Glp1 tablet compositions

Abstract

This invention discloses an tablet composition comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof, and a pH adjuster. In one embodiment, the tablet composition comprises a spray-dried dispersion (SDD) of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof, wherein the SDD also comprises a polymer to maintain an amorphous state.

Description

GLP1 tablet composition The present invention relates to oral tablet compositions of the GLP-1 receptor agonist, 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one (hereinafter, GLP1RA), or a pharmaceutically acceptable salt thereof. The compositions disclosed herein can be used to treat type 2 diabetes (T2D) and weight management. Diabetes mellitus (T2D) is a chronic condition characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. In T2D, the combined effects of impaired insulin secretion and insulin resistance are associated with elevated blood glucose levels. T2D is an increasingly prevalent disease that frequently leads to a decline in patients' health and quality of life. Effective oral treatments are needed to manage T2D and / or for weight management. GLP1RA, i.e., 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof, is described and claimed in US Pat. No. 10,858,356. US Pat. No. 10,858,356 generally describes oral compositions. GLP1RA can be prepared as a pharmaceutically acceptable salt. One salt of GLP1RA is a hemi-calcium hydrate having the structure shown below: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate (hereinafter referred to as "GLP1RA-Ca"). . GLP1RA is a poorly permeable and poorly soluble weak acid with a pKa of 5.1. GLP1RA has very low water solubility across the physiological pH range and in simulated physiological fluids. GLP1RA and its pharmaceutically acceptable salts have been observed to have a strongly pH-dependent solubility profile, which contributes to challenges such as variability in absorption and, therefore, pharmacokinetic properties and potential food effects. For GLP1RA, including but not limited to GLP1RA-Ca, there is a need for tablet compositions that provide reliable PK performance in a patient-friendly dosage form, with minimal potential for drug-drug interactions and reduced or no food effect. GLP1RA compositions that enhance the solubility and dissolution rate of the active substance in a tablet dosage form may be desirable. A pharmaceutically aesthetic dosage form that delivers an effective amount of active GLP1RA to the target portion of the gastrointestinal tract while being small enough to facilitate swallowing by the patient is desired. The compositions described herein provide desired properties. In one aspect, the use of a spray-dried dispersion (SDD) of a GLP1RA or a pharmaceutically acceptable salt thereof as described herein, together with a pH adjuster, contributes to the desired properties. In one aspect, the SDD as described and the specific particle size of a particular composition provide the desired properties. In one aspect, the compositions disclosed herein provide desired pharmacokinetic properties and deliver an effective amount of active GLP1RA to a target portion of the gastrointestinal tract. In one aspect, an aesthetically pleasing dosage form is disclosed herein that is convenient for patients to take without food or water restrictions. The solid oral formulations provided herein can be used in patients in need of treatment for T2D.The solid oral formulations provided herein can be used in patients in need of treatment for long-term weight management. In one embodiment, a tablet composition is provided, comprising: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and a pH adjuster. In one embodiment, the tablet composition disclosed herein is an oral solid composition. In one embodiment, the composition is wherein the pH adjuster is selected from the group consisting of calcium carbonate, magnesium carbonate, sodium bicarbonate, sodium carbonate, magnesium hydroxide, calcium hydroxide, magnesium oxide, and mixtures thereof. In one embodiment, a solid oral tablet composition is provided, comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and a pH adjuster; wherein the pH adjuster is selected from the group consisting of calcium carbonate, anhydrous calcium carbonate, sodium bicarbonate, anhydrous sodium bicarbonate, sodium carbonate, anhydrous sodium carbonate, sodium carbonate hydrate, magnesium hydroxide, and anhydrous magnesium hydroxide. In one embodiment, the pH adjuster is sodium carbonate. In one embodiment, the pH adjuster is anhydrous. In one embodiment, the pH adjuster is anhydrous sodium carbonate. In one embodiment, the pH adjuster is sodium carbonate hydrate. In one embodiment, the pH adjuster is sodium bicarbonate. In one embodiment, the pH adjuster is anhydrous. In one embodiment, the pH adjuster is anhydrous sodium bicarbonate. In one embodiment, a tablet composition is provided, comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and a pH adjuster, wherein the pH adjuster is anhydrous sodium carbonate. In one embodiment, the present invention provides a tablet composition comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; a pH adjuster; and a superdisintegrant. In one embodiment, the super disintegrant is selected from the group consisting of croscarmellose sodium, crospovidone, sodium starch glycolate, and mixtures thereof. In one embodiment, the super disintegrant is selected from the group consisting of croscarmellose sodium and copovidone. In one embodiment, the present invention provides a tablet composition comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; a pH adjuster; and a lubricant. In one embodiment, the lubricant is selected from the group consisting of calcium stearate, magnesium stearate, polyethylene glycol, sodium stearyl fumarate, stearic acid, talc, and mixtures thereof. In one embodiment, the lubricant comprises magnesium stearate. In one embodiment, the lubricant is magnesium stearate. In one embodiment, the present invention provides a tablet composition, wherein the composition comprises 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; a pH adjuster; a superdisintegrant; and a lubricant. In one embodiment, the present invention provides a tablet composition comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; a pH adjuster; a superdisintegrant selected from the group consisting of croscarmellose sodium and copovidone; and a lubricant selected from magnesium stearate. In one embodiment, the present invention provides a tablet composition comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; a pH adjuster; and copovidone. In one embodiment, the tablet composition comprises an enteric coating. In one embodiment, the tablet composition comprises an immediate release coating. In one embodiment, the tablet composition comprises both an immediate release coating and an enteric coating. In one embodiment, the tablet composition comprises 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and a pH adjuster. In one embodiment, the tablet composition comprises 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one in an amount of about 0.5 to about 75 mg per tablet composition. In one embodiment, the tablet composition comprises 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one in an amount of about 0.5 to about 60 mg per tablet; or more specifically, about 0.5 to about 45 mg; or more specifically, about 0.5 to about 36 mg; or even more specifically, about 0.8 to about 36 mg. In one embodiment, the tablet composition comprises 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; in an amount of about 0.5 to about 82 mg per tablet; or more specifically, about 0.5 to about 75 mg; or more specifically, about 0.5 to about 60 mg; or more specifically, about 0.5 to about 45 mg; or more specifically, about 0.8 to about 45 mg. mg; or even more specifically, an amount from about 1 to about 36 mg (all amounts are based on the free acid). As described herein, a conversion factor of approximately 0.91 is assumed for GLP1RA / GLP1RA-Ca (i.e., hemi-calcium salt hydrate of GLP1RA). As will be readily appreciated by those skilled in the art, the exact conversion rate may vary slightly depending on the actual content of the hydrate. In one embodiment, the present invention provides a tablet composition comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; in an amount of about 0.5 mg to about 75 mg (based on the free acid); a pH adjuster selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, sodium carbonate hydrate, magnesium hydroxide, and mixtures thereof; and in an amount of about 0.5 mg to about 15 mg. mg; a super disintegrant selected from the group consisting of croscarmellose sodium and copovidone in an amount of about 2 mg to about 25 mg; and a lubricant selected from the group consisting of calcium stearate, magnesium stearate, polyethylene glycol, sodium stearyl fumarate, stearic acid, talc, and mixtures thereof in an amount of about 0.5 mg to about 5 mg. In one embodiment, the present invention provides a tablet composition comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof in an amount of about 0.7 mg to about 60 mg (based on the free acid); a pH adjuster selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, sodium carbonate hydrate, magnesium hydroxide, and mixtures thereof in an amount of about 5 mg to about 15 mg; A super disintegrant selected from the group consisting of croscarmellose sodium and copovidone in an amount of about 2 mg to about 25 mg; and a lubricant selected from the group consisting of magnesium stearate in an amount of about 0.5 mg to about 5 mg. In one embodiment, the present invention provides a tablet composition comprising: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof in an amount of about 0.8 mg to about 45 mg (based on the free acid); a pH adjuster selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, sodium carbonate hydrate, magnesium hydroxide, and mixtures thereof in an amount of about 5 mg to about 15 mg; A super disintegrant selected from the group consisting of croscarmellose sodium and copovidone in an amount of about 2 mg to about 17.5 mg; and a lubricant selected from the group consisting of magnesium stearate in an amount of about 1 mg to about 2.5 mg. In one embodiment, the present invention provides a tablet composition comprising: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof