (112) to (124), in particular according to any item not referring back to item (6), comprising the following steps: a) mixing bempedoic acid, hydroxypropyl cellulose, microcrystalline cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, b) spraying water on the granulating mixture obtained in step a), preferably in a high- shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing granules with ezetimibe, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, f) compressing the mixture obtained in step e) to tablets, g) optionally, coating obtained tablet cores with a film-coating.

[0142] (131) A process for preparing the tablet according to any one of items (6) to (46), (49) to (92),

[0143] (101) to (124) comprising the following steps: a) preparing granules comprising bempedoic acid, ezetimibe, the intragranular diluent, the intragranular binder, the intragranular disintegrant, optionally, the intragranular solubilizing agent, and, optionally, the intragranular glidant and / or the intragranular lubricant, b) mixing granules with ezetimibe and extragranular excipients comprising the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and optionally, the extragranular glidant and / or the extragranular lubricant, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating.

[0144] (132) A process for preparing the tablet according to any one of items (6) to (46), (49) to (92),

[0145] (101) to (124) comprising the following steps: a) preparing granulation liquid by dissolving the intragranular binder and, optionally, the intragranular solubilizing agent, in water, b) mixing bempedoic acid, the intragranular diluent, optionally, the intragranular disintegrant, optionally, the intragranular solubilizing agent, and optionally, the intragranular glidant and / or the intragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and optionally, the extragranular glidant and / or the extragranular lubricant, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0146] (133) A process for preparing the tablet according to any one of items (6) to (46), (49) to (92),

[0147] (101) to (124) comprising the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving the intragranular binder and, optionally, the intragranular solubilizing agent, in water, b) mixing bempedoic acid, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the intragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and optionally, the extragranular glidant and / or the extragranular lubricant, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0148] (134) A process for preparing the tablet according to any one of items (6) to (46), (49) to (92),

[0149] (101) to (124) comprising the following steps: a) mixing bempedoic acid, ezetimibe, the intragranular diluent, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, b) spraying a granulation liquid comprising water on the granulating mixture obtained in step a), preferably in a high-shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing granules with microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, f) compressing the mixture obtained in step e) to tablets, g) optionally, coating obtained tablet cores with a film-coating. (135) A process for preparing the tablet according to any one of items (6) to (46), (49) to (92),

[0150] (101) to (124) comprising the following steps: a) preparing granules comprising bempedoic acid, ezetimibe, microcrystalline cellulose, hydroxypropyl cellulose, optionally, sodium starch glycolate, optionally, sodium lauryl sulfate, and, optionally, silicon dioxide and / or magnesium stearate, b) mixing granules with microcrystalline cellulose, lactose, sodium starch glycolate, optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating.

[0151] (136) A process for preparing the tablet according to any one of items (6) to (46), (49) to (92),

[0152] (101) to (124) comprising the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose, and optionally, sodium lauryl sulfate in water, b) mixing bempedoic acid, ezetimibe, microcrystalline cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with microcrystalline cellulose, lactose, sodium starch glycolate, optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate, g) compressing obtained mixture to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0153] (137) A process for preparing the tablet according to any one of items (6) to (46), (49) to (92),

[0154] (101) to (124) comprising the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving hydroxypropyl cellulose and optionally, sodium lauryl sulfate, in water, b) mixing bempedoic acid, microcrystalline cellulose, optionally, sodium starch glycolate, optionally, sodium lauryl sulfate, and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with microcrystalline cellulose, lactose, sodium starch glycolate, optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0155] (138) A process for preparing the tablet according to any one of items (125) to (137), wherein lactose in lactose monohydrate. (139) A process for preparing the tablet according to any one of items (125) to (138), wherein silicon dioxide is colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0156] (140) Bempedoic acid granules consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of intragranular diluent, preferably 15-25 wt.% of intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of intragranular binder, preferably 2-6 wt.% of intragranular binder, more preferably 3-5 wt.% of intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of intragranular disintegrant, preferably 2-6 wt.% of intragranular disintegrant, more preferably 3-5 wt.% of intragranular disintegrant relative to the total weight of the granules.

[0157] (141) Bempedoic acid granules comprised in a tablet core, the bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid or 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core.

[0158] (142) Bempedoic acid granules according to item (140) or item (141), wherein the intragranular diluent is selected from microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch or a mixture thereof, preferably the intragranular diluent is microcrystalline cellulose, lactose, or a mixture thereof, more preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, even more preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, most preferably microcrystalline cellulose.

[0159] (143) Bempedoic acid granules according to any one of items (140) to (142), wherein the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose.

[0160] (144) Bempedoic acid granules according to any one of items (140) to (143), wherein the intragranular disintegrant is selected from sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium, sodium starch glycolate or low-substituted hydroxypropyl cellulose, preferably the intragranular disintegrant is sodium starch glycolate.

[0161] (145) Bempedoic acid granules according to any one of items (140) to (144) consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of microcrystalline cellulose, preferably 15-25 wt.% of microcrystalline cellulose relative to the total weight of the granules, a3) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 3-5 wt.% of hydroxypropyl cellulose relative to the total weight of the granules, a4) 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 3-5 wt.% of sodium starch glycolate relative to the total weight of the granules.

[0162] (146) Bempedoic acid granules according to any one of items (140) to (145) comprised in a tablet core, the bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid or 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core.

[0163] (147) A tablet, in particular comprising a tablet core and optionally a coating, the tablet comprising bempedoic acid granules according to any one of items (140) to (146).

[0164] (148) The tablet according to item (147) comprising: a) bempedoic acid granules according to any one of items (140) to (146), b) an extragranular phase comprising: bl) an extragranular diluent, b2) optionally, an extragranular disintegrant, b3) optionally, an extragranular glidant, b4) optionally, an extragranular lubricant.

[0165] (149) The tablet according to item (148) comprising 50-90 wt.% of bempedoic acid granules, preferably 55-80 wt.% of bempedoic acid granules, more preferably 60-75 wt.% of bempedoic acid granules, most preferably 65-75 wt.% of bempedoic acid granules according to any one of items (140) to (146) relative to the total weight of the tablet core.

[0166] (150) The tablet according to item (148) or item (149), wherein the tablet comprises: a) 50-90 wt.% of bempedoic acid granules, preferably 55-80 wt.% of bempedoic acid granules, more preferably 60-75 wt.% of bempedoic acid granules, most preferably 65- 75 wt.% of bempedoic acid granules according to any one of items (1) to (5) relative to the total weight of the tablet core, b) 10-50 wt.% of the extragranular phase, preferably 20-45 wt.% of the extragranular phase, more preferably 25-40 wt.% of the extragranular phase, most preferably 25-35 wt.% of the extragranular phase relative to the total weight of the tablet core.

[0167] (151) The tablet according to item (147) comprising: a) bempedoic acid granules according to any one of items (140) to (146), b) the granules comprising ezetimibe, c) the extragranular phase comprising: cl) an extragranular diluent, c2) optionally, an extragranular disintegrant, c3) optionally, an extragranular glidant, c4) optionally, an extragranular lubricant.

[0168] (152) The tablet according to item (151) comprising: a) 50-75 wt.% of bempedoic acid granules, preferably 55-70 wt.% of bempedoic acid granules, more preferably 60-65 wt.% of bempedoic acid granules according to any one of items (140) to (146) relative to the total weight of the tablet core, b) 15-25 wt.% of the granules comprising ezetimibe relative to the total weight of the tablet core.

[0169] (153) The tablet according to item (151) or item (152) comprising: a) 50-75 wt.% of bempedoic acid granules, preferably 55-70 wt.% of bempedoic acid granules, more preferably 60-65 wt.% of bempedoic acid granules according to any one of items (140) to (146) relative to the total weight of the tablet core, b) 15-25 wt.% of the granules comprising ezetimibe relative to the total weight of the tablet core c) 10-25 wt.% of the extragranular phase relative to the total weight of the tablet core.

[0170] (154) The tablet according to any one of items (147) to (153), wherein the tablet comprises 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 60-70 wt.% of the extragranular diluent relative to the total weight of the extragranular phase.

[0171] (155) The tablet according to any one of items (147) to (154), wherein the tablet comprises 5-20 wt.% of the extragranular disintegrant, preferably 10-20 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase.

[0172] (156) The tablet according to any one of items (147) to (155), wherein the tablet comprises 3-8 wt.% of the extragranular glidant, preferably 5-7 wt.% of the extragranular glidant relative to the total weight of the extragranular phase.

[0173] (157) The tablet according to any one of items (147) to (155), wherein the tablet comprises 0.5-3 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the extragranular phase.

[0174] (158) The tablet according to any one of items (147) to (157), wherein the tablet comprises 1-20 wt.% of the extragranular lubricant, preferably 10-20 wt.% of the extragranular lubricant, more preferably 15-20 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0175] (159) The tablet according to any one of items (147) to (158), wherein the tablet comprises 10-25 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 10-20 wt.% of the extragranular diluent relative to the total weight of the tablet core.

[0176] (160) The tablet according to any one of items (147) to (159), wherein the tablet comprises 10-15 wt.% of the extragranular diluent relative to the total weight of the tablet core.

[0177] (161) The tablet according to any one of items (147) to (160), wherein the tablet comprises 15-20 wt.% of the extragranular diluent relative to the total weight of the tablet core.

[0178] (162) The tablet according to any one of items (147) to (161), wherein the tablet comprises 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core.

[0179] (163) The tablet according to any one of items (147) to (162), wherein the tablet comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core.

[0180] (164) The tablet according to any one of items (147) to (163), wherein the tablet comprises 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0181] (165) The tablet according to any one of items (147) to (150), (154) to (164), wherein the tablet comprises: a) bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, more preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) the extragranular phase comprising: bl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, b2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0182] (166) The tablet according to any one of items (147) to (150), (154) to (165), wherein the tablet comprises: a) 50-90 wt.% of bempedoic acid granules, preferably 55-80 wt.% of bempedoic acid granules, more preferably 60-75 wt.% of bempedoic acid granules, most preferably 65- 75 wt.% of bempedoic acid granules relative to the total weight of the tablet core, wherein the bempedoic acid granules are consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) 10-50 wt.% of the extragranular phase, preferably 20-45 wt.% of the extragranular phase, preferably 25-40 wt.% of the extragranular phase, most preferably 25-35 wt.% of the extragranular phase relative to the total weight of the tablet core, wherein the extragranular phase comprises: bl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, b2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0183] (167) The tablet according to any one of items (147), (151) to (164), wherein the tablet comprises: a) the granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) the granules comprising ezetimibe, c) the extragranular phase comprising: cl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 10-15 wt.% of the extragranular diluent, relative to the total weight of the tablet core, c2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, c4) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0184] (168) The tablet according to any one of items (147), (151) to (164) or (167), wherein the tablet comprises: a) 50-90 wt.% of bempedoic acid granules, preferably 55-80 wt.% of bempedoic acid granules, more preferably 60-75 wt.% of bempedoic acid granules relative to the total weight of the tablet core, wherein bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) 15-25 wt.% of the granules comprising ezetimibe relative to the total weight of the tablet core, c) 10-25 wt.% of the extragranular phase relative to the total weight of the tablet core, wherein the extragranular phase comprises: cl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, c2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, c4) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0185] (169) The tablet according to any one of items (147) to (168), wherein the extragranular diluent is selected from microcrystalline cellulose, mannitol, lactose, lactose monohydrate, lactose anhydrous, sorbitol, starch, sucrose, calcium carbonate, calcium phosphate, calcium sulfate, erythritol, fructose, inulin, isomalt, lactitol, magnesium carbonate, magnesium oxide, maltitol, maltodextrin, maltose, polydextrose, sodium bicarbonate, sodium carbonate, sodium chloride, trehalose, xylitol, cellulose acetate, or a mixture thereof, preferably the extragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, more preferably microcrystalline cellulose, lactose or a mixture thereof.

[0186] (170) The tablet according to any one of items (147) to (169), wherein the extragranular diluent is a mixture of microcrystalline cellulose and lactose, preferably a mixture of microcrystalline cellulose and lactose monohydrate.

[0187] (171) The tablet according to any one of items (147) to (170), wherein a weight ratio between extragranular microcrystalline cellulose and extragranular lactose is between 1:3 to 3: 1, preferably between 1 :2 to 2: 1.

[0188] (172) The tablet according to any one of items (147) to (171), wherein the extragranular diluent is microcrystalline cellulose.

[0189] (173) The tablet according to any one of items (147) to (172), wherein the extragranular disintegrant is selected from sodium starch glycolate, croscarmellose sodium, low- substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone, carboxymethylcellulose calcium, pregelatinized starch, alginic acid, calcium alginate, chitosan, carboxymethylcellulose calcium, guar gum, magnesium aluminium silicate, methylcellulose, povidone, sodium alginate or starch, preferably the extragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium, sodium starch glycolate or low-substituted hydroxypropyl cellulose, more preferably sodium starch glycolate.

[0190] (174) The tablet according to any one of items (147) to (173), wherein the extragranular glidant is selected from silicon dioxide, colloidal silicon dioxide, anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide, hydrophobic colloidal silicon dioxide, talc, magnesium silicate, magnesium trisilicate, tribasic calcium phosphate, powdered cellulose, magnesium oxide, sodium stearate or sodium stearyl fumarate, preferably the extragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, more preferably colloidal silicon dioxide, even more preferably anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide or hydrophobic colloidal silicon dioxide, most preferably anhydrous colloidal silicon dioxide.

[0191] (175) The tablet according to any one of items (147) to (174), wherein the extragranular lubricant is selected from magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl monostearate, glyceryl palmitostearate, glyceryl dibehenate, glyceryl behenate, leucine, myristic acid, palmitic acid, poloxamer, polyethylene glycol, potassium benzoate, sodium benzoate, sodium stearate, stearic acid, talc, tribehenin or zinc stearate, preferably the extragranular lubricant is magnesium stearate, sodium stearyl fumarate or talc, more preferably magnesium stearate.

[0192] (176) Tablet according to any one of items (147), (151) to (164), (167) to (175), wherein the granules comprising ezetimibe comprises: bl) 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-20 wt.% of intragranular diluent, preferably 10-15 wt.% of intragranular diluent relative to the total weight of the tablet core, b3) 0.1-1 wt.% of intragranular solubilizing agent, preferably 0.2-0.8 wt.% of intragranular solubilizing agent relative to the total weight of the tablet core, b4) 0. 1-2 wt.% of intragranular binder, preferably 0.2-1 wt.% of intragranular binder relative to the total weight of the tablet core, b5) 0.5-3 wt.% of intragranular disintegrant, preferably 0.5-2 wt.% of intragranular disintegrant relative to the total weight of the tablet core.