in an amount of about 1 mg to about 36 mg (based on the free acid); a pH adjuster selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, sodium carbonate hydrate, magnesium hydroxide, and mixtures thereof in an amount of about 5 mg to about 10 mg; A super disintegrant selected from the group consisting of croscarmellose sodium and copovidone in an amount of about 5 mg to about 20 mg; and a lubricant selected from the group consisting of magnesium stearate in an amount of about 1 mg to about 2.5 mg. In one embodiment, the present invention provides a tablet composition comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; in an amount of about 1 mg to about 30 mg (based on the free acid); a pH adjuster selected from the group consisting of anhydrous calcium carbonate, anhydrous sodium bicarbonate, anhydrous sodium carbonate, sodium carbonate hydrate, and anhydrous magnesium hydroxide; and in an amount of about 6 mg to about 8 mg. mg amount; a super disintegrant selected from the group consisting of croscarmellose sodium and copovidone in an amount of about 10 mg to about 18 mg; and a lubricant of magnesium stearate in an amount of about 1.5 mg to about 2 mg. In one embodiment, the present invention provides a tablet composition, wherein the composition comprises 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; in an amount of about 0.8 mg to about 45 mg (based on the free acid); anhydrous sodium carbonate as a pH adjuster; in an amount of about 8 mg; a super disintegrant of copovidone; and in an amount of about 17.5 mg amount; and a lubricant of magnesium stearate; in an amount of about 2 mg. In one embodiment, the present invention provides a tablet composition, wherein the composition comprises 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; in an amount of about 1 mg to about 36 mg (based on the free acid); anhydrous sodium carbonate as a pH adjuster; in an amount of about 8 mg; copovidone as a super disintegrant; and in an amount of about 17.5 mg amount; and a lubricant of magnesium stearate; in an amount of about 2 mg. In one embodiment, the present invention provides a tablet composition, wherein the composition comprises 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; in an amount of about 45 mg to about 60 mg (based on the free acid); anhydrous sodium carbonate as a pH adjuster; in an amount of about 8 mg; a super disintegrant of copovidone; and in an amount of about 17.5 mg amount; and a lubricant of magnesium stearate; in an amount of about 2 mg. In one embodiment, a GLP1RA or a pharmaceutically acceptable salt thereof is prepared as a spray-dried dispersion (SDD) for use as the active drug in a tablet composition. In one embodiment, an SDD of a GLP1RA or a pharmaceutically acceptable salt thereof is prepared under the conditions described in Formulations 2 and 3 below. In one embodiment, the GLP1RA ("3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one") or GLP1RA-Ca ("3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate") is present in the compositions described herein as an SDD formulation. Generally speaking, the SDD formulations disclosed herein comprise a GLP1RA or a pharmaceutically acceptable salt thereof and a polymer as a further component to maintain the GLP1RA or its pharmaceutically acceptable salt in an amorphous state. In one embodiment, the polymer is selected from the group consisting of polyvinylpyrrolidone (also known as "povidone" or "PVP") and polyvinylpyrrolidone vinyl acetate (also known as "copovidone" or "PVP-VA"). In one embodiment, the polymer is PVP-VA. In one embodiment, the polymer is PVP. In one embodiment, when the weight percentage of a GLP1RA or a pharmaceutically acceptable salt thereof in an SDD formulation is specified, the remaining component of the SDD is a polymer selected from PVP and PVP-VA, i.e., the total weight percentage of the GLP1RA or a pharmaceutically acceptable salt thereof and the polymer is 100 weight %. In one embodiment, the polymer is PVP-VA. In one embodiment, the polymer is PVP. In one embodiment, the SDD formulation comprises about 20% to about 40% by weight of a GLP1RA or GLP1RA-Ca, with the remainder consisting of PVP-VA. In one embodiment, the SDD formulation comprises about 30% to about 35% by weight of a GLP1RA or GLP1RA-Ca, with the remainder consisting of PVP-VA. In one embodiment, the SDD formulation comprises about 30% by weight of a GLP1RA or GLP1RA-Ca, with the remainder consisting of PVP-VA. In one embodiment, the SDD formulation comprises about 30% by weight of a GLP1RA or GLP1RA-Ca, with the remainder consisting of PVP-VA. In one embodiment, the average particle size of the GLP1RA or GLP1RA-Ca SDD is from about 5 µm to about 150 µm in diameter. In one embodiment, the average particle size of the SDD is from about 5 µm to about 113 µm in diameter. In one embodiment, the average particle size of the SDD is from about 40 µm to about 65 µm in diameter. In one embodiment, the average particle size of the SDD is from about 40 µm to about 50 µm in diameter. In one embodiment, the average particle size of the SDD is from about 5 µm to about 25 µm in diameter. In one embodiment, a tablet composition is provided, comprising: an SDD comprising 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and a pH adjuster. In one embodiment, the pH adjuster is selected from the group consisting of calcium carbonate, magnesium carbonate, sodium bicarbonate, sodium carbonate, magnesium hydroxide, calcium hydroxide, magnesium oxide, and mixtures thereof. In one embodiment, the pH adjuster is sodium bicarbonate. In one embodiment, the pH adjuster is sodium carbonate. In one embodiment, the pH adjuster is anhydrous sodium carbonate. In one embodiment, a tablet composition is provided, comprising: about 20% to about 40% by weight of SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and a pH adjuster selected from the group consisting of calcium carbonate, magnesium carbonate, sodium bicarbonate, sodium carbonate, magnesium hydroxide, calcium hydroxide, magnesium oxide, and mixtures thereof. In one embodiment, a tablet composition is provided, comprising: about 30% to about 35% by weight of SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate. In one embodiment, a tablet composition is provided, comprising: about 30 wt % to about 35 wt % of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; wherein the SDD has an average particle size of about 5 µm to about 113 µm in diameter; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate. In one embodiment, a tablet composition is provided, comprising: about 30% by weight to about 35% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder consisting of a polymer selected from PVP-VA and PVP; wherein the SDD has a diameter of about 5 µm to about 113 μm average particle size; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate. In one embodiment, a tablet composition is provided, comprising: about 30% to about 35% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate SDD; and about 0.5 mg to about 60 mg of the SDD. mg amount (based on free acid); and the remainder is composed of a polymer selected from PVP-VA and PVP; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate. In one embodiment, a tablet composition is provided, comprising: about 30% to about 35% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate SDD; and about 0.8 mg to about 45 mg of the SDD. mg amount (based on the free acid); and the remainder is composed of a polymer that is PVP-VA; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate. In one embodiment, a tablet composition is provided, comprising: about 30% to about 35% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate SDD; and about 0.5 mg to about 60 mg of the SDD. mg (based on the free acid); and the remainder is composed of a polymer that is PVP-VA; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate; in an amount of about 1 mg to about 100 mg. In one embodiment of the tablet composition, the SDD has an average particle size of about 5 μm to about 113 μm in diameter; and the pH adjuster is sodium carbonate. In one embodiment of the tablet composition, the composition further comprises: a super disintegrant selected from the group consisting of croscarmellose sodium and copovidone; and a lubricant. In one embodiment of the tablet composition, the super disintegrant is copovidone in an amount of about 2 mg to about 250 mg; and the lubricant is magnesium stearate in an amount of about 0.1 mg to about 10 mg. In one embodiment, disclosed herein are tablet compositions selected from the group consisting of Composition 1 (Comp. 1), Composition 2 (Comp. 2), Composition 3 (Comp. 3), Composition 4 (Comp. 4), Composition 5 (Comp. 5), Composition 6 (Comp. 6), Composition 7 (Comp. 7), and Composition 8 (Comp. 8), as shown in the following table, wherein the amount of each component of a particular composition is shown as a target amount for that composition. In one embodiment, GLP1RA-Ca is used as the active ingredient, and the amount of each GLP1RA in the composition is based on the free acid. As will be appreciated by those skilled in the art of pharmaceutical formulation, the amount of one or more ingredients of a composition can be varied within certain limits while maintaining the desired properties of the composition. In addition, when the amount of one ingredient is varied, the amount of one or more other ingredients can be adjusted accordingly within certain ranges to keep the total weight of the composition constant and maintain the desired properties of the composition. In one embodiment of a particular composition shown in the table above, the amount of each ingredient is within the respective variable A range of the target amount, as indicated in parentheses, while maintaining the desired properties of the corresponding composition. In one embodiment of a particular composition shown in the table above, the amount of each ingredient is within the respective variable B range of the target amount, as indicated in parentheses, while maintaining the desired properties of the corresponding composition. In one embodiment, a method of preparing a composition as claimed herein comprises a spray drying dispersion process. In one embodiment, the present invention provides a tablet composition comprising: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; an amount of about 0.5 mg to about 75 mg based on the free acid; a pH adjuster selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, sodium carbonate hydrate, magnesium hydroxide, and mixtures thereof; an amount of about 1 mg to about 150 mg based on the free acid; mg amount; a super disintegrant selected from the group consisting of croscarmellose sodium and copovidone; in an amount of about 1 mg to about 250 mg; and a lubricant of magnesium stearate; in an amount of about 0.1 mg to about 10 mg. In one embodiment, the tablet composition of claim 21 comprises: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof in an amount of about 0.7 mg to about 60 mg based on the free acid; a pH adjuster selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, sodium carbonate hydrate, magnesium hydroxide, and mixtures thereof; and about 2 mg to about 100 mg; a super disintegrant selected from the group consisting of croscarmellose sodium and copovidone in an amount of about 2 mg to about 200 mg; and a lubricant of magnesium stearate in an amount of about 0.1 mg to about 2.5 mg. In one embodiment, the present invention provides a tablet composition, wherein the composition comprises: SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and a pH adjuster. In one embodiment, the present invention provides a tablet composition comprising: about 30% to about 35% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and SDD in an amount of about 0.5 mg to about 75 mg of the free acid. mg; and the remainder of the SDD is composed of PVP-VA; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate; in an amount of about 1 mg to about 150 mg. In one embodiment, the present invention provides a tablet composition comprising: about 30% to about 35% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or its 0.5% Ca hydrate SDD; and about 0.7 mg to about 60 mg of SDD as the free acid. mg; and the remainder of the SDD consists of PVP-VA; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate; in an amount of about 5 mg to about 100 mg. In one embodiment, the present invention provides a tablet composition comprising: about 30% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or its 0.5% Ca hydrate; and about 1.7 mg to about 250 mg of SDD. and the remainder of the SDD consists of PVP-VA; wherein the SDD is from about 2 wt % to about 25 wt % of the total tablet weight; and a pH adjuster that is sodium carbonate; in an amount from about 6 mg to about 100 mg; wherein the pH adjuster is from about 5 wt % to about 15 wt % of the total tablet weight. In one embodiment, the present invention provides a tablet composition comprising: about 30% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate SDD; about 1.7 mg to about 14.3 mg of and the remainder of the SDD consists of PVP-VA; wherein the SDD is from about 2 wt % to about 16.9 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; in an amount of about 6.8 mg; wherein the pH adjuster is about 8 wt % of the total tablet weight. In one embodiment, the present invention provides a tablet composition comprising: about 30% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate SDD; about 16.7 mg to about 120 mg of the tablet composition; and the remainder of the SDD consists of PVP-VA; wherein the SDD is about 19.5 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; in an amount of about 6.8 mg to about 49.2 mg; wherein the pH adjuster is about 8 wt % of the total tablet weight. In one embodiment, the present invention provides a tablet composition comprising: about 30% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate SDD; about 150 mg to about 250 mg of the tablet composition; and the remainder of the SDD consists of PVP-VA; wherein the SDD is about 21 wt % to about 25 wt % of the total tablet weight; and a pH adjuster that is sodium carbonate; in an amount of about 57.1 mg to about 80 mg; wherein the pH adjuster is about 8 wt % of the total tablet weight. In one embodiment of the tablet composition described above, the SDD has an average particle size of about 5 μm to about 113 μm in diameter. In one embodiment, the tablet composition further comprises a super disintegrant selected from the group consisting of croscarmellose sodium and copovidone. In one embodiment, the tablet composition comprises: the super disintegrant being copovidone in an amount of about 8.5 mg to about 170 mg; and the super disintegrant being about 10% to about 17% by weight of the total tablet weight. In one embodiment, the composition is a tablet composition, wherein the composition further comprises: a filler that is MCC; in an amount of about 67 mg to about 495 mg; wherein the filler is about 49.5 wt % to about 79.5 wt % of the total tablet weight. In one embodiment, the tablet composition further comprises: a lubricant that is magnesium stearate in an amount of about 0.4 mg to about 5 mg; wherein the lubricant is about 0.1% to about 1% by weight of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate SDD; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 19.5 wt % of the total tablet weight; is a pH adjuster of sodium carbonate; wherein the pH adjuster is about 8 weight % of the total tablet weight; is a super disintegrant of copovidone; wherein the super disintegrant is about 17 weight % of the total tablet weight; and is a filler of MCC; wherein the filler is about 55 weight % of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 25 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; wherein the pH adjuster accounts for approximately 8 wt % of the total tablet weight. is a super disintegrant of copovidone; wherein the super disintegrant is about 17% by weight of the total tablet weight; and is a filler of MCC; wherein the filler is about 49.5% by weight of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 21 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; wherein the pH adjuster accounts for approximately 8 wt % of the total tablet weight. is a super disintegrant of copovidone; wherein the super disintegrant is about 17% by weight of the total tablet weight; and is a filler of MCC; wherein the filler is about 53.5% by weight of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate SDD; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 16.9 wt % of the total tablet weight; is a pH adjuster of sodium carbonate; wherein the pH adjuster is about 8 weight % of the total tablet weight; is a super disintegrant of copovidone; wherein the super disintegrant is about 10 weight % of the total tablet weight; and is a filler of MCC; wherein the filler is about 64.6 weight % of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate SDD; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 11.8 wt % of the total tablet weight; is a pH adjuster of sodium carbonate; wherein the pH adjuster is about 8 weight % of the total tablet weight; is a super disintegrant of copovidone; wherein the super disintegrant is about 10 weight % of the total tablet weight; and is a filler of MCC; wherein the filler is about 69.7 weight % of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 9.8 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; wherein the pH adjuster accounts for approximately 8 wt % of the total tablet weight. is a super disintegrant of copovidone; wherein the super disintegrant is about 10 wt % of the total tablet weight; and is a filler of MCC; wherein the filler is about 71.7 wt % of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 3.9 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; wherein the pH adjuster accounts for approximately 8 wt % of the total tablet weight. is a super disintegrant of copovidone; wherein the super disintegrant is about 10 wt % of the total tablet weight; and is a filler of MCC; wherein the filler is about 77.6 wt % of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 3.2 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; wherein the pH adjuster accounts for approximately 8 wt % of the total tablet weight. is a super disintegrant of copovidone; wherein the super disintegrant is about 10 wt % of the total tablet weight; and is a filler of MCC; wherein the filler is about 78.3 wt % of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 2.7 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; wherein the pH adjuster accounts for approximately 8 wt % of the total tablet weight. is a super disintegrant of copovidone; wherein the super disintegrant is about 10 weight % of the total tablet weight; and is a filler of MCC; wherein the filler is about 78.8 weight % of the total tablet weight. In one embodiment, a tablet composition is provided, wherein the composition comprises: approximately 30 wt % of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca hydrate SDD; and the remainder of the SDD is composed of PVP-VA; wherein the SDD accounts for approximately 2.0 wt % of the total tablet weight; and a pH adjuster of sodium carbonate; wherein the pH adjuster accounts for approximately 8 wt % of the total tablet weight. is a super disintegrant of copovidone; wherein the super disintegrant is about 10 weight % of the total tablet weight; and is a filler of MCC; wherein the filler is about 79.5 weight % of the total tablet weight. In one embodiment, the tablet composition as described above further comprises a lubricant that is magnesium stearate; wherein the lubricant is about 0.5% by weight of the total tablet weight. In one embodiment, the composition as described above further comprises an immediate release coating. In one embodiment, the tablet composition as described above further comprises an enteric coating on the immediate-release coating. Pharmaceutical compositions using amorphous forms of active substances have been prepared using spray-dried dispersions (SDD) to develop crystalline forms of poorly soluble drugs. However, this SDD approach is complicated by the presence of polymeric functional excipients that may be required to maintain the drug in an amorphous state. Providing a composition with acceptable pharmacokinetic properties and a desired food effect profile can be particularly challenging for molecules with a strongly pH-dependent solubility profile. GLP1RA and GLP1RA-Ca exhibit this pH-dependent solubility profile. Weak acids can present challenges in ensuring that dissolution of the active substance is achieved in the desired portion of the gastrointestinal tract (specifically, the stomach), where low pH can slow the dissolution