[0193] (177) Tablet according to any one of items (147), (151) to (164), (167) to (176), wherein the granules comprising ezetimibe comprises: bl) 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-20 wt.% of microcrystalline cellulose, lactose or a mixture thereof, preferably 12- 17 wt.% of microcrystalline cellulose, lactose or a mixture thereof relative to the total weight of the tablet core, b3) 0.1-1 wt.% of sodium lauryl sulfate, preferably 0.2-0.8 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b4) 0. 1-2 wt.% of povidone, preferably 0.2-1 wt.% of povidone to the total weight of the tablet core, b5) 0.5-3 wt.% of sodium starch glycolate, preferably 0.5-2 wt.% of sodium starch glycolate relative to the total weight of the tablet core.

[0194] (178) A process for preparing bempedoic acid granules, in particular according to any one of items (140) to (146), comprising the following steps: a) preparing granulation liquid by dissolving the intragranular binder in water, b) mixing bempedoic acid, the intragranular diluent and the intragranular disintegrant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules.

[0195] (179) The process for preparing bempedoic acid granule according to items (178) comprising the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose in water, b) mixing bempedoic acid, microcrystalline cellulose and sodium starch glycolate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules.

[0196] (180) A process for preparing the tablet according to any one of items (147) to (150), (154) to

[0197] (166), or (170) to (176) comprising the following steps: a) preparing bempedoic acid granules, preferably by the process according to item (178) or item (179), b) mixing bempedoic acid granules with extragranular excipients comprising the extragranular diluent, optionally, the extragranular disintegrant, optionally, the extragranular solubilizing agent optionally, the extragranular glidant, and optionally, the extragranular lubricant, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating.

[0198] (181) A process for preparing the tablet according to any one of items (147), (151) to (164), or

[0199] (167) to (176) comprising the following steps: a) preparing bempedoic acid granules, preferably by the process according to item (178) or item (179), b) mixing bempedoic acid granules with ezetimibe granules and extragranular excipients comprising the extragranular diluent, optionally, the extragranular disintegrant, optionally, the extragranular solubilizing agent optionally, the extragranular glidant, and optionally, the extragranular lubricant, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating.

[0200] (182) Granules comprising bempedoic acid and ezetimibe consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-30 wt.% of microcrystalline cellulose, preferably 15-25 wt.% of microcrystalline cellulose relative to the total weight of the granules, a4) 0.2-2 wt.% of intragranular sodium lauryl sulfate, preferably 0.3-1 wt.% of intragranular sodium lauryl sulfate relative to the total weight of the granules, a5) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose relative to the total weight of the granules, a6) 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate relative to the total weight of the granules.

[0201] (183) A process for preparing the granules according to item (182) comprising the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose in water, b) mixing bempedoic acid, ezetimibe, microcrystalline cellulose, sodium starch glycolate, and sodium lauryl sulfate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules.

[0202] (184) A process for preparing the granules according to item (182) comprising the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose and sodium lauryl sulfate in water, b) mixing bempedoic acid, ezetimibe, microcrystalline cellulose and sodium starch glycolate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules.

[0203] (185) A process for preparing the granules according to item (182) comprising the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving hydroxypropyl cellulose in water, b) mixing bempedoic acid, ezetimibe, microcrystalline cellulose, sodium starch glycolate, and sodium lauryl sulfate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules.

[0204] (186) A process for preparing the granules according to item (182) comprising the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving hydroxypropyl cellulose and sodium lauryl sulfate in water, b) mixing bempedoic acid, ezetimibe, microcrystalline cellulose and sodium starch glycolate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules.

[0205] (187) A tablet comprising granules according to item (182).

[0206] (188) A tablet obtained by the process according to any one of items (125) to (139), or items (178) to (182).

[0207] (189) The tablet according to any one of items (1) to (124), (147), (151) to (164), (167) to (176), (187) or (188), wherein the tablet comprises 180 mg of bempedoic acid and 10 mg ezetimibe.

[0208] (190) The tablet according to any one of items (147) to (150), (154) to (166), or (170) to (176), wherein the tablet comprises 180 mg of bempedoic acid. (191) The tablet according to any one of items (1) to (106), (129 to (159) or (169) to (172), wherein the tablet comprises an additional active ingredient, preferably statin, more preferably atorvastatin, rosuvastatin, pravastatin, simvastatin, lovastatin, fluvastatin or pitavastatin, most preferably atorvastatin or rosuvastatin.

[0209] (192) The tablet according to item (191), wherein the tablet comprises 10-80 mg of atorvastatin, 5- 40 mg of rosuvastatin, 10-40 mg of pravastatin, 10-20 mg of simvastatin, 20-40 mg of lovastatin, 20-80 mg of fluvastatin or 1-4 mg of pitavastatin, most preferably 40-80 mg of atorvastatin or 20-40 mg of rosuvastatin.

[0210] In the above list of items as well as throughout the present specification with its claims and embodiments: the reference to “tablets” in particular refers to tablets comprising a tablet core and optionally a coating. Tablets containing more than one tablet core (and optionally a coating) are also envisaged; a tablet, in the absence of a coating, may also consist of (and be the same as) a tablet core; the wording “bempedoic acid granule(s)” and “granule(s) comprising bempedoic acid” are used in a synonymous manner; the wording “ezetimibe granule(s)” and “granule(s) comprising ezetimibe” are used in a synonymous manner; the reference to “the granules” is as evident from the respective embodiments.

[0211] According to a further aspect of the present invention, the term “tablet” in the above items and throughout the present specification (including the claims) may also be replaced by one of the terms ’’tablet formulation” or “pharmaceutical composition”. The pharmaceutical composition may in particular be a tablet formulation, and it may be in uncompacted (not compressed) or unmolded form, or in compacted (compressed) or molded form of a tablet. Thus, according to one aspect of the invention, the granules and extragranular phases as described herein may be present in a pharmaceutical composition, in particular a tablet formulation, in uncompressed (unmolded) or compressed (molded) form. According to one aspect, the indications of the amounts in the items and embodiments disclosed herein are thus corresponding to the amounts of ingredients / granules / extragranular phases as used in the formulation for a tablet.

[0212] Detailed description of the invention

[0213] The present invention is related to a tablet comprising a combination of bempedoic acid and ezetimibe.

[0214] In some aspects of the present invention, the tablet comprises a coating, for example a coating comprising one or more of polyvinyl alcohol (PVA), glycerol monocaprylocaprate type 1, sodium lauryl sulfate, titanium dioxide and talc.

[0215] Preferably, the tablet of the present invention comprises 180 mg of bempedoic acid and 10 mg ezetimibe.

[0216] The present invention is further related to granules comprising bempedoic acid and ezetimibe. The present invention is further related to bempedoic acid granules and a tablet comprising bempedoic acid granules.

[0217] Preferably, the tablet of the present invention comprises 180 mg of bempedoic acid.

[0218] Preferably, tablets of the present invention are used for the treatment of hypercholesterolaemia and mixed dyslipidaemia and the prevention and treatment of cardiovascular diseases, as e.g. disclosed in WO2018 / 218147A1. The respective disclosure ofWO2018 / 218147Al is explicitly incorporated herein by reference.

[0219] Any known polymorphic form of bempedoic acid or its salt may be used in the tablets of the present invention. Preferably, crystalline bempedoic acid, more preferably bempedoic acid polymorphic form described in IPCOM000254434D or EP 3666750 Al is used in the tablets of the present invention.

[0220] Bempedoic acid may be prepared by any known process, for example processes described in WO 2004 / 067489 Al, WO 2020 / 141419 Al, WO 2020 / 257571 Al.

[0221] Any known polymorphic form of ezetimibe may be used in the tablets of the present invention, for example anhydrous form of ezetimibe Form A, hydrate form of ezetimibe Form B. Preferably, anhydrous form of ezetimibe Form A is used in the tablets of the present invention.

[0222] Nustendi® tablets comprise separate bempedoic acid granules and ezetimibe granules. Consequently, a manufacturing process includes two granulating processes.

[0223] As used herein and in the appended claims, singular articles such as "a," "an" and "the" in the context of describing elements or features (such e.g. diluent, disintegrant, lubricant or other ingredients / excipients) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or logically contradicted by context. Recitation of ranges of values including the upper and lower bounds of the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or logically contradicted by context.

[0224] Surprisingly, it has been found that ezetimibe can be included directly to extragranular phase of the tablet. Consequently, a manufacturing process includes only one granulating process and is simpler and less time-consuming in comparison to a process for preparing Nustendi® tablets. In principle, any known granulate of bempedoic acid may be included in the tablets of the present invention comprising bempedoic acid granules and ezetimibe in an extragranular phase.

[0225] One aspect of the present invention is a tablet (the term “tablet” can be replaced below according to further aspects of the invention by “pharmaceutical composition” or “tablet formulation” as explained above) comprising bempedoic acid granule and ezetimibe in an extragranular phase.

[0226] In some embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) ezetimibe, b2) an extragranular diluent, b3) an extragranular disintegrant, b4) optionally, an extragranular solubilizing agent, b5) optionally, an extragranular glidant, b6) optionally, an extragranular lubricant.

[0227] In some embodiments, the tablet comprises: a) granules comprising: al) bempedoic acid, a2) an intragranular diluent, a3) an intragranular binder, a4) optionally, an intragranular disintegrant, a5) optionally, an intragranular glidant, a6) optionally, an intragranular lubricant, b) extragranular phase comprising: bl) ezetimibe. b2) an extragranular diluent, b3) an extragranular disintegrant, b4) optionally, an extragranular solubilizing agent, b5) optionally, an extragranular glidant, b6) optionally, an extragranular lubricant.

[0228] In some embodiments, the tablet comprises: a) granules consisting of: al) bempedoic acid, a2) an intragranular diluent, a3) an intragranular binder, a4) optionally, an intragranular disintegrant, b) extragranular phase comprising: bl) ezetimibe, b2) an extragranular diluent, b3) an extragranular disintegrant, b4) optionally, an extragranular solubilizing agent, b5) optionally, an extragranular glidant, b6) optionally, an extragranular lubricant.

[0229] Furthermore, in contrary to the teaching of WO 2018 / 218147 it has been surprisingly found that appropriate bempedoic acid granules can be prepared without a lubricant and without a glidant. Such granules can be prepared by less time-consuming process.

[0230] One aspect of the present invention are granules consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of intragranular diluent, preferably 15-25 wt.% of intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of intragranular binder, preferably 2-6 wt.% of intragranular binder, more preferably 3-5 wt.% of intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of intragranular disintegrant, preferably 2-6 wt.% of intragranular disintegrant, more preferably 3-5 wt.% of intragranular disintegrant relative to the total weight of the granules.

[0231] One aspect of the present invention is a tablet comprising granules of the present invention, wherein the tablet comprises bempedoic acid as the only active ingredient, a combination of bempedoic acid and ezetimibe, a combination of bempedoic acid and statin, a combination of bempedoic acid, ezetimibe and statin.

[0232] In some embodiments, the tablet comprises: a) granules consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of intragranular diluent, preferably 15-25 wt.% of intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of intragranular binder, preferably 2-6 wt.% of intragranular binder, more preferably 3-5 wt.% of intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of intragranular disintegrant, preferably 2-6 wt.% of intragranular disintegrant, more preferably 3-5 wt.% of intragranular disintegrant relative to the total weight of the granules, b) extragranular phase comprising: bl) an extragranular diluent, b2) an extragranular disintegrant, b3) optionally, an extragranular glidant, b4) optionally, an extragranular lubricant.

[0233] In some embodiments, the tablet comprises: a) granules comprising: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of intragranular diluent, preferably 15-25 wt.% of intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of intragranular binder, preferably 2-6 wt.% of intragranular binder, more preferably 3-5 wt.% of intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of intragranular disintegrant, preferably 2-6 wt.% of intragranular disintegrant, more preferably 3-5 wt.% of intragranular disintegrant relative to the total weight of the granules, b) extragranular phase comprising: bl) ezetimibe, b2) an extragranular diluent, b3) an extragranular disintegrant, b4) optionally, an extragranular solubilizing agent, b5) optionally, an extragranular glidant, b6) optionally, an extragranular lubricant.

[0234] In some embodiments, the tablet comprises: a) granules consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of intragranular diluent, preferably 15-25 wt.% of intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of intragranular binder, preferably 2-6 wt.% of intragranular binder, more preferably 3-5 wt.% of intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of intragranular disintegrant, preferably 2-6 wt.% of intragranular disintegrant, more preferably 3-5 wt.% of intragranular disintegrant relative to the total weight of the granules, b) granules comprising ezetimibe, c) extragranular phase comprising: cl) an extragranular diluent, c2) an extragranular disintegrant, c3) optionally, an extragranular solubilizing agent, c4) optionally, an extragranular glidant, c5) optionally, an extragranular lubricant.

[0235] Moreover, it has been surprisingly found that ezetimibe can be included in bempedoic acid granules. What means that a manufacturing process includes only one granulating process and is simpler and less time-consuming.

[0236] One aspect of the present invention are granules comprising bempedoic acid and ezetimibe.

[0237] In some embodiments, the granules comprise: al) bempedoic acid, a2) ezetimibe, a3) an intragranular diluent, a4) an intragranular binder, a5) optionally, an intragranular disintegrant, a6) optionally, an intragranular solubilizing agent, a7) optionally, an intragranular glidant, a8) optionally, an intragranular lubricant,

[0238] In some embodiments, the granules are consisting of: al) bempedoic acid, a2) ezetimibe a3) an intragranular diluent, a4) an intragranular binder, a5) optionally, an intragranular disintegrant, a6) optionally, an intragranular solubilizing agent.

[0239] One aspect of the present invention is a tablet comprising granules, wherein granules comprise bempedoic acid and ezetimibe.

[0240] In some embodiments, the tablet comprises: a) granules comprising: al) bempedoic acid, a2) ezetimibe, a3) an intragranular diluent, a4) an intragranular binder, a5) optionally, an intragranular disintegrant, a6) optionally, an intragranular solubilizing agent, a7) optionally, an intragranular glidant, a8) optionally, an intragranular lubricant, b) extragranular phase comprising: bl) an extragranular diluent, b2) an extragranular disintegrant, b3) optionally, an extragranular solubilizing agent, b4) optionally, an extragranular glidant, b5) optionally, an extragranular lubricant.