of weakly acidic drugs. When added to the tablet compositions described herein, certain excipients can become unstable. In one embodiment, the excipient is stabilized in a tablet composition with a pH adjuster. As used herein, pH adjusting agents refer to inorganic basic salts, including but not limited to calcium carbonate, magnesium carbonate, sodium bicarbonate, sodium carbonate, magnesium hydroxide, calcium hydroxide, magnesium oxide, including both anhydrous and hydrated forms of the respective salts that enable a slight increase in pH during tablet disintegration and dissolution. In one embodiment, the GLP1RA or pharmaceutically acceptable salt composition comprises a pH adjuster that is sodium carbonate. In one embodiment, the GLP1RA or pharmaceutically acceptable salt composition comprises a pH adjuster that is sodium carbonate in its anhydrous form. In one embodiment, a composition comprises a GLP1RA or a pharmaceutically acceptable salt thereof, and a pH adjuster selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, magnesium hydroxide, and mixtures thereof. In one embodiment, a composition comprises a GLP1RA or a pharmaceutically acceptable salt thereof, and a pH adjuster selected from the group consisting of calcium carbonate, anhydrous calcium carbonate, sodium bicarbonate, anhydrous sodium bicarbonate, sodium carbonate, anhydrous sodium carbonate, magnesium hydroxide, and anhydrous magnesium hydroxide. In one embodiment, the tablet composition comprising a GLPIRA or a pharmaceutically acceptable salt thereof and a pH adjuster is uncoated. In one embodiment, the tablet composition is formulated as an immediate-release (IR) dosage form that releases the GLP1RA or a pharmaceutically acceptable salt thereof in the gastric cavity. Excessive pH modifiers in the tablet may affect the absorption of co-administered drugs, whose absorption is pH-sensitive. In one embodiment, the pH modifier is present in a sufficiently low amount so that it does not increase the overall gastric pH during dissolution, but is sufficient to promote the dissolution of the GLP1RA or a pharmaceutically acceptable salt thereof. An immediate-release dosage form with a sufficiently low amount of pH modifier may be desirable to minimize the potential for gastric pH elevation and drug-drug interactions (DDIs) with co-administered drugs. In one embodiment, a tablet composition comprising a GLPIRA or a pharmaceutically acceptable salt thereof and a pH adjuster is coated with an immediate release coating. As used herein, the term "immediate-release coating" refers to a coating that is primarily intended for aesthetic purposes and is not intended to alter the disintegration and / or dissolution of the tablet. As used herein, suitable immediate-release coatings can be selected from known coatings, such as, but not limited to, Opadry® Clear (03K19229) (Colorcon Inc). As is common with moisture-sensitive SDD formulations, protection from moisture is required to ensure product functionality and aesthetics throughout the shelf life. This protection can be achieved through packaging and by utilizing coating materials that minimize the hygroscopicity of the tablet. One known immediate-release coating with this functionality is Opadry® ambII (Colorcon). In one embodiment, a composition comprises a GLP1RA or a pharmaceutically acceptable salt thereof; a pH adjuster; and an immediate-release coating. In one embodiment, a tablet composition comprising a GLP1RA or a pharmaceutical salt thereof and a pH adjuster is formulated as a delayed-release (DR) dosage form further comprising an enteric coating. Compositions further comprising an enteric coating can be released in the intestine at a pH of 5.5 or greater. The GLP1RA or a pharmaceutically acceptable salt thereof may need to be released in the intestine to limit the risks potentially associated with the presence of a pH adjuster in the tablet. DR compositions can minimize potential food effects and may have other beneficial effects on pharmacokinetic profiles, such as, but not limited to, overall exposure and modulation of Cmax. As used herein, "enteric coating" means a functional coating that is intended to prevent disintegration and / or dissolution of the tablet in the gastric environment, but dissolves in the intestinal environment. In one embodiment, a composition comprises a GLP1RA or a pharmaceutically acceptable salt thereof; a pH adjuster; and an enteric coating. In one embodiment, a tablet composition comprises a GLP1RA or a pharmaceutically acceptable salt thereof; a pH adjuster; and a superdisintegrant. In one embodiment, a tablet composition comprises a GLP1RA or a pharmaceutically acceptable salt thereof; a pH adjuster; a superdisintegrant; and a lubricant. In one embodiment, a tablet composition comprises a GLP1RA or a pharmaceutically acceptable salt thereof; a pH adjuster; a superdisintegrant; and an enteric coating on the tablet. In one embodiment, a tablet composition comprises a GLP1RA or a pharmaceutically acceptable salt thereof; a pH adjuster; a superdisintegrant; and an immediate-release coating on the tablet. As used herein, the terms "superdisintegrant" and "disintegrant" are used interchangeably and refer to excipients that promote the desired dissolution of a GLP1RA or its pharmaceutical salt, including, but not limited to, croscarmellose sodium and copovidone. The term "superdisintegrant" refers to an excipient that preferably promotes the dissolution of a GLP1RA or its pharmaceutical salt within 30 to about 60 minutes. In one embodiment, the tablet composition comprises a GLP1RA or its pharmaceutical salt; a pH adjuster; and a superdisintegrant selected from the group consisting of croscarmellose sodium and copovidone. In one embodiment, the present invention provides a tablet composition comprising a GLP1RA or a pharmaceutical salt thereof; a pH adjuster; and povidone. In one embodiment, a desired tablet composition provides reliable PK performance in a patient-friendly dosage form. A patient-friendly tablet composition dosage form with an acceptable size is desired to facilitate swallowing during daily administration, has minimal potential for drug-drug interactions (DDIs) with other concomitant medications, and has minimal usage restrictions, including minimizing food effects, avoiding restrictions on administration time, and avoiding restrictions on the volume of liquid used to assist swallowing. Tablet compositions can be released in the gastric compartment or intestinal compartment (intestine / enteric) via an erosion mechanism. The dosage forms of the present invention offer the potential for improved absorption / PK performance. The dosage forms provided herein can reduce undesirable drug interactions. Certain abbreviations are defined as follows: “cfm” means cubic feet per minute; “Cmax” means the maximum plasma concentration of the drug achieved in the test area after administration of the drug and before administration of the second dose; “DDI” means drug-drug interaction; “DR” means delayed release; “EtOH” means ethanol or ethyl alcohol; “FaSSiF” means fasted simulated intestinal fluid; “FaSSGF” means fasted simulated gastric fluid; "FeSSIF" refers to fed-state simulated intestinal fluid; "hr" refers to hours; "hrs" refers to multiple hours; "IR" refers to immediate-release; "PK" refers to pharmacokinetic; "MeOH" refers to methanol or methyl alcohol; "rpm" refers to revolutions per minute; "PVP-VA" refers to polyvinylpyrrolidone / vinyl acetate copolymer; "SDD" refers to spray-dried dispersion; "SIF" refers to simulated intestinal fluid; "T2D" refers to type 2 diabetes; "THF" refers to tetrahydrofuran; "USP" refers to the United States Pharmacopoeia; "wt%" refers to mass of material required / total mass; and XRPD refers to X-ray powder diffraction. As used herein, "prep" means formulation. Those skilled in the art can prepare 0.5 Ca spray-dried dispersion (SDD) formulations of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one under various process conditions and by varying equipment to produce materials with suitable quality and key characteristics. In one embodiment, GLP1RA or GLP1RA-Ca in an SDD formulation having a particle size suitable for isolation and further processing is amorphous as measured by XRPD, contains the desired weight % of drug (30%) and PVP-VA (70%), and is acceptably free of process-related impurities and excess residual solvent. In one embodiment, an amorphous solid dispersion can be used in the preparation process. In one embodiment, the particle size used to prepare the tablet composition is about 5 to about 113 μm. For the analysis in this article, capsules were prepared using conventional encapsulation methods. This application claims the benefit of U.S. Provisional Application Serial No. 63 / 340,595, filed May 11, 2022, under 35 U.S.C. §119(e), the disclosure of which is incorporated herein by reference. Preparation 1 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate Example 1 can be prepared as described in WO 18 / 056453. The title compound has alternative names. For example, it is also known as the hemi-calcium salt hydrate of orforglipron. Another name for the title compound is 1,2,4-oxadiazol-5(2H)-one, 3-[(1S,2S)-1-[2-[[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2,3-dihydro-2-oxo-1H-imidazol-1-yl]-2,4,6,7-tetrahydro-4-methyl-5H-pyrazolo[4,3-c]pyridin-5-yl]carbonyl]-5-[(4S)-tetrahydro-2,2-dimethyl-2H-pyran-4-yl]-1H-indol-1-yl]-2-methylcyclopropyl]-calcium salt (2:1) hydrate. Preparation 2 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate SDD preparation 30% 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate SDD was prepared by dissolving 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate (8.7 g, 92% potency) and PVP-VA (also known as copovidone, CAS No. 25086-89-9) (18.7 g) in EtOH (200 mL) at room temperature. After the solids were dissolved, the solution was spray dried on a conventional spray dryer with a pressure nozzle. The parameters in Table 1 below were used to produce the dispersion using a laboratory scale spray dryer. Spray drying could begin when the spray dryer temperature was above 33°C. The material was collected and dried under vacuum at 50°C overnight to give the title compound (21.99 g, 7.0 g, 92% potency, 80% recovery) and the material was observed by microscopy to be microscopically non-birefringent particles with a diameter of approximately 5 to 25 µm. SDD Parameters Table 1 Preparation 3 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca Hydrate SDD Formulation: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5% Ca Hydrate was dissolved in EtOH and denatured with MeOH (5% v / v or w / w). A 20% w / w solids solution was prepared, with 30% w / w of the solids consisting of the title compound (based on the free acid) and the remainder consisting of PVP-VA. This converted to 6% title compound (based on free acid), 14% PVP-VA, and 80% denatured EtOH SDA-3A—all fractions are expressed in w / w. After spray drying, the resulting solid consisted of a 30% w / w portion of the solids consisting of the title compound (based on free acid) and the remainder consisting of PVP-VA. The % values ​​are shown in Table 2 below. Formulation of Formulation 3 SDD Table 2 Once the solution is prepared, it is pumped into the spray dryer, where it is atomized upon entry. Heated drying gas flows into the atomized liquid at the top of the spray drying chamber at a ratio of approximately 0.044 kg / kg spray solution: drying gas. The inlet temperature is adjusted to provide an outlet temperature of 35 to 45°C. Solids formed in the spray dryer are collected from a cyclone and a filter cover above the gas stream. The gas passing through the condenser is maintained at -3°C to remove the solvent (to a dew point of -3°C). The gas is then heated to the inlet temperature and passed back to the spray dryer. Formulation 4 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca Hydrate Capsule Formulation Capsules were prepared by first adding sodium bicarbonate (600 mg) to a size 0 hypromellose capsule, followed by the addition of Formulation 3 SDD (54 mg). Quantitative Capsule Composition, Formulation 4 Table 3 Preparation 5 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca Hydrate Tablet Formulation Core Tablet Composition Preparation To prepare the core tablet, 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxan-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazol-5-yl)-2-oxoimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridine-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate (13.3% w / w) SDD and excipients (as described in Examples 1 to 7) (except magnesium stearate) were sieved through a 600 µm sieve before use. The materials were added to a 1000 mL container and mixed with a mixer at 32 rpm for approximately 10 minutes. The mixture was passed through a 600 µm screen and mixed a second time at 32 rpm for approximately 10 minutes. Magnesium stearate was added, and the mixture was mixed at 32 rpm for approximately 3 minutes. The mixture was compacted using a 14.10 x 7.75 mm oval tablet tool on a single-station tablet press to produce tablets (400.0 mg) with a hardness of 30 kP. Tablet compositions were prepared substantially as described above, using the parameters of Tables 4 to 10 below, to prepare corresponding Examples 1 to 7 (compositions T1, T2, A, B, C, D, and E). Examples 1 to 7 each comprised an IR coating substantially as described herein and, for the tablets in Examples 1 to 6, additionally comprised an enteric coating. The tablet of Example 7 comprised only the IR coating. Example 1 Tablet Composition T1 Table 4 Example 2 Tablet Composition T2 Table 5 Example 3 Tablet Composition A Table 6 Example 4 Tablet Composition B Table 7 Example 5 Tablet Composition C Table 8 Example 6 Tablet Composition D Table 9 Example 7 Tablet Composition E Table 10 * Numbers in ( ) indicate the theoretical target of GLP1RA. Immediate Release Coatings for Examples 1 to 7 Immediate Release Tablet Coatings A film coat of an immediate release coating (such as Opadry® Clear (03K19229) (Colorcon Inc)) was applied to the core tablet compositions prepared substantially as described in each of Examples 1 to 7 to a target weight gain of 3% by weight (with an acceptable range of 2.5 to 3.5%). The tablets were coated using conventional pan coating equipment and coating conditions recommended by the supplier, using water as the base for the spray suspension. Examples 1 to 7 were coated using this immediate release coating. Example 8 Delayed-Release Tablet Composition Coating (Enteric Coating) The tablet compositions of Examples 1 to 6 were coated with Opadry® Clear essentially as described above. The Opadry® Clear-coated tablets were further enteric-coated with Acryl-EZE® (93A18597) (Colorcon Inc) and PEG 8000 as a plasticizer at 8% by weight relative to Acryl-EZE to a target weight gain of 6.75% by weight (with an acceptable range of 6.25 to 7.25%). The tablets were coated using conventional pan coating equipment using the coating conditions recommended by the supplier, using water as the base for the spray suspension. Example 9 Enteric Coated Tablet Composition - Enteric coated tablets were prepared using tablet compositions substantially as described in Examples 1 to 6, except that the weight percent of sodium carbonate was adjusted and compensated for by adjusting the microcrystalline cellulose content. Tablets were coated to a target weight gain of 3% using Opadry® 03K19229 (Colorcon Inc.) using a spray suspension containing 8 weight percent solids. Tablets were coated using a benchtop pan coater with a 0.8 mm orifice nozzle spray gun equipped with an anti-spot cap, an inlet air flow of 30 cfm, an inlet air temperature of 70°C, a spray suspension rate of 2.3 g / min, an atomization pressure of 1.5 bar, a pattern air pressure of 0.25 bar, and a pan speed of 32 rpm. The tablets were then enteric coated using Acryl-EZE 93A18597 (Colorcon Inc.) using the same equipment to a target weight gain of approximately 6.5%. An aqueous suspension of 20 wt% Acryl-EZE powder was prepared, with PEG-8000 added as a plasticizer at 8 wt% relative to the Acryl-EZE. Coating conditions were as follows: a 0.8 mm orifice spray gun with an anti-smear cap, an inlet airflow of 25 cfm, an inlet air temperature of 60°C, a spray suspension rate of 4.1 g / min, an atomization pressure of 1.5 bar, a pattern air pressure of 0.25 bar, and a disk speed of 35 rpm. Example 10 Quantitative IR Tablet Composition Table 11 Example 11 Alternative Tablet Composition with Croscarmellose Sodium Superdisintegrant Tablet 12 Example 12 Alternative Tablet Composition with Copovidone Superdisintegrant Tablet 13 Tablet compositions are prepared using these superdisintegrants in the formulations shown in Tables 11 and 12. All materials (except magnesium stearate) are added to an amber glass jar and mixed at 22 rpm for 10 minutes using a rotary diffusion mixer. The blend is passed through a No. 35 sieve and then remixed for 10 minutes. Magnesium stearate is passed through a No. 35 sieve and added to the jar and blended for 5 minutes. The blend is compacted using a modified oval tool using a single-station tablet press with a 6 kN compression force. The core tablets are coated to a 3% weight gain target using a spray suspension containing 8% by weight solids using Opadry® 03K19229 (Colorcon Inc.). The tablets were coated using a benchtop pan coater using a 0.8 mm orifice nozzle spray gun equipped with an anti-smear cap, an inlet airflow of 30 cfm, an inlet air temperature of 70°C, a spray suspension rate of 2.3 g / min, an atomization pressure of 1.5 bar, a pattern air pressure of 0.25 bar, and a pan speed of 32 rpm. The tablets were then enteric coated with Acryl-EZE 93A18597 (Colorcon Inc.) using the same equipment to a target weight gain of approximately 6.5%. An aqueous suspension of 20 wt% Acryl-EZE powder was prepared, with PEG-8000 added as a plasticizer at 8 wt% relative to Acryl-EZE. The coating conditions were as follows: 0.8 mm orifice nozzle spray gun with anti-spot cap, inlet air flow of 25 cfm, inlet air temperature of 60°C, spray suspension rate of 4.1 g / min, atomization pressure of 1.5 bar, pattern air pressure of 0.25 bar and disk speed of 35 rpm. Example 13 Tablet Composition 400 mg Total Weight Tablets Total Weight Tablets (400 mg) were prepared using the percentages in Table 14. Tablets were prepared with an immediate release coating and then enteric coated substantially as described in Example 9. Table 14 Example 14 Tablet Compositions 9 to 30 Core tablet compositions 9 to 30 (Comp. 9 to Comp. 30) were prepared using the percentages in the table below and the method described earlier. The core tablets were prepared, coated with an immediate release coating, and optionally further coated with an enteric coating substantially as described in Example 9. Particle size measurement (SDD) was determined by laser diffraction using wet dispersions on a Malvern Mastersizer 3000 (Malvern Instruments Ltd., UK) equipped with a Hydro MV (Medium Volume) liquid dispenser. Optical model: Mie model, opacity limits: 5 to 30%, universal model. Volume-based distributions were measured and quantiles (D10, D50, D90) were reported. The SDDs of Formulations 2 and 3 had an average particle size of about 40 to about 65 μm in diameter, or more specifically, about 40 to about 50 μm in diameter, as measured by the above method. Solubility Study 24-hour water solubility of crystalline GLP1RA-Ca at 25°C Table 15 *Not measured One embodiment of the present invention is an oral tablet formulation comprising an amorphous SDD of GLP1RA-Ca. GLP1RA-Ca in its crystalline form has poor water solubility, as shown in Table 15. Amorphous SDD of GLP1RA-Ca using PVP-VA as a carrier polymer has been shown to provide improved hydrophilicity and solubility as compared to crystalline GLP1RA-Ca (Table 16). 