[0241] In some embodiments, the tablet comprises: a) granules consisting of: al) bempedoic acid, a2) ezetimibe a3) an intragranular diluent, a4) an intragranular binder, a5) optionally, an intragranular disintegrant, a6) optionally, an intragranular solubilizing agent, b) extragranular phase comprising: bl) an extragranular diluent, b2) an extragranular disintegrant, b3) optionally, an extragranular solubilizing agent, b4) optionally, an extragranular glidant, b5) optionally, an extragranular lubricant.

[0242] All above aspects and embodiments are described in detail in the below embodiments.

[0243] In some embodiments, the tablet comprises 40-90 wt.% of bempedoic acid, preferably 50-85 wt.% of bempedoic acid, more preferably 60-85 wt.% of bempedoic acid, even more preferably 60-80 wt.% of bempedoic acid, even more preferably 65-80 wt.% of bempedoic acid, even more preferably 65-75 wt.% of bempedoic acid, most preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules.

[0244] In some embodiments, the tablet comprises 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core.

[0245] In some embodiments, the tablet comprises 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase.

[0246] In some embodiments, the tablet comprises 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules.

[0247] In some embodiments, the tablet comprises 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core. In some embodiments, the tablet comprises 1.5-5 wt.% of intragranular ezetimibe, preferably 2-4 wt.% of intragranular ezetimibe, more preferably 2-3 wt.% of intragranular ezetimibe relative to the total weight of the tablet core.

[0248] In some embodiments, the tablet comprises 1.5-5 wt.% of extragranular ezetimibe, preferably 2-4 wt.% of extragranular ezetimibe, more preferably 2-3 wt.% of extragranular ezetimibe relative to the total weight of the tablet core.

[0249] In some preferred embodiments, the tablet is free of intragranular glidant and lubricant.

[0250] In some preferred embodiments, the tablet is free of intragranular disintegrant.

[0251] In some embodiments, the intragranular diluent is selected from the group consisting of microcrystalline cellulose, mannitol, lactose, lactose monohydrate, lactose anhydrous, sorbitol, starch, sucrose, calcium carbonate, calcium phosphate, calcium sulfate, erythritol, fructose, inulin, isomalt, lactitol, magnesium carbonate, magnesium oxide, maltitol, maltodextrin, maltose, polydextrose, sodium bicarbonate, sodium carbonate, sodium chloride, trehalose, xylitol, cellulose acetate, or a mixture thereof, preferably the intragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol or starch, more preferably microcrystalline cellulose, lactose monohydrate, or a mixture thereof, even more preferably, a mixture of microcrystalline cellulose and lactose monohydrate, most preferably microcrystalline cellulose.

[0252] In some embodiments, the granules comprise 4-50 wt.% of the intragranular diluent, preferably 10-50 wt.% of the intragranular diluent, more preferably 10-40 wt.% of the intragranular diluent, even more preferably 10-30 wt.% of the intragranular diluent, most preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules.

[0253] In some embodiments, the tablet comprises 2-40 wt.% of the intragranular diluent, preferably 5-40 wt.% of the intragranular diluent, more preferably 5-30 wt.% of the intragranular diluent, even more preferably 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core.

[0254] In some embodiments, the granules comprise 4-50 wt.% of intragranular microcrystalline cellulose, preferably 10-50 wt.% of intragranular microcrystalline cellulose, more preferably 10-40 wt.% of intragranular microcrystalline cellulose, even more preferably 10-30 wt.% of intragranular microcrystalline cellulose, most preferably 15-25 wt.% of intragranular microcrystalline cellulose relative to the total weight of the granules.

[0255] In some embodiments, the granules comprise 4-50 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, preferably 10-50 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, more preferably 10-40 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, even more preferably 10-30 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, most preferably 15-25 wt.% of the intragranular mixture of microcrystalline cellulose and lactose relative to the total weight of the granules. Preferably, lactose is lactose monohydrate. In some embodiments, the tablet comprises 2-40 wt.% of intragranular microcrystalline cellulose, preferably 5-40 wt.% of intragranular microcrystalline cellulose, more preferably 5-30 wt.% of intragranular microcrystalline cellulose, even more preferably 5-20 wt.% of intragranular microcrystalline cellulose, most preferably 10-15 wt.% of intragranular microcrystalline cellulose relative to the total weight of the tablet core.

[0256] In some embodiments, the tablet comprises 2-40 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, preferably 5-40 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, more preferably 5-30 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, even more preferably 5-20 wt.% of the intragranular mixture of microcrystalline cellulose and lactose, most preferably 10-15 wt.% of the intragranular mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core. Preferably, lactose is lactose monohydrate.

[0257] In some embodiments, the intragranular binder is selected from hydroxypropyl cellulose, hydroxypropylmethyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxyethylmethyl cellulose, ethyl cellulose, cellulose acetate phthalate, povidone, acacia, agar, alginic acid, calcium carbonate, carboxymethylcellulose sodium, chitosan, crosslinked polyvinylpyrrolidone, com syrup solids, dextrates, dextrin, dextrose, gelatin, guar gum, isomalt, maltitol, maltodextrin, maltose, poloxamer, polydextrose, polyethylene oxide, polymethacrylates, sodium alginate, starch, pregelatinized starch or sucrose, preferably the intragranular binder is hydroxypropyl cellulose, povidone, hydroxypropylmethyl cellulose or crosslinked polyvinylpyrrolidone, more preferably the intragranular binder is hydroxypropyl cellulose.

[0258] In some embodiments, the granules comprise 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 3-5 wt.% of intragranular binder relative to the total weight of the granules.

[0259] In some embodiments, the tablet comprises 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core.

[0260] In some embodiments, the granules comprise 2-8 wt.% of intragranular hydroxypropyl cellulose, preferably 2-6 wt.% of intragranular hydroxypropyl cellulose more preferably 3-5 wt.% of intragranular hydroxypropyl cellulose relative to the total weight of the granules.

[0261] In some embodiments, the tablet comprises 1-8 wt.% of intragranular hydroxypropyl cellulose, preferably 2-6 wt.%, more preferably 2-4 wt.% of intragranular hydroxypropyl cellulose relative to the total weight of the tablet core.

[0262] In some embodiments, the tablet comprises 1-8 wt.% of the intragranular povidone, preferably 2-6 wt.%, more preferably 2-4 wt.% of the intragranular povidone relative to the total weight of the tablet core.

[0263] In some embodiments, the granules comprise 2-8 wt.% of the intragranular povidone, preferably 2-6 wt.% of the intragranular povidone, more preferably 3-5 wt.% of the intragranular povidone relative to the total weight of the granules. In some embodiments, the intragranular disintegrant is selected from sodium starch glycolate, croscarmellose sodium, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone, carboxymethylcellulose calcium, pregelatinized starch, alginic acid, calcium alginate, chitosan, carboxymethylcellulose calcium, guar gum, magnesium aluminium silicate, methylcellulose, povidone, sodium alginate or starch, preferably the intragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium, sodium starch glycolate or low- substituted hydroxypropyl cellulose, more preferably the intragranular disintegrant is sodium starch glycolate.

[0264] In some embodiments, the granules comprise 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 3-5 wt.% of the intragranular disintegrant relative to the total weight of the granules.

[0265] In some embodiments, the tablet comprises 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.%, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core.

[0266] In some embodiments, the granules comprise 2-8 wt.% of intragranular sodium starch glycolate, preferably 2-6 wt.% of intragranular sodium starch glycolate, more preferably 3-5 wt.% of intragranular sodium starch glycolate relative to the total weight of the granules.

[0267] In some embodiments, the tablet comprises 1-8 wt.% of intragranular sodium starch glycolate, preferably 2-6 wt.% of intragranular sodium starch glycolate, more preferably 2-4 wt.% of intragranular sodium starch glycolate relative to the total weight of the tablet core.

[0268] In some embodiments, the intragranular solubilizing agent is selected from sodium lauryl sulfate, benzyl benzoate, benzalkonium chloride, betadex sulfobutyl ether sodium, cetylpyridinium chloride, cyclodextrins, diethylene glycol monoethyl ether, fumaric acid, hydroxypropyl betadex, hypromellose, lanolin alcohols, lecithin, oleic acid, oleyl alcohol, phospholipids, poloxamer, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyoxyl 15 hydroxystearate, polyoxylglycerides, sorbitan esters, sorbitan fatty acid esters, stearic acid, triolein or vitamin E polyethylene glycol succinate, preferably the intragranular solubilizing agent is sodium lauryl sulfate.

[0269] In some embodiments, the tablet comprises 0.3-2 wt.% of the intragranular solubilizing agent, preferably 0.5-1.5 wt.% of the intragranular solubilizing agent relative to the total weight of the granules.

[0270] In some embodiments, the tablet comprises 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the tablet core.

[0271] In some embodiments, the tablet comprises 0.3-2 wt.% of intragranular sodium lauryl sulfate, preferably 0.5-1.5 wt.% of intragranular sodium lauryl sulfate relative to the total weight of the granules. In some embodiments, the tablet comprises 0.2-2 wt.% of intragranular sodium lauryl sulfate, preferably 0.3-1 wt.% of intragranular sodium lauryl sulfate relative to the total weight of the tablet core.

[0272] In some embodiments, the intragranular glidant is selected from silicon dioxide, colloidal silicon dioxide, anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide, hydrophobic colloidal silicon dioxide, talc, magnesium silicate, magnesium trisilicate, tribasic calcium phosphate, powdered cellulose, magnesium oxide, sodium stearate or sodium stearyl fumarate, preferably the intragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, more preferably colloidal silicon dioxide, even more preferably anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide or hydrophobic colloidal silicon dioxide, most preferably anhydrous colloidal silicon dioxide.

[0273] In some embodiments, the granules comprise 0-5 wt.% of the intragranular glidant, preferably 0.5-3 wt.% of the intragranular glidant, more preferably 1-2 wt.% of the intragranular glidant relative to the total weight of the granules.

[0274] In some embodiments, the tablet comprises 0-5 wt.% of the intragranular glidant, preferably 0.5-3 wt.% of the intragranular glidant, more preferably 0.5-2 wt.% of the intragranular glidant relative to the total weight of the tablet core.

[0275] In some embodiments, the granules comprise 0-5 wt.% of intragranular silicon dioxide, preferably 0.5- 3 wt.% of intragranular silicon dioxide, more preferably 1-2 wt.% of intragranular silicon dioxide relative to the total weight of the granules. Preferably, silicon dioxide is colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0276] In some embodiments, the tablet comprises 0-5 wt.% of intragranular silicon dioxide, preferably 0.5-3 wt.% of intragranular silicon dioxide, more preferably 0.5-2 wt.% of intragranular silicon dioxide relative to the total weight of the tablet core. Preferably, silicon dioxide is colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0277] In some embodiments, the intragranular lubricant is selected from magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl monostearate, glyceryl palmitostearate, glyceryl dibehenate, glyceryl behenate, leucine, myristic acid, palmitic acid, poloxamer, polyethylene glycol, potassium benzoate, sodium benzoate, sodium stearate, stearic acid, talc, tribehenin or zinc stearate, preferably the intragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid, more preferably magnesium stearate.

[0278] In some embodiments, the granules comprise 0-5 wt.% of the intragranular lubricant, preferably 0.5-3 wt.% of the intragranular lubricant, more preferably 1-2 wt.% of the intragranular lubricant relative to the total weight of the granules.

[0279] In some embodiments, the tablet comprises 0-5 wt.% of the intragranular lubricant, preferably 0.5-3 wt.% of the intragranular lubricant, more preferably 0.5-2 wt.% of the intragranular lubricant relative to the total weight of the tablet core.

[0280] In some embodiments, the granules comprise 0-5 wt.% of intragranular magnesium stearate, preferably 0.5-3 wt.% of the intragranular magnesium stearate, more preferably 1-2 wt.% of intragranular magnesium stearate relative to the total weight of the granules. In some embodiments, the tablet comprises 0-5 wt.% of intragranular magnesium stearate, preferably 0.5-3 wt.% of intragranular magnesium stearate, more preferably 0.5-2 wt.% of intragranular magnesium stearate relative to the total weight of the tablet core.

[0281] In some embodiments, the extragranular diluent is selected from microcrystalline cellulose, mannitol, lactose monohydrate, lactose anhydrous, sorbitol, starch, sucrose, calcium carbonate, calcium phosphate, calcium sulfate, erythritol, fructose, inulin, isomalt, lactitol, magnesium carbonate, magnesium oxide, maltitol, maltodextrin, maltose, polydextrose, sodium bicarbonate, sodium carbonate, sodium chloride, trehalose, xylitol, cellulose acetate, or a mixture thereof, preferably the extragranular diluent is microcrystalline cellulose, lactose monohydrate, lactose anhydrous, mannitol or starch, more preferably the extragranular diluent is microcrystalline cellulose, lactose or a mixture thereof, even more preferably the extragranular diluent is a mixture of microcrystalline cellulose and lactose, most preferably the extragranular diluent is a mixture of microcrystalline cellulose and lactose monohydrate.

[0282] In some embodiments, the extragranular phase comprises 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 65-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase.

[0283] In some embodiments, the extragranular phase comprises 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core.

[0284] In some embodiments, the extragranular phase comprises 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 65-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, wherein the extragranular diluent is microcrystalline cellulose, lactose or a mixture thereof, preferably a mixture of microcrystalline cellulose and lactose, wherein lactose is preferably lactose monohydrate.

[0285] In some embodiments, the extragranular phase comprises 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent, relative to the total weight of the tablet core, wherein the extragranular diluent is microcrystalline cellulose, lactose or a mixture thereof, preferably a mixture of microcrystalline cellulose and lactose, wherein lactose is preferably lactose monohydrate.

[0286] In some embodiments, the extragranular phase comprises 20-50 wt.% of extragranular microcrystalline cellulose and 20-50 wt.% of extragranular lactose, preferably 25-45 wt.% of extragranular microcrystalline cellulose and 30-50 wt.% of extragranular lactose, more preferably 25- 40 wt.% of extragranular microcrystalline cellulose and 30-45 wt.% of extragranular lactose relative to the total weight of the extragranular phase, wherein lactose is preferably lactose monohydrate.

[0287] In some embodiments, the extragranular phase comprises 5-30 wt.% of extragranular microcrystalline cellulose and 5-30 wt.% of extragranular lactose, preferably 5-20 wt.% of extragranular microcrystalline cellulose and 5-25 wt.% of extragranular lactose, more preferably 10-20 wt.% of extragranular microcrystalline cellulose and 10-25 wt.% of extragranular lactose, even more preferably 10-15 wt.% of extragranular microcrystalline cellulose and 10-15 wt.% of extragranular lactose relative to the total weight of the tablet core, wherein lactose is preferably lactose monohydrate.