24-hour water solubility of Formulation 3 SDD at 25°C Table 16 Table 17: 24-hour water solubility of formulation 3 SDD at 37°C As seen in Tables 16 and 17, Formulation 3 has pH-dependent solubility. With a pKa of 5.1, it was expected that the solubility of the drug would begin to increase at pH values ​​close to the pKa and that dissolution performance would improve at pH values ​​at or above the pKa. To test this, capsules containing SDD and sufficient sodium bicarbonate to raise the pH of the acidic dissolution medium to around the pKa were evaluated in dissolution experiments compared to tablets containing much less pH adjusting agent. The quantitative formulations are shown in Table 11 for tablets and in Table 3 for capsules. Dose Dissolution Studies The dosage form was evaluated in a two-stage dissolution study consisting of an acid stage (500 mL of 0.0133N HCl / 8.12 mM NaCl) for 1 hour, followed by the addition of concentrated FaSSIF (400 mL) to convert the medium to the pH and composition of typical fasting intestinal fluid. To prepare 1 L of each concentrated FaSSiF, anhydrous sodium phosphate dibasic (5.714 g), anhydrous sodium phosphate monobasic (2.906 g), and NaCl (12.354 g) were added along with water to make up 1 L and mixed thoroughly. The pH should be approximately 7.0. SIF powder (5.6 g) (FaSSIF / FeSSIF / FaSSGF powder (Biorelevant)) was added. The assay was run using a USP II dissolution apparatus at 100 rpm. Aliquots were withdrawn, filtered through a 0.22 micron filter, diluted 1:1 with MeOH to prevent drug precipitation, and analyzed by HPLC. It was unexpectedly found that the IR tablet performed better in the gastric phase than the capsule formulation, although the capsule formulation raised the media pH to greater than 5 due to the large amount of sodium bicarbonate and the tablet had no effect on the media pH, which remained at a pH of 2. Comparison of dissolution of Example 10 tablets and Formulation 4 capsules. Table 18 StDev refers to standard deviation. Alternative dissolution conditions were also used to compare capsule formulation 4 and IR tablet composition Example 7. The conditions used were USP II paddles at 100 rpm using 50 mM pH 6.8 phosphate buffer using 2% sodium lauryl sulfate as the dissolution medium. Samples were analyzed by HPLC. Surprisingly, despite the presence of significant amounts of sodium bicarbonate, which should promote dissolution of the SDD from the capsules, the IR tablets again released more rapidly than the capsules achieving 100% release within 30 minutes, while the capsules achieved only 35% release at 30 minutes and did not achieve >90% release until approximately 75 minutes. preparation 4 Table 19: Alternative dissolution conditions for capsules Composition Example 7 Alternative Dissolution Conditions Table 20 The pH adjuster in both IR and DR tablets promotes dissolution of acidic drugs by increasing their local or micro pH as the tablet disintegrates. Enteric tablets were used to determine the required pH adjuster content for enteric tablet compositions. Enteric-coated tablet Example 9 was tested in a two-stage dissolution study using a USP II apparatus with a paddle speed of 100 rpm. The acid challenge phase was first conducted in pH 4.5 sodium acetate buffer (500 mL) for 2 hours, after which the tablets were removed and placed in FaSSiF (Biorelevant) (500 mL). An aliquot was withdrawn, filtered through a 0.22 μm filter, diluted 1:1 with MeOH to prevent drug precipitation, and analyzed by HPLC. Surprisingly, very high levels of pH adjuster (20 wt% in the tablet) resulted in poorer dissolution behavior for the DR tablets compared to lower levels. Additionally, the optimum level of peak and more sustained dissolution was achieved at approximately 10 wt% sodium carbonate. Dissolution Study of Delayed-Release Tablets Table 21 nm = not measured Tablets from Examples 11 and 12 were tested in a two-stage dissolution test using a USP II apparatus at a paddle speed of 100 rpm. The acid challenge phase consisted of a 2-hour in pH 4.5 sodium acetate buffer (500 mL), after which the tablets were removed and placed in FaSSiF (Biorelevant) (500 mL). An aliquot was withdrawn, filtered through a 0.22 μm filter, diluted 1:1 with MeOH to prevent drug precipitation, and analyzed by HPLC. Surprisingly, it was found that croscarmellose sodium, as used in Example 11, did not provide the desired release profile, whereas copovidone, as used in Example 12, did. Tablet 2-stage dissolution test Table 22 In another embodiment, the release rate from the enteric-coated tablets can be controlled to affect specific aspects of the PK profile, such as Cmax or trough plasma concentrations, as these may be beneficial to the patient to aid tolerability and / or efficacy. Controlled release from tablets is typically achieved using rate-controlling polymers such as hydroxypropyl cellulose, as in hydrophilic sustained-release matrix tablets. The challenge with using hypromellose or similar polymers is that they tend to act over several hours via diffusion and / or erosion mechanisms. Without maximizing drug concentration in the intestinal lumen, this time span can be too long for low-permeability molecules, which can lead to reduced flux across the intestinal epidermis and subsequent reduced absorption if the drug is released gradually over many hours. Surprisingly, it was discovered that controlling the amount of superdisintegrant in an enteric-coated dosage form allows for a significant degree of control over the release rate, with the time required for complete release being within 30 minutes. Tablets T1 and T2 were evaluated in a 2-stage dissolution test substantially similar to that described above, except that the pH 4.5 sodium acetate acid stage was set for 1 hour before the tablets were transferred to FaSSiF (Biorelevant). The results are shown in Table 23. Surprisingly, a simple adjustment of the disintegrant content can achieve a controlled release level in FaSSiF. Tablets T1 and T2 Two-stage dissolution study at pH 4.5 Table 23 Another lever for regulating the release of the drug from the intestinal lozenge is to change the amount of sodium carbonate. The lozenges were subjected to dissolution in a pH 6.8 phosphate buffer with 2% sodium lauryl sulfate as described herein. The results of this study confirmed that there is synergy between the content of disintegrant and the amount of pH regulator that can be used to control the release of the drug from the lozenge. In addition, controlled release was modeled within the desired range of 30 minutes to no more than 3 hours to approximate in vivo transit time through the small intestine, where it is expected that most drug absorption will occur. The results are shown in Table 24. Table 24: Dissolution time of tablets T1, T2, A, B, C, and D at pH 6.8 Clinical Trial A multiple ascending dose study was conducted to characterize and compare the pharmacokinetics (PK) of the prototype formulations of Formulation 4 (capsules) Example 1 (DR tablet composition T1 with an enteric coating as prepared in Example 9, hereinafter referred to as T1 DR tablet) and Example 7 (IR tablet composition E with an immediate-release coating, hereinafter referred to as E IR tablet). The study was conducted in two parts: A and B. Part A evaluated the safety, tolerability and PK of multiple oral doses of the GLP1RA formulation prototypes T1 and E in healthy participants relative to the reference capsule formulation 4. The dose titration period was from day 1 to day 18, in which participants received increasing doses of GLP1RA in capsules for dose titration. During treatment, the dose escalation was every 6 days and reached a maximum dose of 16 mg GLP1RA once daily (QD) on day 19. On days 19 to 24, participants received the reference capsule formulation 4 (16 mg QD) and then entered the trial period of days 25 to 36. During trial period-1, participants were administered the GLP1RA prototype tablet (16 mg QD) formulation according to their randomized group. Participants were then crossed over to period-2 on day 31 and received the second prototype tablet (16 mg QD) on day 36. Table 25. Geometric means (geometric CV%) of plasma pharmacokinetic parameters of GLP1RA after single and multiple oral doses of GLP1RA in healthy male and female participants Abbreviations: AUC(0-24) = area under the curve from time 0 to 24 hours after dosing; Cmax = maximum observed concentration; Frel AUC(0-24) = relative bioavailability based on AUC(0-24); Frel Cmax = relative bioavailability based on Cmax; h = hours; N / A = not applicable The results of Part A indicate that the mean peak and total exposure levels of T1 for the 16 mg DR tablets (as measured by Cmax and AUC(0-24)) were approximately 67% and 50% higher, respectively, than those for the 16 mg reference formulation 4 capsules. These increases were statistically significant at the 10% significance level (p < .001 for both Cmax and AUC(0-24)). Similarly, for the 16 mg tablet E IR tablet, mean peak and total exposure (as measured by Cmax and AUC(0-24)) were approximately 47% and 41% higher, respectively, than those for the 16 mg reference capsule. These increases were statistically significant at the 10% significance level (p = .007 and p < .001 for Cmax and AUC(0-24), respectively). Part B further evaluated Tablet E IR Tablet with respect to food effects and DDI effects using a co-administered proton pump initiator (PPI). As in Part A, treatment escalation occurred every 6 days during the titration period and reached a maximum dose of 16 mg QD on Day 19. Treatment was then performed using GLP1RA in a fasting or fed state and in a fasting state using a co-administered PPI. Each option began with a 6-day baseline period (16 mg QD) using Tablet E IR Tablet as a reference, followed by two 6-day test periods (16 mg QD). Table 26: Geometric means (geometric CV%) of plasma pharmacokinetic parameters of GLP1RA after single and multiple oral doses of GLP1RA to healthy male and female participants Abbreviations: AUC(0-24) = area under the curve from time 0 to 24 hours after dosing; Cmax = maximum observed concentration; Frel AUC(0-24) = relative bioavailability based on AUC(0-24); Frel Cmax = relative bioavailability based on Cmax; h = hours; N / A = not applicable The results of Part B indicated that the mean peak and total exposures (as measured by Cmax and AUC(0-24)) for 16 mg E IR Tablets fed were comparable to those for 16 mg E IR Tablets fasted (p=.39 and p=.66 for Cmax and AUC(0-24), respectively) (i.e., fed exposures for Cmax and AUC(0-24), respectively, were within 11% and 4% of fasting exposures). Mean peak and total exposures (as measured by Cmax and AUC(0-24)) for the 16 mg Tablet E IR Tablet and PPI were also comparable (i.e., 6% lower and 6% higher for Cmax and AUC(0-24), respectively) to those for the 16 mg IR Tablet Composition E (p=.65 and p=.57 for Cmax and AUC(0-24), respectively). Although the present invention has been described in considerable detail with reference to certain aspects thereof, other versions are possible. The embodiments disclosed herein are for illustrative purposes only and various modifications of these embodiments and further embodiments in addition to those shown and described herein will become apparent to those skilled in the art from the entire contents of this specification.