[0288] In some embodiments, the extragranular disintegrant is selected from sodium starch glycolate, croscarmellose sodium, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone, carboxymethylcellulose calcium, pregelatinized starch, alginic acid, calcium alginate, chitosan, carboxymethylcellulose calcium, guar gum, magnesium aluminium silicate, methylcellulose, povidone, sodium alginate or starch, preferably the extragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium, sodium starch glycolate or low- substituted hydroxypropyl cellulose, more preferably the extragranular disintegrant is sodium starch glycolate.

[0289] In some embodiments, the extragranular phase comprise 5-15 wt.% of the extragranular disintegrant, preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase.

[0290] In some embodiments, the tablet comprises 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core.

[0291] In some embodiments, the extragranular phase comprise 5-15 wt.% of extragranular sodium starch glycolate, preferably 8-14 wt.% of extragranular sodium starch glycolate relative to the total weight of the extragranular phase.

[0292] In some embodiments, the tablet comprises 2-10 wt.% of extragranular sodium starch glycolate, preferably 3-8 wt.% of extragranular sodium starch glycolate, more preferably 6-8 wt.% of extragranular sodium starch glycolate, most preferably 3-6 wt.% of extragranular sodium starch glycolate relative to the total weight of the tablet core.

[0293] In some embodiments, the extragranular solubilizing agent is selected from sodium lauryl sulfate, benzyl benzoate, benzalkonium chloride, betadex sulfobutyl ether sodium, cetylpyridinium chloride, cyclodextrins, diethylene glycol monoethyl ether, fumaric acid, hydroxypropyl betadex, hypromellose, lanolin alcohols, lecithin, oleic acid, oleyl alcohol, phospholipids, poloxamer, polyoxyethylene alkyl ethers, polyoxyethylene castor oil derivatives, polyoxyethylene sorbitan fatty acid esters, polyoxyl 15 hydroxystearate, polyoxylglycerides, sorbitan esters, sorbitan fatty acid esters, stearic acid, triolein or vitamin E polyethylene glycol succinate, preferably the extragranular solubilizing agent is sodium lauryl sulfate.

[0294] In some embodiments, the tablet comprises 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase.

[0295] In some embodiments, the tablet comprises 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core. In some embodiments, the tablet comprises 0.5-3 wt.% of extragranular sodium lauryl sulfate, preferably 1-2 wt.% of extragranular sodium lauryl sulfate relative to the total weight of the extragranular phase.

[0296] In some embodiments, the tablet comprises 0.2-2 wt.% of extragranular sodium lauryl sulfate, preferably 0.3-1 wt.% of extragranular sodium lauryl sulfate relative to the total weight of the tablet core.

[0297] In some embodiments, the extragranular glidant is selected from silicon dioxide, colloidal silicon dioxide, anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide, hydrophobic colloidal silicon dioxide, talc, magnesium silicate, magnesium trisilicate, tribasic calcium phosphate, powdered cellulose, magnesium oxide, sodium stearate or sodium stearyl fumarate, preferably the extragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, more preferably colloidal silicon dioxide, even more preferably anhydrous colloidal silicon dioxide, hydrated colloidal silicon dioxide or hydrophobic colloidal silicon dioxide, most preferably anhydrous colloidal silicon dioxide.

[0298] In some embodiments, the extragranular phase comprise 0.2-6 wt.% of the extragranular glidant, preferably 1-6 wt.% of the extragranular glidant or 0.2-1 wt.% of the extragranular glidant, more preferably 0.2-0.5 wt.% of the extragranular glidant, most preferably 1-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase.

[0299] In some embodiments, the tablet comprises 0.1-3 wt.% of the extragranular glidant, preferably 0.3-2 wt.% of the extragranular glidant or 0.1-1 wt.% of the extragranular glidant, more preferably 0.1-0.5 wt.% of the extragranular glidant, even more preferably 0.1-0.3 wt.% of the extragranular glidant, most, more preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core.

[0300] In some embodiments, the extragranular phase comprise 0.2-6 wt.% of extragranular silicon dioxide, preferably 1-6 wt.% of extragranular silicon dioxide or 0.2-1 wt.% of extragranular silicon dioxide, more preferably 0.2-0.5 wt.% of extragranular silicon dioxide, most preferably 1-4 wt.% of extragranular silicon dioxide relative to the total weight of the extragranular phase. Preferably, silicon dioxide is colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0301] In some embodiments, the tablet comprises 0.1-3 wt.% of extragranular silicon dioxide, preferably 0.3-2 wt.% of extragranular silicon dioxide or 0.1-1 wt.% of extragranular silicon dioxide, more preferably 0.1-0.5 wt.% of extragranular silicon dioxide, even more preferably 0.1-0.3 wt.% of extragranular silicon dioxide, most, preferably 0.5-2 wt.% of extragranular silicon dioxide relative to the total weight of the tablet core. Preferably, silicon dioxide is colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide.

[0302] In some embodiments, the extragranular lubricant is selected from magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, glyceryl monostearate, glyceryl palmitostearate, glyceryl dibehenate, glyceryl behenate, leucine, myristic acid, palmitic acid, poloxamer, polyethylene glycol, potassium benzoate, sodium benzoate, sodium stearate, stearic acid, talc, tribehenin or zinc stearate, preferably the extragranular lubricant is magnesium stearate, sodium stearyl fumarate or talc, more preferably magnesium stearate or sodium stearyl fumarate, most preferably magnesium stearate. In some embodiments, the extragranular phase comprise 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0303] In some embodiments, the tablet comprises 0-5 wt.% of the extragranular lubricant, preferably 0.5-5 wt.% of the extragranular lubricant, more preferably 1-4 wt.% of the extragranular lubricant, even more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0304] In some embodiments, the extragranular phase comprise 1-15 wt.% of extragranular magnesium stearate, preferably 1-5 wt.% of extragranular magnesium stearate, more preferably 5-10 wt.% of extragranular magnesium stearate relative to the total weight of the extragranular phase.

[0305] In some embodiments, the tablet comprises 0-5 wt.% of extragranular magnesium stearate, preferably 0.5-5 wt.% of extragranular magnesium stearate, more preferably 1-4 wt.% of extragranular magnesium stearate, even more preferably 1-2 wt.% of extragranular magnesium stearate, most preferably 2-4 wt.% of extragranular magnesium stearate relative to the total weight of the tablet core.

[0306] In some embodiments, the tablet comprises: a) 45-70 wt.% of the granules comprising bempedoic acid, preferably 50-70 wt.% of the granules comprising bempedoic acid, more preferably 55-65 wt.% of the granules comprising bempedoic acid relative to the total weight of the tablet core, b) 30-55 wt.% of the extragranular phase, preferably 30-50 wt.% of the extragranular phase, more preferably 35-45 wt.% of the extragranular phase relative to the total weight of the tablet core.

[0307] In some embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 65-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase, b5) optionally, 1-6 wt.% of the extragranular glidant, preferably 1-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0308] In some preferred embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0309] In some embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 65-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase, b5) optionally, 0.2-6 wt.% of the extragranular glidant, preferably 0.2-1 wt.% of the extragranular glidant, more preferably 0.2-0.5 wt.% of the extragranular glidant relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0310] In some preferred embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.1-2 wt.% of the extragranular glidant, preferably 0. 1-0.3 wt.% of the extragranular glidant, more preferably 0.1-0.2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant of the extragranular lubricant relative to the total weight of the tablet core.

[0311] In some embodiments, the tablet comprises: a) 45-70 wt.% of the granules comprising bempedoic acid, preferably 50-70 wt.% of the granules comprising bempedoic acid, more preferably 55-65 wt.% of the granules comprising bempedoic acid relative to the total weight of the tablet core, b) 30-55 wt.% of the extragranular phase, preferably 30-50 wt.% of the extragranular phase, more preferably 35-45 wt.% of the extragranular phase relative to the total weight of the tablet core, wherein the extragranular phase comprises: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably 65-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase, b5) optionally, 1-6 wt.% of the extragranular glidant, preferably 1-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0312] In some preferred embodiments, the tablet comprises: a) 45-70 wt.% of the granules comprising bempedoic acid, preferably 50-70 wt.% of the granules comprising bempedoic acid, more preferably 55-65 wt.% of the granules comprising bempedoic acid relative to the total weight of the tablet core, b) 30-55 wt.% of the extragranular phase, preferably 30-50 wt.% of the extragranular phase, more preferably 35-45 wt.% of the extragranular phase relative to the total weight of the tablet core, wherein the extragranular phase comprises: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0313] In some preferred embodiments, the extragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the extragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the extragranular solubilizing agent is sodium lauryl sulfate, the extragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the extragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid.

[0314] In some more preferred embodiments, the extragranular diluent is a mixture of microcrystalline cellulose and lactose, preferably a mixture of microcrystalline cellulose and lactose monohydrate, the extragranular disintegrant is sodium starch glycolate, the extragranular solubilizing agent is sodium lauryl sulfate, the extragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the extragranular lubricant is magnesium stearate or sodium stearyl fumarate; preferably magnesium stearate.

[0315] In some embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 40-85 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 50-80 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 60-80 wt.% of the mixture of microcrystalline cellulose and lactose, most preferably 65-75 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of sodium lauryl sulfate, preferably 1-2 wt.% of sodium lauryl sulfate relative to the total weight of the extragranular phase, b5) optionally, 1-6 wt.% of colloidal silicon dioxide, preferably 1-4 wt.% of colloidal silicon dioxide relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of magnesium stearate or sodium stearyl fumarate, preferably 1-5 wt.% of magnesium stearate or sodium stearyl fumarate, more preferably 5-10 wt.% of magnesium stearate or sodium stearyl fumarate relative to the total weight of the extragranular phase.

[0316] In some embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 20-50 wt.% of extragranular microcrystalline cellulose and 20-50 wt.% of extragranular lactose, preferably 25-45 wt.% of extragranular microcrystalline cellulose and 30-50 wt.% of extragranular lactose, more preferably 25-40 wt.% of extragranular microcrystalline cellulose and 30-45 wt.% of extragranular lactose relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of sodium lauryl sulfate, preferably 1-2 wt.% of sodium lauryl sulfate relative to the total weight of the extragranular phase, b5) optionally, 1-6 wt.% of colloidal silicon dioxide, preferably 1-4 wt.% of colloidal silicon dioxide relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of magnesium stearate or sodium stearyl fumarate, preferably 1-5 wt.% of magnesium stearate or sodium stearyl fumarate, more preferably 5-10 wt.% of magnesium stearate or sodium stearyl fumarate relative to the total weight of the extragranular phase.

[0317] In some embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 40-85 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 50-80 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 60-80 wt.% of the mixture of microcrystalline cellulose and lactose, most preferably 65-75 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of sodium lauryl sulfate, preferably 1-2 wt.% of sodium lauryl sulfate relative to the total weight of the extragranular phase, b5) optionally, 0.2-6 wt.% of colloidal silicon dioxide, preferably 0.2-1 wt.% of colloidal silicon dioxide, more preferably 0.2-0.5 wt.% of colloidal silicon dioxide relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of magnesium stearate or sodium stearyl fumarate, preferably 1-5 wt.% of magnesium stearate or sodium stearyl fumarate relative to the total weight of the extragranular phase.

[0318] In some embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 20-50 wt.% of extragranular microcrystalline cellulose and 20-50 wt.% of extragranular lactose, preferably 25-45 wt.% of extragranular microcrystalline cellulose and 30-50 wt.% of extragranular lactose, more preferably 25-40 wt.% of extragranular microcrystalline cellulose and 30-45 wt.% of extragranular lactose relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of sodium lauryl sulfate, preferably 1-2 wt.% of sodium lauryl sulfate relative to the total weight of the extragranular phase, b5) optionally, 0.1-2 wt.% of colloidal silicon dioxide, preferably 0.1-0.3 wt.% of colloidal silicon dioxide, more preferably 0.1-0.2 wt.% of colloidal silicon dioxide relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of magnesium stearate, preferably 1-5 wt.% of magnesium stearate or sodium stearyl fumarate, more preferably 5-10 wt.% of magnesium stearate or sodium stearyl fumarate relative to the total weight of the extragranular phase.

[0319] In some embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 5-8 wt.% of ezetimibe, preferably 6-7 wt.% of ezetimibe relative to the extragranular phase, b2) 25-40 wt.% of extragranular microcrystalline cellulose and 30-45 wt.% of extragranular lactose relative to the total weight of the extragranular phase, b3) 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 1-2 wt.% of sodium lauryl sulfate relative to the total weight of the extragranular phase, b5) optionally, 1-4 wt.% of colloidal silicon dioxide relative to the total weight of the extragranular phase, b6) optionally, 5-10 wt.% of magnesium stearate relative to the total weight of the extragranular phase.