Claims

1. A tablet composition comprising: a spray-dried dispersion (SDD) of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; and a pH adjuster.

2. The tablet composition of claim 1, wherein the pH adjuster is selected from the group consisting of: calcium carbonate, magnesium carbonate, sodium bicarbonate, sodium carbonate, magnesium hydroxide, calcium hydroxide, magnesium oxide, and mixtures thereof.

3. The tablet composition of claim 2, wherein the pH adjuster is selected from the group consisting of: calcium carbonate, sodium bicarbonate, sodium carbonate and magnesium hydroxide.

4. The tablet composition of claim 1, wherein the pH adjuster is selected from the group consisting of: anhydrous calcium carbonate, anhydrous sodium bicarbonate, anhydrous sodium carbonate and anhydrous magnesium hydroxide.

5. The tablet composition of claim 3, wherein the pH adjuster is sodium carbonate.

6. The tablet composition of claim 4, wherein the pH adjuster is anhydrous sodium carbonate.

7. The tablet composition of any one of claims 1 to 6, wherein the composition comprises: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; a pH adjuster; and a superdisintegrant.

8. The tablet composition of claim 7, wherein the superdisintegrant is selected from the group consisting of cross-linked sodium carboxymethyl cellulose and copovidone.

9. The tablet composition of claim 8, wherein the superdisintegrant is copovidone.

10. The tablet composition of any one of claims 1 to 6, wherein the composition comprises: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; a pH adjuster; a superdisintegrant; and a lubricant.

11. The tablet composition of claim 10, wherein the lubricant is magnesium stearate.

12. The tablet composition of any one of claims 1 to 6 further comprises an instant-release coating.

13. The tablet composition of any one of claims 1 to 6 further comprises an enteric coating.

14. The tablet composition of any one of claims 1 to 6, wherein the 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one salt is: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate.

15. The tablet composition of any one of claims 1 to 6, wherein the 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazine The oxadiazol-5-one or its pharmaceutically acceptable salt is 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; its amount based on free acid is about 0.7 to about 50 mg per tablet composition.

16. The tablet composition of claim 15, wherein the 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate is in an amount of about 48 mg / tablet.

17. The tablet composition of any one of claims 1 to 6, wherein the composition further comprises a PVP-VA polymer.

18. A tablet composition comprising: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; Its amount based on free acid is about 0.5 mg to about 75 mg; pH adjuster, which is selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, sodium carbonate hydrate, magnesium hydroxide and mixtures thereof; The amount is from about 1 mg to about 150 mg; a superdisintegrant selected from the group consisting of croscarmellose sodium and copovidone; the amount is from about 1 mg to about 250 mg; and a lubricant for magnesium stearate; the amount is from about 0.1 mg to about 10 mg.

19. The tablet composition of claim 18, wherein the composition comprises: 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; wherein the amount thereof, based on free acid, is from about 0.7 mg to about 60 mg; a pH adjuster selected from the group consisting of calcium carbonate, sodium bicarbonate, sodium carbonate, sodium carbonate hydrate, magnesium hydroxide, and mixtures thereof; wherein the amount thereof is about 2 mg to about 100 mg; a superdisintegrant selected from the group consisting of croscarmellose sodium and copovidone; in an amount of about 2 mg to about 200 mg; and a lubricant for magnesium stearate; in an amount of about 0.1 mg to about 2.5 mg.

20. The tablet composition of claim 1, wherein the composition comprises: about 30% to about 35% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or a pharmaceutically acceptable salt thereof; the amount of which, based on free acid, is about 0.5 mg to about 75 mg. mg; and the remainder of the SDD consists of PVP-VA; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate; in an amount of about 1 mg to about 150 mg.

21. The tablet composition of claim 1, wherein the composition comprises: about 30% to about 35% by weight of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or its 0.5 Ca hydrate, in an amount of about 0.7 mg to about 60 mg based on free acid. mg; and the remainder of the SDD consisting of PVP-VA; and a pH adjuster selected from the group consisting of sodium bicarbonate and sodium carbonate; in an amount of about 5 mg to about 100 mg.

22. The tablet composition of claim 20, wherein the composition comprises: about 30% by weight of SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one or its 0.5 Ca hydrate; in an amount of about 1.7 mg to about 250 mg. SDD; and the remainder of the SDD is composed of PVP-VA; wherein the SDD is about 2% to about 25% by weight of the total tablets; and is a pH adjuster of sodium carbonate; in an amount of about 6 mg to about 100 mg; wherein the pH adjuster is about 5% to about 15% by weight of the total tablets.

23. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; The amount is approximately 1.7 mg to approximately 14.3 mg SDD; and the remainder of the SDD consists of PVP-VA; wherein the SDD is approximately 2% by weight to approximately 16.9% by weight of the total tablet weight; and is a pH adjuster for sodium carbonate; The amount is approximately 6.8 mg; of which the pH adjuster accounts for approximately 8% of the total tablet weight.

24. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; in an amount of about 16.7 mg to about 120 mg. SDD; and the remainder of the SDD is composed of PVP-VA; wherein the SDD is about 19.5% by weight of the total tablets; and is a pH adjuster for sodium carbonate; in an amount of about 6.8 mg to about 49.2 mg; wherein the pH adjuster is about 8% by weight of the total tablets.

25. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; The amount is approximately 150 mg to approximately 250 mg SDD; and the remainder of the SDD consists of PVP-VA; wherein the SDD is approximately 21% to approximately 25% by weight of the total tablets; and is a pH adjuster for sodium carbonate; The amount is approximately 57.1 mg to approximately 80 mg; of which the pH adjuster is approximately 8% by weight of the total tablets.

26. The tablet composition of any one of claims 1 to 6, wherein the SDD has an average particle size of about 5 µm to about 113 µm in diameter; and the pH adjuster is sodium carbonate.

27. The tablet composition of claim 26, wherein the composition further comprises: a superdisintegrant selected from the group consisting of crosslinked sodium carboxymethyl cellulose and copovidone.

28. The tablet composition of claim 27, wherein: The superdisintegrant is copovidone, in an amount of about 8.5 mg to about 170 mg; wherein the superdisintegrant is about 10% to about 17% by weight of the total tablet weight.

29. The tablet composition of claim 28, wherein the composition further comprises: a filler for MCC; in an amount of about 67 mg to about 495 mg; wherein the filler is about 49.5% by weight to about 79.5% by weight of the total tablet weight.

30. The tablet composition of claim 29, wherein the composition further comprises: a lubricant of magnesium stearate; in an amount of about 0.4 mg to about 5 mg; wherein the lubricant is about 0.1% by weight to about 1% by weight of the total tablets.

31. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD is about 19.5% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 17% by weight of the total tablets; and a filler for MCC, comprising approximately 55% by weight of the total tablets.

32. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD constitutes about 25% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 17% by weight of the total tablets; and a filler for MCC, comprising approximately 49.5% by weight of the total tablets.

33. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD constitutes about 21% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 17% by weight of the total tablets; and a filler for MCC, comprising approximately 53.5% by weight of the total tablets.

34. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD constitutes about 16.9% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 10% by weight of the total tablets; and a filler for MCC, comprising approximately 64.6% by weight of the total tablets.

35. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD is about 11.8% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 10% by weight of the total tablets; and a filler for MCC, comprising approximately 69.7% by weight of the total tablets.

36. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD is about 9.8% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 10% by weight of the total tablets; and a filler for MCC, comprising approximately 71.7% by weight of the total tablets.

37. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD is about 3.9% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 10% by weight of the total tablets; and a filler for MCC, comprising approximately 77.6% by weight of the total tablets.

38. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD is about 3.2% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 10% by weight of the total tablets; and a filler for MCC, comprising approximately 78.3% by weight of the total tablets.

39. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD is about 2.7% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 10% by weight of the total tablets; and a filler for MCC, comprising approximately 78.8% by weight of the total tablets.

40. The tablet composition of claim 22, wherein the composition comprises: about 30% by weight of an SDD of 3-[(1S,2S)-1-[5-[(4S)-2,2-dimethyloxacyclohexane-4-yl]-2-[(4S)-2-(4-fluoro-3,5-dimethylphenyl)-3-[3-(4-fluoro-1-methylindazole-5-yl)-2-sideoxyimidazol-1-yl]-4-methyl-6,7-dihydro-4H-pyrazolo[4,3-c]pyridin-5-carbonyl]indol-1-yl]-2-methylcyclopropyl]-4H-1,2,4-oxadiazol-5-one 0.5 Ca hydrate; and the remainder of the SDD being composed of PVP-VA; wherein the SDD is about 2.0% by weight of the total tablets. The product is a pH adjuster for sodium carbonate, comprising approximately 8% by weight of the total tablets; a superdisintegrant for copovidone, comprising approximately 10% by weight of the total tablets; and a filler for MCC, comprising approximately 79.5% by weight of the total tablets.

41. The tablet composition of any one of claims 31 to 40, wherein the SDD has an average particle size of about 5 µm to about 113 µm in diameter.

42. The tablet composition of claim 40, wherein the SDD has an average particle size of about 40 µm to about 65 µm in diameter.

43. The tablet composition of any one of claims 18 to 25, 31 to 40 and 42, wherein the composition further comprises a lubricant of magnesium stearate; wherein the lubricant is about 0.5% by weight of the total tablets.

44. The tablet composition of claim 43, wherein the composition further comprises an instant-release coating.

45. The tablet composition of claim 44, wherein the composition further comprises an enteric coating on the instant-release coating.

46. ​​Use of a tablet composition of any one of claims 1 to 45 in the manufacture of a medicament for treating type 2 diabetes.

47. Use of a tablet composition of any one of claims 1 to 45 in the manufacture of a pharmaceutical preparation for weight management.