[0320] In some preferred embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 10-40 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 15-35 wt.% of the mixture of microcrystalline cellulose and lactose, even more preferably 30-40 wt.% of the mixture of microcrystalline cellulose and lactose, even more preferably 20-30 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, b3) 2-10 wt.% of sodium starch glycolate, preferably 3-8 wt.% of sodium starch glycolate, more preferably 6-8 wt.% of sodium starch glycolate, most preferably 3-6 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b4) 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of colloidal silicon dioxide, preferably 0.5-2 wt.% of colloidal silicon dioxide relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 1-2 wt.% of magnesium stearate, most preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0321] In some preferred embodiments, the tablet comprises: a) granules comprising bempedoic acid, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 5-30 wt.% of extragranular microcrystalline cellulose and 5-30 wt.% of extragranular lactose, preferably 5-20 wt.% of extragranular microcrystalline cellulose and 5-25 wt.% of extragranular lactose, more preferably 10-20 wt.% of extragranular microcrystalline cellulose and 10-25 wt.% of extragranular lactose, even more preferably 10-15 wt.% of extragranular microcrystalline cellulose and 10-15 wt.% of extragranular lactose relative to the total weight of the tablet core, b3) 2-10 wt.% of sodium starch glycolate, preferably 3-8 wt.% of sodium starch glycolate, more preferably 6-8 wt.% of sodium starch glycolate, most preferably 3-6 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b4) 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of colloidal silicon dioxide, preferably 0.5-2 wt.% of colloidal silicon dioxide relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 1-2 wt.% of magnesium stearate, most preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0322] In some embodiments, the tablet comprises: a) granules comprising: al) 40-90 wt.% of bempedoic acid, preferably 50-85 wt.% of bempedoic acid, more preferably 60-85 wt.% of bempedoic acid, even more preferably 60-80 wt.% of bempedoic acid, even more preferably 65-80 wt.% of bempedoic acid, even more preferably 65-75 wt.% of bempedoic acid, most preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 4-50 wt.% of the intragranular diluent, preferably 10-50 wt.% of the intragranular diluent, more preferably 10-40 wt.% of the intragranular diluent, even more preferably 10-30 wt.% of the intragranular diluent, most preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 3-5 wt.% of the intragranular disintegrant relative to the total weight of the granules, a5) optionally, 0.5-3 wt.% of the intragranular glidant, preferably 1-2 wt.% of the intragranular glidant relative to the total weight of the granules, a6) optionally, 0.5-3 wt.% of the intragranular lubricant, preferably 1-2 wt.% of the intragranular lubricant relative to the total weight of the granules, b) extragranular phase relative to the total weight of the tablet core comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0323] In some embodiments, the tablet comprises: a) granules comprising: al) 60-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid, most preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 4-50 wt.% of the intragranular diluent, preferably 10-50 wt.% of the intragranular diluent, more preferably 10-40 wt.% of the intragranular diluent, even more preferably 10-30 wt.% of the intragranular diluent, most preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative, more preferably 2-6 wt.% of the intragranular binder to the total weight of the granules, a4) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules, a5) optionally, 0.5-3 wt.% of the intragranular glidant, preferably 1-2 wt.% of the intragranular glidant relative to the total weight of the granules, a6) optionally, 0.5-3 wt.% of the intragranular lubricant, preferably 1-2 wt.% of the intragranular lubricant relative to the total weight of the granules, b) extragranular phase relative to the total weight of the tablet core comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0324] In some preferred embodiments, the tablet comprises: a) granules comprising: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-40 wt.% of the intragranular diluent, preferably 5-30 wt.% of the intragranular diluent, more preferably 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, a5) optionally, 0.5-3 wt.% of the intragranular glidant, more preferably 0.5-2 wt.% of the intragranular glidant relative to the total weight of the tablet core, a6) optionally, 0.5-3 wt.% of the intragranular lubricant, more preferably 0.5-2 wt.% of the intragranular lubricant relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0325] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-40 wt.% of the intragranular diluent, preferably 5-30 wt.% of the intragranular diluent, more preferably 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0326] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-40 wt.% of the intragranular diluent, preferably 5-30 wt.% of the intragranular diluent, more preferably 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0327] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 70-90 wt.% of bempedoic acid, preferably 80-90 wt.% of bempedoic acid, more preferably 85-90% of bempedoic acid relative to the total weight of the granules, a2) 4-20 wt.% of the intragranular diluent, preferably 4-10 wt.% of the intragranular diluent, more preferably 4-6 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 3-6 wt.% of the intragranular binder of the intragranular binder relative to the total weight of the granules, a4) 0.5-3 wt.% of the intragranular glidant or lubricant, more preferably 0.5-2 wt.% of the intragranular glidant or lubricant, more preferably 0.5-1 wt.% of the intragranular glidant or lubricant relative to the total weight of the granules, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0328] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 70-90 wt.% of bempedoic acid, preferably 80-90 wt.% of bempedoic acid, more preferably 85-90% of bempedoic acid relative to the total weight of the granules, a2) 4-20 wt.% of the intragranular diluent, preferably 4-10 wt.% of the intragranular diluent, more preferably 4-6 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 3-6 wt.% of the intragranular binder of the intragranular binder relative to the total weight of the granules, a4) 0.5-3 wt.% of the intragranular glidant or lubricant, more preferably 0.5-2 wt.% of the intragranular glidant or lubricant, more preferably 0.5-1 wt.% of the intragranular glidant or lubricant relative to the total weight of the granules, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) 0.1-2 wt.% of the extragranular glidant, preferably 0. 1-0.3 wt.% of the extragranular glidant, more preferably 0. 1-0.2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant, most preferably 1-2 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0329] In some preferred embodiments, the intragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the intragranular binder is povidone or hydroxypropylmethyl cellulose, the intragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the intragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the intragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid, the extragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the extragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the extragranular solubilizing agent is sodium lauryl sulfate, the extragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the extragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid.

[0330] In some more preferred embodiments, the intragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, more preferably microcrystalline cellulose, the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose, the intragranular disintegrant is sodium starch glycolate, the intragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the intragranular lubricant is magnesium stearate, the extragranular diluent is a mixture of microcrystalline cellulose and lactose, preferably a mixture of microcrystalline cellulose and lactose monohydrate, the extragranular disintegrant is sodium starch glycolate, the extragranular solubilizing agent is sodium lauryl sulfate, the extragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the extragranular lubricant is magnesium stearate.

[0331] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-40 wt.% of microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably 5-30 wt.% of microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, more preferably 5-20 wt.% of microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, most preferably 10-15 wt.% of microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 5-30 wt.% of microcrystalline, preferably 5-20 wt.% of microcrystalline cellulose, more preferably 10-20 wt.% of microcrystalline cellulose, most preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, b3) 5-30 wt.% of lactose, preferably 5-25 wt.% of lactose, more preferably 10-25 wt.% of lactose, 10-15 wt.% of extragranular lactose relative to the total weight of the tablet core, b4) 2-10 wt.% of sodium starch glycolate, preferably 3-8 wt.% of sodium starch glycolate, more preferably 6-8 wt.% of sodium starch glycolate, most preferably 3-6 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b5) 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b6) optionally, 0.3-2 wt.% of colloidal silicon dioxide, preferably 0.5-2 wt.% of colloidal silicon dioxide relative to the total weight of the tablet core, b7) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 1-2 wt.% of magnesium stearate, most preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0332] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 40-50% of bempedoic acid, preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably 10-15 wt.% of microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, preferably microcrystalline cellulose a3) 2-6 wt.% of hydroxypropyl cellulose, preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of sodium starch glycolate, preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 2-4 wt.% of ezetimibe, preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, b3) 10-25 wt.% of lactose, preferably 10-15 wt.% of extragranular lactose relative to the total weight of the tablet core, b4) 3-8 wt.% of sodium starch glycolate, preferably 3-6 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b5) 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b6) optionally, 0.3-2 wt.% of colloidal silicon dioxide, preferably 0.5-2 wt.% of colloidal silicon dioxide relative to the total weight of the tablet core, b7) optionally, 1-4 wt.% of magnesium stearate, preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0333] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 70-90 wt.% of bempedoic acid, preferably 80-90 wt.% of bempedoic acid, more preferably 85-90% of bempedoic acid relative to the total weight of the granules, a2) 4-20 wt.% of microcrystalline cellulose, preferably 4-10 wt.% of microcrystalline cellulose, more preferably 4-6 wt.% of microcrystalline cellulose relative to the total weight of the granules, a3) 2-8 wt.% of hydroxypropyl cellulose, preferably 3-6 wt.% of hydroxypropyl cellulose of hydroxypropyl cellulose relative to the total weight of the granules, a4) 0.5-3 wt.% of colloidal silicon dioxide, more preferably 0.5-2 wt.% of colloidal silicon dioxide, more preferably 0.5-1 wt.% of colloidal silicon dioxide relative to the total weight of the granules, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 5-30 wt.% of microcrystalline, preferably 5-20 wt.% of microcrystalline cellulose, more preferably 10-20 wt.% of microcrystalline cellulose, most preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, b3) 5-30 wt.% of lactose, preferably 5-25 wt.% of lactose, more preferably 10-25 wt.% of lactose, 10-15 wt.% of extragranular lactose, relative to the total weight of the tablet core, b4) 2-10 wt.% of sodium starch glycolate, preferably 3-8 wt.% of sodium starch glycolate, more preferably 6-8 wt.% of sodium starch glycolate, most preferably 3-6 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b5) 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b6) optionally, 0.3-2 wt.% of colloidal silicon dioxide, preferably 0.5-2 wt.% of colloidal silicon dioxide relative to the total weight of the tablet core, b7) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 1-2 wt.% of magnesium stearate, most preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0334] In some preferred embodiments, the granules are consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 3-5 wt.% of intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 3-5 wt.% of intragranular relative to the total weight of the granules.

[0335] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent relative to the total weight of the granules, a3) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 3-5 wt.% of intragranular binder relative to the total weight of the granules, a4) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 3-5 wt.% of intragranular relative to the total weight of the granules.

[0336] In some preferred embodiments, the granules are consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid or 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core.

[0337] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid or 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core.

[0338] In some preferred embodiments, the intragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the intragranular binder is hydroxypropyl cellulose, povidone or hydroxypropylmethyl cellulose , the intragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose.

[0339] In some more preferred embodiments, the intragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, more preferably microcrystalline cellulose, the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose, the intragranular disintegrant is sodium starch glycolate. In some preferred embodiments, the granules are consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-50 wt.% of microcrystalline cellulose, preferably 10-40 wt.% of microcrystalline cellulose, more preferably 10-30 wt.% of microcrystalline cellulose, most preferably 15- 25 wt.% of microcrystalline cellulose relative to the total weight of the granules, a3) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 3-5 wt.% of hydroxypropyl cellulose relative to the total weight of the granules, a4) optionally, 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 3-5 wt.% of sodium starch glycolate relative to the total weight of the granules.

[0340] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-30 wt.% of microcrystalline cellulose, preferably 15-25 wt.% of microcrystalline cellulose relative to the total weight of the granules, a3) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 3-5 wt.% of hydroxypropyl cellulose relative to the total weight of the granules a4) optionally, 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 3-5 wt.% of sodium starch glycolate relative to the total weight of the granules.

[0341] In some preferred embodiments, the granules are consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core.

[0342] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core.

[0343] In some preferred embodiments, the granules are consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core.

[0344] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core.

[0345] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, b2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of the extragranular lubricant, , preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0346] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, b2) 2-10 wt.% of the extragranular disintegrant, preferably 4-8 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1 wt.% of the extragranular glidant relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 0.5-2 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0347] In some preferred embodiments, the intragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the intragranular binder is hydroxypropyl cellulose, povidone or hydroxypropylmethyl cellulose, the intragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the intragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the intragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid, the extragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the extragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the extragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the extragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid.

[0348] In some more preferred embodiments, the intragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, more preferably microcrystalline cellulose, the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose, the intragranular disintegrant is sodium starch glycolate, the intragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the intragranular lubricant is magnesium stearate, the extragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, more preferably microcrystalline cellulose the extragranular disintegrant is sodium starch glycolate, the extragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the extragranular lubricant is magnesium stearate.

[0349] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 5-30 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 10-25 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 15-20 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, b2) 2-10 wt.% of sodium starch glycolate, preferably 4-8 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b3) optionally, 0.1-2 wt.% of colloidal silicone dioxide, preferably 0.1-1 wt.% of colloidal silicone dioxide relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of magnesium stearate, preferably 0.5-2 wt.% of magnesium stearate, more preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0350] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, most preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, b2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0351] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 5-30 wt.% of microcrystalline cellulose, preferably 10-25 wt.% of microcrystalline cellulose, more preferably 15-20 wt.% microcrystalline cellulose relative to the total weight of the tablet core, b2) 2-10 wt.% of sodium starch glycolate, preferably 4-8 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b3) optionally, 0.1-2 wt.% of colloidal silicone dioxide, preferably 0.1-1.5 wt.% of colloidal silicone dioxide, more preferably 0.5-1.5 wt.% of colloidal silicone dioxide relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0352] In some preferred embodiments, the tablet comprises 50-75 wt.% of granules, preferably 55-70 wt.% of granules, more preferably 60-65 wt.% of granules relative to the total weight of the tablet core. In some preferred embodiments, the tablet comprises 75-85 wt.% of granules, preferably 80-85 wt.% of granules relative to the total weight of the tablet core.

[0353] In some more preferred embodiments, the tablet comprises 50-90 wt.% of bempedoic acid granules, preferably 55-80 wt.% of bempedoic acid granules, more preferably 60-75 wt.% of bempedoic acid granules, most preferably 65-75 wt.% of bempedoic acid granules relative to the total weight of the tablet core.

[0354] In some preferred embodiments, the tablet comprises: a) 50-90 wt.% of bempedoic acid granules, preferably 55-80 wt.% of bempedoic acid granules, more preferably 60-75 wt.% of bempedoic acid granules, most preferably 65-75 wt.% of bempedoic acid granules relative to the total weight of the tablet core, wherein bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) 10-50 wt.% of the extragranular phase, preferably 20-45 wt.% of the extragranular phase, preferably 25-40 wt.% of the extragranular phase, most preferably 25-35 wt.% of the extragranular phase relative to the total weight of the tablet core, wherein the extragranular phase comprises: bl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, b2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0355] In some preferred embodiments, the tablet comprises: a) 50-90 wt.% of bempedoic acid granules, preferably 55-80 wt.% of bempedoic acid granules, more preferably 60-75 wt.% of bempedoic acid granules, most preferably 65-75 wt.% of bempedoic acid granules relative to the total weight of the tablet core, wherein bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, most preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 1-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) 10-50 wt.% of the extragranular phase, preferably 20-45 wt.% of the extragranular phase, preferably 25-40 wt.% of the extragranular phase, most preferably 25-35 wt.% of the extragranular phase relative to the total weight of the tablet core, wherein the extragranular phase comprises: bl) 5-30 wt.% of microcrystalline cellulose, preferably 10-25 wt.% of microcrystalline cellulose, more preferably 15-20 wt.% of microcrystalline cellulose, relative to the total weight of the tablet core, b2) 1-10 wt.% of sodium starch glycolate, preferably 2-8 wt.% of sodium starch glycolate, more preferably 2-6 wt.% of sodium starch glycolate, most preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b3) optionally, comprises 0.1-2 wt.% of colloidal silicone dioxide, preferably 0.1-1.5 wt.% of colloidal silicone dioxide, more preferably 0.5-1.5 wt.% of colloidal silicone dioxide relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0356] In some preferred embodiments, the granules are consisting of: al) 65-70 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-15 wt.% of microcrystalline cellulose relative to the total weight of the granules, a3) 10-15 wt.% of lactose relative to the total weight of the granules, a4) 3-4 wt.% of hydroxypropyl cellulose or povidone, relative to the total weight of the granules, a5) 3-4 wt.% of sodium starch glycolate relative to the total weight of the granules.

[0357] In some preferred embodiments, the granules are consisting of: al) 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 8-12 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 8-12 wt.% of lactose relative to the total weight of the tablet core, a4) 2-3 wt.% of hydroxypropyl cellulose or povidone relative to the total weight of the tablet core, a5) 2-3 wt.% of sodium starch glycolate relative to the total weight of the tablet core.

[0358] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 65-70 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-15 wt.% of microcrystalline cellulose relative to the total weight of the granules, a3) 10-15 wt.% of lactose relative to the total weight of the granules, a4) 3-4 wt.% of hydroxypropyl cellulose or povidone, relative to the total weight of the granules, a5) 3-4 wt.% of sodium starch glycolate relative to the total weight of the granules, b) extragranular phase comprising: bl) 13-17 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, b2) 2-3 wt.% of sodium starch glycolate, b3) 0.5-1.5 wt.% of colloidal silicone dioxide relative to the total weight of the tablet core, b4) 3-5 wt.% of magnesium stearate, preferably 4-5 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0359] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 8-12 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 8-12 wt.% of lactose relative to the total weight of the tablet core, a4) 2-3 wt.% of hydroxypropyl cellulose or povidone relative to the total weight of the tablet core, a5) 2-3 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 13-17 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, b2) 2-3 wt.% of sodium starch glycolate, b3) 0.5-1.5 wt.% of colloidal silicone dioxide relative to the total weight of the tablet core, b4) 3-5 wt.% of magnesium stearate, preferably 4-5 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0360] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 65-70 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-15 wt.% of microcrystalline cellulose relative to the total weight of the granules, a3) 10-15 wt.% of lactose relative to the total weight of the granules, a4) 3-4 wt.% of hydroxypropyl cellulose or povidone, relative to the total weight of the granules, a5) 3-4 wt.% of sodium starch glycolate relative to the total weight of the granules, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 10-40 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 15-35 wt.% of the mixture of microcrystalline cellulose and lactose, even more preferably 30-40 wt.% of the mixture of microcrystalline cellulose and lactose, even more preferably 20-30 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, b3) 2-10 wt.% of sodium starch glycolate, preferably 3-8 wt.% of sodium starch glycolate, more preferably 6-8 wt.% of sodium starch glycolate, most preferably 3-6 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b4) 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of colloidal silicon dioxide, preferably 0.5-2 wt.% of colloidal silicon dioxide relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 1-2 wt.% of magnesium stearate, most preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0361] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 8-12 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 8-12 wt.% of lactose relative to the total weight of the tablet core, a4) 2-3 wt.% of hydroxypropyl cellulose or povidone relative to the total weight of the tablet core, a5) 2-3 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 10-40 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 15-35 wt.% of the mixture of microcrystalline cellulose and lactose, even more preferably 30- 40 wt.% of the mixture of microcrystalline cellulose and lactose, even more preferably 20-30 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, b3) 2-10 wt.% of sodium starch glycolate, preferably 3-8 wt.% of sodium starch glycolate, more preferably 6-8 wt.% of sodium starch glycolate, most preferably 3-6 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b4) 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of colloidal silicon dioxide, preferably 0.5-2 wt.% of colloidal silicon dioxide relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 1-2 wt.% of magnesium stearate, most preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0362] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) granules comprising ezetimibe.

[0363] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) granules comprising ezetimibe.

[0364] In some preferred embodiments, the tablet comprises: a) 50-75 wt.% of granules, preferably 55-70 wt.% of granules, more preferably 60-65 wt.% of granules relative to the total weight of the tablet core, wherein the granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) 15-25 wt.% of the granules comprising ezetimibe relative to the total weight of the tablet core.

[0365] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) granules comprising ezetimibe, c) extragranular phase comprising: cl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, c2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, c4) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of the extragranular lubricant, , preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0366] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) 15-25 wt.% of the granules comprising ezetimibe relative to the total weight of the tablet core, c) extragranular phase comprising: cl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, c2) optionally, 2-10 wt.% of the extragranular disintegrant, preferably 4-8 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, c3) optionally, 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1 wt.% of the extragranular glidant relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 0.5-2 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0367] In some preferred embodiments, the tablet comprises: a) 50-75 wt.% of granules, preferably 55-70 wt.% of granules, more preferably 60-65 wt.% of granules relative to the total weight of the tablet core, wherein the granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) 15-25 wt.% of granules comprising ezetimibe relative to the total weight of the tablet core, c) 10-25 wt.% extragranular phase comprising: cl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, c2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, c3) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0368] In some preferred embodiments, the intragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the intragranular binder is povidone or hydroxypropylmethyl cellulose, the intragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the intragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the intragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid, the extragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the extragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the extragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the extragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid.

[0369] In some more preferred embodiments, the intragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, more preferably microcrystalline cellulose, the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose, the intragranular disintegrant is sodium starch glycolate, the intragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the intragranular lubricant is magnesium stearate, the extragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably a mixture of microcrystalline cellulose and lactose, more preferably a mixture of microcrystalline cellulose and lactose monohydrate, the extragranular disintegrant is sodium starch glycolate, the extragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the extragranular lubricant is magnesium stearate.

[0370] In some embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) granules comprising ezetimibe.

[0371] In some embodiments, the tablet comprises: a) 50-75 wt.% of granules, preferably 55-70 wt.% of granules, more preferably 60-65 wt.% of granules relative to the total weight of the tablet core, wherein the granules are consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) 15-25 wt.% of granules comprising ezetimibe relative to the total weight of the tablet core.

[0372] In some embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) granules comprising ezetimibe, c) extragranular phase comprising: cl) 5-30 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 10-25 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 15-20 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, c2) 1-10 wt.% of sodium starch glycolate, preferably 2-8 wt.% of sodium starch glycolate, more preferably 2-6 wt.% of sodium starch glycolate, most preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, c3) optionally, 0.1-2 wt.% of colloidal silicone dioxide, preferably 0.1-1.5 wt.% of colloidal silicone dioxide, preferably 0.5-1.5 of colloidal silicone dioxide relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core. In some embodiments, the tablet comprises: a) granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) 15-25 wt.% of granules comprising ezetimibe relative to the total weight of the tablet core, c) extragranular phase comprising: cl) 5-30 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 10-25 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 15-20 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the tablet core, c2) 2-10 wt.% of sodium starch glycolate, preferably 4-8 wt.% of sodium starch glycolate relative to the total weight of the tablet core, c3) optionally, 0.1-2 wt.% of colloidal silicone dioxide, preferably 0.1-1 wt.% of colloidal silicone dioxide relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of magnesium stearate, preferably 0.5-2 wt.% of magnesium stearate, more preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0373] In some embodiments, the tablet comprises: a) 50-75 wt.% of granules, preferably 55-70 wt.% of granules, more preferably 60-65 wt.% of granules relative to the total weight of the tablet core, wherein the granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-50% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of microcrystalline cellulose, preferably 10-15 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, a3) 2-6 wt.% of hydroxypropyl cellulose, more preferably 2-4 wt.% of hydroxypropyl cellulose relative to the total weight of the tablet core, a4) optionally, 2-6 wt.% of sodium starch glycolate, more preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b) 15-25 wt.% of granules comprising ezetimibe relative to the total weight of the tablet core, c) 10-25 wt.% extragranular phase comprising: cl) 5-30 wt.% of microcrystalline cellulose, preferably 10-25 wt.% of microcrystalline cellulose, more preferably 15-20 wt.% of microcrystalline cellulose relative to the total weight of the tablet core, c2) 1-10 wt.% of sodium starch glycolate, preferably 2-8 wt.% of sodium starch glycolate, more preferably 2-6 wt.% of sodium starch glycolate, most preferably 2-4 wt.% of sodium starch glycolate relative to the total weight of the tablet core, c3) optionally, 0.1-2 wt.% of colloidal silicone dioxide, preferably 0.1-1.5 wt.% of colloidal silicone dioxide, preferably 0.5-1.5 of colloidal silicone dioxide relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

[0374] In the tablet of the present invention any ezetimibe granules known in prior art can be used, for example ezetimibe granules as described in WO 02 / 058732 A2, WO 2018 / 218147 Al.

[0375] In one preferred embodiment, ezetimibe granules comprise: bl) 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-20 wt.% of intragranular diluent, preferably 12-17 wt.% of intragranular diluent relative to the total weight of the tablet core, b3) 0.1-1 wt.% of intragranular solubilizing agent, preferably 0.2-0.8 wt.% of intragranular solubilizing agent relative to the total weight of the tablet core, b4) 0. 1-2 wt.% of intragranular binder, preferably 0.2-1 wt.% of intragranular binder relative to the total weight of the tablet core, b5) 0.5-3 wt.% of intragranular disintegrant, preferably 0.5-2 wt.% of intragranular disintegrant relative to the total weight of the tablet core.

[0376] In one preferred embodiment, ezetimibe granules comprise: bl) 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-20 wt.% of microcrystalline cellulose, lactose or a mixture thereof, preferably 12- 17 wt.% of microcrystalline cellulose, lactose or a mixture thereof relative to the total weight of the tablet core, b3) 0.1-1 wt.% of sodium lauryl sulfate, preferably 0.2-0.8 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b4) 0. 1-2 wt.% of povidone, preferably 0.2-1 wt.% of povidone to the total weight of the tablet core, b5) 0.5-3 wt.% of sodium starch glycolate, preferably 0.5-2 wt.% of sodium starch glycolate relative to the total weight of the tablet core.

[0377] In some preferred embodiments, the granules comprise: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules, a6) optionally, 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules, a7) optionally, 0.5-3 wt.% of the intragranular glidant, preferably 1-2 wt.% of the intragranular glidant relative to the total weight of the granules, a8) optionally, 0.5-3 wt.% of the intragranular lubricant, preferably 1-2 wt.% of the intragranular lubricant relative to the total weight of the granules. In some preferred embodiments, the granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 60-75 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules, a6) optionally, 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules.

[0378] In some preferred embodiments, the granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 60-75 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules.

[0379] In some preferred embodiments, the granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 60-75 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules.

[0380] In some preferred embodiments, the granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 60-75 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules.

[0381] In some preferred embodiments, the tablet comprises: a) the granules comprising: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules, a6) optionally, 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules, a7) optionally, 0.5-3 wt.% of the intragranular glidant, preferably 1-2 wt.% of the intragranular glidant relative to the total weight of the granules, a8) optionally, 0.5-3 wt.% of the intragranular lubricant, preferably 1-2 wt.% of the intragranular lubricant relative to the total weight of the granules.

[0382] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules.

[0383] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules.

[0384] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules, a5) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a6) 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules.

[0385] In some preferred embodiments, the tablet comprises granules, wherein granules comprise bempedoic acid and ezetimibe, and the extragranular phase comprising: bl) 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, even more preferably 65-80 wt.% of the extragranular diluent, most preferably 70-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, b2) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b3) optionally, 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase, b4) optionally, 1-5 wt.% of the extragranular glidant, preferably 2-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase, b5) optionally, 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0386] In some preferred embodiments, the tablet comprises: a) granules comprising: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, a3) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a5) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, a6) 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the tablet core, a7) optionally, 0.5-3 wt.% of the intragranular glidant, more preferably 0.5-2 wt.% of the intragranular glidant relative to the total weight of the tablet core, a8) optionally, 0.5-3 wt.% of the intragranular lubricant, more preferably 0.5-2 wt.% of the intragranular lubricant relative to the total weight of the tablet core.

[0387] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, a3) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a5) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, a6) optionally, 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the tablet core.

[0388] In some preferred embodiments, the tablet comprises granules, wherein granules comprise bempedoic acid and ezetimibe, and the extragranular phase comprising: b) extragranular phase comprising: bl) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b2) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular water-soluble acid relative to the total weight of the tablet core, b4) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b5) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0389] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of the intragranular diluent, preferably 15-25 wt.% of the intragranular diluent, more preferably 15-20 wt.% of the intragranular diluent relative to the total weight of the granules, a4) 2-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder relative to the total weight of the granules, a5) optionally, 2-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant relative to the total weight of the granules, a6) optionally, 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the granules, b) extragranular phase comprising: bl) 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, even more preferably 65-80 wt.% of the extragranular diluent, most preferably 70-75 wt.% of the extragranular diluent relative to the total weight of the extragranular phase, b2) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b3) optionally, 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase, b4) optionally, 1-5 wt.% of the extragranular glidant, preferably 2-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase, b5) optionally, 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

[0390] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, a3) 5-20 wt.% of the intragranular diluent, most preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a4) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a5) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, a6) optionally, 0.2-2 wt.% of the intragranular solubilizing agent, preferably 0.3-1 wt.% of the intragranular solubilizing agent relative to the total weight of the tablet core, b) extragranular phase comprising: bl) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b2) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, 0.3-2 wt.% of the extragranular glidant, preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

[0391] In some preferred embodiments, the tablet is comprising granules, wherein granules comprise bempedoic acid and ezetimibe, and the extragranular phase, according to any one of embodiments above, whereinthe intragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the intragranular binder is povidone or hydroxypropylmethyl cellulose, the intragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the intragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the intragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid, the intragranular solubilizing agent is sodium lauryl sulfate, the extragranular diluent is microcrystalline cellulose, lactose, lactose monohydrate, lactose anhydrous, mannitol, starch, or a mixture thereof, the extragranular disintegrant is sodium starch glycolate, crosslinked polyvinylpyrrolidone, croscarmellose sodium or low-substituted hydroxypropyl cellulose, the extragranular solubilizing agent is sodium lauryl sulfate, the extragranular glidant is silicon dioxide, talc or sodium stearyl fumarate, the extragranular lubricant is magnesium stearate, sodium stearyl fumarate or stearic acid.

[0392] In some more preferred embodiments, the tablet is comprising granules, wherein granules comprise bempedoic acid and ezetimibe, and the extragranular phase, according to any one of embodiments above, wherein the intragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, more preferably microcrystalline cellulose, the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose, the intragranular disintegrant is sodium starch glycolate, the intragranular solubilizing agent is sodium lauryl sulfate, the intragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the intragranular lubricant is magnesium stearate, the extragranular diluent is a mixture of microcrystalline cellulose and lactose, preferably a mixture of microcrystalline cellulose and lactose monohydrate, the extragranular disintegrant is sodium starch glycolate, the extragranular solubilizing agent is sodium lauryl sulfate, the extragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the extragranular lubricant is magnesium stearate.

[0393] In some preferred embodiments, the granules comprise: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of microcrystalline cellulose, preferably 15-25 wt.% microcrystalline cellulose, more preferably 15-20 wt.% of microcrystalline cellulose relative to the total weight of the granules, a4) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose relative to the total weight of the granules, a5) optionally, 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate relative to the total weight of the granules, a6) optionally, 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the granules, a7) optionally, 0.5-3 wt.% of colloidal silicon dioxide, preferably 1-2 wt.% of colloidal silicon dioxide relative to the total weight of the granules, a8) optionally, 0.5-3 wt.% of magnesium stearate, preferably 1-2 wt.% of magnesium stearate relative to the total weight of the granules.

[0394] In some preferred embodiments, the granules are consisting of: al) 50-80 wt.% of bempedoic acid, preferably 60-75 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of microcrystalline cellulose, preferably 15-25 wt.% microcrystalline cellulose, more preferably 15-20 wt.% of microcrystalline cellulose relative to the total weight of the granules, a4) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose relative to the total weight of the granules, a5) optionally, 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate relative to the total weight of the granules, a6) optionally, 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the granules.

[0395] In some preferred embodiments, the tablet comprises: a) granules consisting of: al) 50-80 wt.% of bempedoic acid, preferably 65-80 wt.% of bempedoic acid, more preferably 65-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 2-6 wt.% of ezetimibe, preferably 3-5 wt.% of ezetimibe relative to the total weight of the granules, a3) 10-25 wt.% of microcrystalline cellulose, preferably 15-25 wt.% microcrystalline cellulose, more preferably 15-20 wt.% of microcrystalline cellulose relative to the total weight of the granules, a4) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose relative to the total weight of the granules, a5) optionally, 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate relative to the total weight of the granules, a6) optionally, 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the granules, b) extragranular phase comprising: bl) 40-85 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 50-80 wt.% of the mixture of microcrystalline cellulose and lactose, more preferably 60-80 wt.% of the mixture of microcrystalline cellulose and lactose, even more preferably 65-80 wt.% of the mixture of microcrystalline cellulose and lactose, most preferably 70-75 wt.% of the mixture of microcrystalline cellulose and lactose relative to the total weight of the extragranular phase, b2) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of sodium starch glycolate, more preferably 5-15 wt.% of sodium starch glycolate, most preferably 8-14 wt.% of sodium starch glycolate relative to the total weight of the extragranular phase, b3) optionally, 0.5-3 wt.% of extragranular sodium lauryl sulfate, preferably 1-2 wt.% of sodium lauryl sulfate relative to the total weight of the extragranular phase, b4) optionally, 1-5 wt.% of colloidal silicon dioxide, preferably 2-4 wt.% of colloidal silicon dioxide relative to the total weight of the extragranular phase, b5) optionally, 1-15 wt.% of magnesium stearate, preferably 1-5 wt.% of magnesium stearate, more preferably 5-10 wt.% of magnesium stearate relative to the total weight of the extragranular phase.

[0396] In some preferred embodiments, the tablet comprises: a) 50-70 wt.% of the granules comprising bempedoic acid and ezetimibe, preferably 55-65 wt.% of the granules comprising bempedoic acid and ezetimibe relative to the total weight of the tablet core, b) 30-50 wt.% of the extragranular phase, preferably 35-45 wt.% of the extragranular phase relative to the total weight of the tablet core.

[0397] The tablet cores of the present invention might be coated with a fdm coating. For example, commercially available Opadry® fdm coating systems or other standard fdm coating compositions might be used. In some preferred embodiments the coating comprises one or more of inactive ingredients selected form cellulose ether derivatives, e.g. hydroxypropyl methylcellulose, methylcellulose, hydroxypropylcellulose, sodium carboxy methylcellulose, vinyl polymers, e.g. polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol, glycerol monocaprylocaprate, sodium lauryl sulfate, titanium dioxide, aluminium lakes, talc, etc.

[0398] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granules comprising bempedoic acid, the intragranular diluent, the intragranular binder, optionally, the intragranular disintegrant and, optionally, the intragranular glidant and / or the intragranular lubricant, b) mixing granules with ezetimibe and extragranular excipients comprising the extragranular diluent, the extragranular disintegrant, the extragranular solubilizing agent and optionally, the extragranular glidant and / or the extragranular lubricant, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating.

[0399] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by dissolving the intragranular binder in water, b) mixing bempedoic acid, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with ezetimibe, the extragranular diluent, the extragranular disintegrant, the extragranular solubilizing agent and optionally, the extragranular glidant and / or the extragranular lubricant, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0400] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by dissolving the intragranular binder in water, b) mixing bempedoic acid, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing ezetimibe, the extragranular diluent, the extragranular disintegrant, the extragranular solubilizing agent, and the extragranular glidant, g) mixing granules obtained in step d) or in step e) with the mixture obtained in step f), h) mixing the mixture obtained in step g) with the extragranular lubricant, i) compressing the mixture obtained in step h) to tablets, j) optionally, coating obtained tablet cores with a film-coating.

[0401] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) mixing bempedoic acid, the intragranular binder, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the intragranular lubricant to obtain granulating mixture, b) spraying the granulation liquid comprising water on the granulating mixture obtained in step a), preferably in a high-shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing granules with ezetimibe, the extragranular diluent, the extragranular disintegrant, the extragranular solubilizing agent and optionally, the extragranular glidant and / or the extragranular lubricant, f) compressing the mixture obtained in step e) to tablets, g) optionally, coating obtained tablet cores with a film-coating.

[0402] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) mixing bempedoic acid, the intragranular binder, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the intragranular lubricant to obtain granulating mixture, b) spraying the granulation liquid comprising water on the granulating mixture obtained in step a), preferably in a high-shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing ezetimibe, the extragranular diluent, the extragranular disintegrant, the extragranular solubilizing agent, and the extragranular glidant, f) mixing granules obtained in step c) or in step d) with the mixture obtained in step e), g) mixing the mixture obtained in step f) with the extragranular lubricant, h) compressing the mixture obtained in step g) to tablets, i) optionally, coating obtained tablet cores with a film-coating.

[0403] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granules comprising bempedoic acid, microcrystalline cellulose, hydroxypropyl cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate, b) mixing granules with ezetimibe, microcrystalline cellulose, lactose, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating.

[0404] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose in water, b) mixing bempedoic acid, microcrystalline cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with ezetimibe, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0405] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose in water, b) mixing bempedoic acid, microcrystalline cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing ezetimibe, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide, g) mixing granules obtained in step d) or in step e) with the mixture obtained in step f), h) mixing the mixture obtained in step g) with magnesium stearate, i) compressing the mixture obtained in step h) to tablets, j) optionally, coating obtained tablet cores with a film-coating.

[0406] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) mixing bempedoic acid, hydroxypropyl cellulose, microcrystalline cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, b) spraying water on the granulating mixture obtained in step a), preferably in a high- shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing granules with ezetimibe, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, f) compressing the mixture obtained in step e) to tablets, g) optionally, coating obtained tablet cores with a fdm-coating.

[0407] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) mixing bempedoic acid, hydroxypropyl cellulose, microcrystalline cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, b) spraying water on the granulating mixture obtained in step a), preferably in a high- shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing ezetimibe, microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide, f) mixing granules obtained in step c) or in step d) with the mixture obtained in step e), g) mixing the mixture obtained in step f) with magnesium stearate, h) compressing the mixture obtained in step g) to tablets, i) optionally, coating obtained tablet cores with a film-coating.

[0408] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granules comprising bempedoic acid, ezetimibe, the intragranular diluent, the intragranular binder, optionally, the intragranular disintegrant, optionally, the intragranular solubilizing agent, and, optionally, the intragranular glidant and / or the intragranular lubricant, b) mixing granules with extragranular excipients comprising the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and optionally, the extragranular glidant and / or the extragranular lubricant, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating.

[0409] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by dissolving the intragranular binder and, optionally, the intragranular solubilizing agent, in water, b) mixing bempedoic acid, ezetimibe, the intragranular diluent, optionally, the intragranular disintegrant, optionally, the intragranular solubilizing agent, and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and optionally, the extragranular glidant and / or the extragranular lubricant, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0410] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by dissolving the intragranular binder, and optionally, the intragranular solubilizing agent, in water, b) mixing bempedoic acid, ezetimibe, the intragranular diluent, optionally, the intragranular disintegrant, optionally, the intragranular solubilizing agent, and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and the extragranular glidant, g) mixing granules obtained in step d) or in step e) with the mixture obtained in step f), h) mixing the mixture obtained in step g) with the extragranular lubricant, i) compressing the mixture obtained in step h) to tablets, j) optionally, coating obtained tablet cores with a film-coating. In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granules comprising bempedoic acid, ezetimibe, microcrystalline cellulose, hydroxypropyl cellulose, optionally, sodium starch glycolate, optionally, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, b) mixing granules with microcrystalline cellulose, lactose, sodium starch glycolate, optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate, c) compressing obtained mixture to tablets, d) optionally, coating obtained tablet cores with a film-coating.

[0411] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose, and optionally, sodium lauryl sulfate, in water, b) mixing bempedoic acid, ezetimibe, microcrystalline cellulose, sodium starch glycolate, optionally, sodium lauryl sulfate, and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with microcrystalline cellulose, lactose, sodium starch glycolate, optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0412] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose, and optionally, sodium lauryl sulfate in water, b) mixing bempedoic acid, ezetimibe, microcrystalline cellulose, optionally, sodium starch glycolate, optionally, sodium lauryl sulfate, and optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing lactose, microcrystalline cellulose, sodium starch glycolate and silicon dioxide, g) mixing granules obtained in step d) or in step e) with the mixture obtained in step f), h) mixing the mixture obtained in step g) with magnesium stearate, i) compressing the mixture obtained in step h) to tablets, j) optionally, coating obtained tablet cores with a film-coating.

[0413] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving the intragranular binder, and the intragranular solubilizing agent, in water, b) mixing bempedoic acid, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and optionally, the extragranular glidant and / or the extragranular lubricant, g) compressing the mixture obtained in step f) to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0414] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving the intragranular binder and the intragranular solubilizing agent, in water, b) mixing bempedoic acid, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and the extragranular glidant, g) mixing granules obtained in step d) or in step e) with the mixture obtained in step f), h) mixing the mixture obtained in step g) with the extragranular lubricant, i) compressing the mixture obtained in step h) to tablets, j) optionally, coating obtained tablet cores with a film-coating.

[0415] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving hydroxypropyl cellulose, ezetimibe and sodium lauryl sulfate in water, b) mixing bempedoic acid, microcrystalline cellulose, optionally, sodium starch glycolate and, optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing granules with microcrystalline cellulose, lactose, sodium starch glycolate, optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate, g) compressing obtained mixture to tablets, h) optionally, coating obtained tablet cores with a film-coating.

[0416] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving hydroxypropyl cellulose and sodium lauryl sulfate in water, b) mixing bempedoic acid, microcrystalline cellulose, optionally, sodium starch glycolate, and optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules, f) mixing lactose, microcrystalline cellulose, sodium starch glycolate and silicon dioxide, g) mixing granules obtained in step d) or in step e) with the mixture obtained in step f), h) mixing the mixture obtained in step g) with magnesium stearate, i) compressing the mixture obtained in step h) to tablets, j) optionally, coating obtained tablet cores with a film-coating.

[0417] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) mixing bempedoic acid, ezetimibe, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, b) spraying water on the granulating mixture obtained in step a), preferably in a high- shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing granules with microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, sodium lauryl sulfate and optionally, silicon dioxide and / or magnesium stearate, f) compressing the mixture obtained in step e) to tablets, g) optionally, coating obtained tablet cores with a film-coating.

[0418] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) mixing bempedoic acid, ezetimibe, the intragranular diluent, optionally, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, b) spraying water on the granulating mixture obtained in step a), preferably in a high- shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator, d) optionally, sieving the obtained dry granules, e) mixing the extragranular diluent, the extragranular disintegrant, optionally, the extragranular solubilizing agent, and the extragranular glidant, f) mixing granules obtained in step c) or in step d) with the mixture obtained in step e), g) mixing the mixture obtained in step f) with the extragranular lubricant, h) compressing the mixture obtained in step g) to tablets, i) optionally, coating obtained tablet cores with a film-coating.

[0419] Dried granules obtained according to any of process according to the above embodiments can be sieved before being used in further steps. Dried granules might be sieved through sieve with sieve opening 0.5-2.0 mm, preferably 1.0 mm. In some preferred embodiments, a process for preparing the granules comprises the following steps: a) preparing granulation liquid by dissolving the intragranular binder, and optionally, the intragranular solubilizing agent, in water, b) mixing bempedoic acid, ezetimibe, the intragranular diluent, the intragranular disintegrant, optionally, the intragranular solubilizing agent, and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules.

[0420] In some preferred embodiments, a process for preparing the granules comprises the following steps: a) preparing granulation liquid by dissolving hydroxypropyl cellulose, and optionally, sodium lauryl sulfate in water, b) mixing bempedoic acid, ezetimibe, microcrystalline cellulose, sodium starch glycolate, and optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator, e) optionally, sieving the obtained dry granules.

[0421] In some preferred embodiments, a process for preparing the granules comprises the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving the intragranular binder and the intragranular solubilizing agent, in water, b) mixing bempedoic acid, the intragranular diluent, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator.

[0422] In some preferred embodiments, a process for preparing the granules comprises the following steps: a) preparing granulation liquid by suspending ezetimibe and dissolving hydroxypropyl cellulose and sodium lauryl sulfate in water, b) mixing bempedoic acid, microcrystalline cellulose, sodium starch glycolate, and optionally, sodium lauryl sulfate, and optionally, silicon dioxide and / or magnesium stearate to obtain granulating mixture, c) spraying the granulation liquid obtained in step a) on the granulating mixture obtained in step b), preferably in a high-shear mixer, d) drying the obtained granules, preferably in a fluid bed granulator.

[0423] In some preferred embodiments, a process for preparing the tablet comprises the following steps: a) mixing bempedoic acid, ezetimibe, the intragranular diluent, the intragranular disintegrant and optionally, the intragranular glidant and / or the extragranular lubricant to obtain granulating mixture, b) spraying water on the granulating mixture obtained in step a), preferably in a high- shear mixer, c) drying the obtained granules, preferably in a fluid bed granulator.

[0424] Furthermore, it has been surprisingly found that tablet comprising bempedoic acid can be prepared without granulating bempedoic acid by using direct compression method. What means that a manufacturing process is less complex.

[0425] Another aspect of the present invention is a tablet comprising bempedoic acid prepared by direct compression.

[0426] In some embodiments, the tablet prepared by direct compression comprises: a) 30-70 wt.% of bempedoic acid, preferably 40-60 wt.% of bempedoic acid, more preferably 45-55 wt.% of bempedoic acid relative to the total weight of the tablet core, b) 20-50 wt.% of the diluent, preferably 30-40 wt.% of the diluent, more preferably 25-35 wt.% of the diluent relative to the total weight of the tablet core, c) 2-10 wt.% of the binder, preferably 2-8 wt.% of the binder, more preferably 2-6 wt.% of the binder relative to the total weight of the tablet core, d) 2-15 wt.% of the disintegrant, preferably 3-10 wt.% of the disintegrant, more preferably 5-10 wt.% of the disintegrant relative to the total weight of the tablet core, e) optionally, 1-8 wt.% of the glidant, preferably 2-6 wt.% of the glidant, more preferably 2-4 wt.% of the glidant relative to the total weight of the tablet core, f) optionally, 2-10 wt.% of the lubricant, preferably 2-8 wt.% of the lubricant, more preferably 2-6 wt.% of the lubricant relative to the total weight of the tablet core.

[0427] In some embodiments, the tablet comprises: a) 30-70 wt.% of bempedoic acid, preferably 40-60 wt.% of bempedoic acid, more preferably 45-55 wt.% of bempedoic acid relative to the total weight of the tablet core, b) 20-50 wt.% of the diluent, preferably 30-40 wt.% of the diluent, more preferably 25-35 wt.% of the diluent relative to the total weight of the tablet core, c) 2-10 wt.% of the binder, preferably 2-8 wt.% of the binder, more preferably 2-6 wt.% of the binder relative to the total weight of the tablet core, d) 2-15 wt.% of the disintegrant, preferably 3-10 wt.% of the disintegrant, more preferably 5-10 wt.% of the disintegrant relative to the total weight of the tablet core, e) 1-8 wt.% of the glidant, preferably 2-6 wt.% of the glidant, more preferably 2-4 wt.% of the glidant relative to the total weight of the tablet core, f) 2-10 wt.% of the lubricant, preferably 2-8 wt.% of the lubricant, more preferably 2-

[0428] 6 wt.% of the lubricant relative to the total weight of the tablet core.

[0429] The tablet prepared by direct compression might comprise diluents, binders, disintegrants. glidants and lubricants as listed above in case of other aspects and embodiments.

[0430] In some preferred embodiments, the tablet comprises: a) 30-70 wt.% of bempedoic acid, preferably 40-60 wt.% of bempedoic acid, more preferably 45-55 wt.% of bempedoic acid relative to the total weight of the tablet core, b) 20-50 wt.% of the mixture of microcrystalline cellulose and lactose, preferably 30- 40 wt.% of the mixtur...

Claims

Claims1. A tablet, in particular a tablet comprising a tablet core and optionally a coating, the tablet comprising bempedoic acid granules and optionally ezetimibe.

2. The tablet according to claim 1, wherein the tablet comprises: a) bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, more preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) extragranular phase comprising: bl) an extragranular diluent, b2) optionally, an extragranular disintegrant, b3) optionally, an extragranular glidant, b4) optionally, an extragranular lubricant.

3. The tablet according to claim 2, wherein the tablet comprises: a) bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, more preferably 50-55 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) the extragranular phase comprising: bl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 15-20 wt.% of the extragranular diluent, relative to the total weight of the tablet core, b2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b3) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core,b4) optionally, 0.5-5 wt.% of the extragranular lubricant, , preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

4. The tablet according to claim 2 or claim 3, wherein the tablet comprises: a) 50-90 wt.% of bempedoic acid granules, preferably 55-80 wt.% of bempedoic acid granules, more preferably 60-75 wt.% of bempedoic acid granules, most preferably 65- 75 wt.% of bempedoic acid granules relative to the total weight of the tablet core, b) 10-50 wt.% of the extragranular phase, preferably 20-45 wt.% of the extragranular phase, more preferably 25-40 wt.% of the extragranular phase, most preferably 25-35 wt.% of the extragranular phase relative to the total weight of the tablet core.

5. The tablet according to claim 1, wherein the tablet comprises: a) bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) ezetimibe granules, c) the extragranular phase comprising: cl) an extragranular diluent, c2) optionally, an extragranular disintegrant, c3) optionally, an extragranular glidant, c4) optionally, an extragranular lubricant.

6. The tablet according to claim 5, wherein the tablet comprises: a) bempedoic acid granules consisting of: al) 35-55 wt.% of bempedoic acid, preferably 40-55 wt.% of bempedoic acid, more preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-20 wt.% of the intragranular diluent, preferably 10-15 wt.% of the intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of the intragranular binder, preferably 2-6 wt.% of the intragranular binder, more preferably 2-4 wt.% of the intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of the intragranular disintegrant, preferably 2-6 wt.% of the intragranular disintegrant, more preferably 2-4 wt.% of the intragranular disintegrant relative to the total weight of the tablet core, b) ezetimibe granules, c) the extragranular phase comprising: cl) 5-30 wt.% of the extragranular diluent, preferably 10-25 wt.% of the extragranular diluent, more preferably 10-15 wt.% of the extragranular diluent, relative to the total weight of the tablet core,c2) optionally, 1-10 wt.% of the extragranular disintegrant, preferably 2-8 wt.% of the extragranular disintegrant, more preferably 2-6 wt.% of the extragranular disintegrant, most preferably 2-4 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, c3) optionally, comprises 0.1-2 wt.% of the extragranular glidant, preferably 0.1-1.5 wt.% of the extragranular glidant, more preferably 0.5-1.5 wt.% of the extragranular glidant relative to the total weight of the tablet core, c4) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

7. The tablet according to claim 5 or claim 6, wherein the tablet comprises: a) 50-75 wt.% of bempedoic acid granules, preferably 55-70 wt.% of bempedoic acid granules, more preferably 60-65 wt.% of bempedoic acid granules relative to the total weight of the tablet core, b) 15-25 wt.% of the granules comprising ezetimibe relative to the total weight of the tablet core c) 10-25 wt.% of the extragranular phase of the extragranular phase relative to the total weight of the tablet core.

8. The tablet according to any one of claim 2 to 7, wherein the intragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose monohydrate, more preferably microcrystalline cellulose, the intragranular binder is hydroxypropyl cellulose or povidone, preferably hydroxypropyl cellulose, the intragranular disintegrant is sodium starch glycolate, the intragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the intragranular lubricant is magnesium stearate, the extragranular diluent is microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, preferably microcrystalline cellulose or a mixture of microcrystalline cellulose and lactose, the extragranular disintegrant is sodium starch glycolate, the extragranular glidant is silicon dioxide, preferably colloidal silicon dioxide, more preferably anhydrous colloidal silicon dioxide, the extragranular lubricant is magnesium stearate.

9. A tablet according to claim 1 comprising bempedoic acid granules and ezetimibe in an extragranular phase.

10. The tablet according to claim 9, wherein the tablet comprises: a) bempedoic acid granules, b) the extragranular phase comprising: bl) ezetimibe. b2) an extragranular diluent, b3) an extragranular disintegrant,b4) optionally, an extragranular solubilizing agent, b5) optionally, an extragranular glidant, b6) optionally, an extragranular lubricant.

11. The tablet according to claim 9 or claim 10, wherein the tablet comprises: a) bempedoic acid granules, b) the extragranular phase comprising: bl) 4-10 wt.% of ezetimibe, preferably 5-8 wt.% of ezetimibe, more preferably 6-7 wt.% of ezetimibe relative to the total weight of the extragranular phase, b2) 40-85 wt.% of the extragranular diluent, preferably 50-80 wt.% of the extragranular diluent, more preferably 60-80 wt.% of the extragranular diluent, most preferably OSTS wt.% of the extragranular diluent relative to the total weight of the extragranular phase, b3) 5-20 wt.% of the extragranular disintegrant, preferably 15-20 wt.% of the extragranular disintegrant, more preferably 5-15 wt.% of the extragranular disintegrant, most preferably 8-14 wt.% of the extragranular disintegrant relative to the total weight of the extragranular phase, b4) 0.5-3 wt.% of the extragranular solubilizing agent, preferably 1-2 wt.% of the extragranular solubilizing agent relative to the total weight of the extragranular phase, b5) optionally, 0.2-6 wt.% of the extragranular glidant, preferably 1-6 wt.% of the extragranular glidant or 0.2-1 wt.% of the extragranular glidant, more preferably 0.2- 0.5 wt.% of the extragranular glidant, most preferably 1-4 wt.% of the extragranular glidant relative to the total weight of the extragranular phase, b6) optionally, 1-15 wt.% of the extragranular lubricant, preferably 1-5 wt.% of the extragranular lubricant, more preferably 5-10 wt.% of the extragranular lubricant relative to the total weight of the extragranular phase.

12. The tablet according to any one of claims 9 to 11, wherein the tablet comprises: a) bempedoic acid granules, b) the extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 5-30 wt.% of extragranular microcrystalline cellulose and 5-30 wt.% of extragranular lactose, preferably 5-20 wt.% of extragranular microcrystalline cellulose and 5-25 wt.% of extragranular lactose, more preferably 10-20 wt.% of extragranular microcrystalline cellulose and 10-25 wt.% of extragranular lactose, even more preferably 10-15 wt.% of extragranular microcrystalline cellulose and 10-15 wt.% of extragranular lactose relative to the total weight of the tablet core, b3) 2-10 wt.% of sodium starch glycolate, preferably 3-8 wt.% of sodium starch glycolate, more preferably 6-8 wt.% of sodium starch glycolate, most preferably 3-6 wt.% of sodium starch glycolate relative to the total weight of the tablet core, b4) 0.2-2 wt.% of sodium lauryl sulfate, preferably 0.3-1 wt.% of sodium lauryl sulfate relative to the total weight of the tablet core, b5) optionally, 0.3-2 wt.% of colloidal silicon dioxide, preferably 0.5-2 wt.% of colloidal silicon dioxide relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of magnesium stearate, preferably 1-4 wt.% of magnesium stearate, more preferably 1-2 wt.% of magnesium stearate, most preferably 2-4 wt.% of magnesium stearate relative to the total weight of the tablet core.

13. The tablet according to any one of claims 9 to 12, wherein the tablet comprises: a) the bempedoic acid granules comprising: al) 30-60 wt.% of bempedoic acid, preferably 35-55 wt.% of bempedoic acid, more preferably 40-50% of bempedoic acid, most preferably 42-47 wt.% of bempedoic acid relative to the total weight of the tablet core, a2) 5-40 wt.% of intragranular diluent, preferably 5-30 wt.% of intragranular diluent, more preferably 5-20 wt.% of intragranular diluent, most preferably 10-15 wt.% of intragranular diluent relative to the total weight of the tablet core, a3) 1-8 wt.% of intragranular binder, preferably 2-6 wt.% of intragranular binder, more preferably 2-4 wt.% of intragranular binder relative to the total weight of the tablet core, a4) optionally, 1-8 wt.% of intragranular disintegrant, preferably 2-6 wt.% of intragranular disintegrant, more preferably 2-4 wt.% of intragranular disintegrant relative to the total weight of the tablet core, a5) optionally, 0.5-3 wt.% of intragranular glidant, more preferably 0.5-2 wt.% of intragranular glidant relative to the total weight of the tablet core, a6) optionally, 0.5-3 wt.% of intragranular lubricant, more preferably 0.5-2 wt.% of intragranular lubricant relative to the total weight of the tablet core, b) the extragranular phase comprising: bl) 1.5-5 wt.% of ezetimibe, preferably 2-4 wt.% of ezetimibe, more preferably 2-3 wt.% of ezetimibe relative to the total weight of the tablet core, b2) 10-50 wt.% of the extragranular diluent, preferably 10-40 wt.% of the extragranular diluent, more preferably 15-35 wt.% of the extragranular diluent, even more preferably 30-40 wt.% of the extragranular diluent, even more preferably 20-30 wt.% of the extragranular diluent relative to the total weight of the tablet core, b3) 2-10 wt.% of the extragranular disintegrant, preferably 3-8 wt.% of the extragranular disintegrant, more preferably 6-8 wt.% of the extragranular disintegrant, most preferably 3-6 wt.% of the extragranular disintegrant relative to the total weight of the tablet core, b4) 0.2-2 wt.% of the extragranular solubilizing agent, preferably 0.3-1 wt.% of the extragranular solubilizing agent relative to the total weight of the tablet core, b5) optionally, 0.1-2 wt.% of the extragranular glidant, preferably 0.3-2 wt.% of the extragranular glidant or 0. 1-0.3 wt.% of the extragranular glidant, more preferably 0.1-0.2 wt.% of the extragranular glidant, most preferably 0.5-2 wt.% of the extragranular glidant relative to the total weight of the tablet core, b6) optionally, 0.5-5 wt.% of the extragranular lubricant, preferably 1-4 wt.% of the extragranular lubricant, more preferably 1-2 wt.% of the extragranular lubricant, most preferably 2-4 wt.% of the extragranular lubricant relative to the total weight of the tablet core.

14. The tablet according to any one of claims 1 to 13, wherein bempedoic acid granules are consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-50 wt.% of microcrystalline cellulose, preferably 10-40 wt.% of microcrystalline cellulose, more preferably 10-30 wt.% of microcrystalline cellulose, most preferably 15-25 wt.% of microcrystalline cellulose relative to the total weight of the granules,a3) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 3-5 wt.% of hydroxypropyl cellulose relative to the total weight of the granules, a4) optionally, 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 3-5 wt.% of sodium starch glycolate relative to the total weight of the granules.

15. Bempedoic acid granules consisting of: al) 65-80 wt.% of bempedoic acid, preferably 70-75 wt.% of bempedoic acid relative to the total weight of the granules, a2) 10-50 wt.% of microcrystalline cellulose, preferably 10-40 wt.% of microcrystalline cellulose, more preferably 10-30 wt.% of microcrystalline cellulose, most preferably 15-25 wt.% of microcrystalline cellulose relative to the total weight of the granules, a3) 2-8 wt.% of hydroxypropyl cellulose, preferably 2-6 wt.% of hydroxypropyl cellulose, more preferably 3-5 wt.% of hydroxypropyl cellulose relative to the total weight of the granules, a4) optionally, 2-8 wt.% of sodium starch glycolate, preferably 2-6 wt.% of sodium starch glycolate, more preferably 3-5 wt.% of sodium starch glycolate relative to the total weight of the granules.

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