38 results about "LACTOSE MONOHYDRATE" patented technology

The invention provides a pharmaceutical composition containing fenerenone, which comprises the following components in percentage by weight: 1.0%-30.0% of fenerenone, 1.0%-5.0% of hydroxypropyl methylcellulose, 0.1%-1.0% of lauryl sodium sulfate, 5.0%-15.0% of polyvinylpolypyrrolidone and 0.5%-5.0% of sodium stearyl fumarate. The filler is microcrystalline cellulose and lactose monohydrate, a wet granulation process is adopted, the pharmaceutical composition has the characteristics of stable and rapid dissolution and rapid disintegration of the fenerenone, the process is simple, the production steps are simplified, the production efficiency is improved, and the cost is reduced.

The present invention relates to (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid of formula (I), preferably in the form of one of its salts or solvates or hydrates, preferably (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid monohydrate (I) of formula (IMI) or (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2- The present invention relates to a pharmaceutical dry powder formulation comprising {[3-chloro-4'-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid monohydrate (II) in combination with a lactose carrier comprising lactose monohydrate as a mixture of coarse and fine lactose, a process for producing such a pharmaceutical dry powder formulation, and its application for use in the treatment of cardiopulmonary disorders such as pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), and pulmonary hypertension (PH) associated with chronic lung diseases (group 3 PH), such as pulmonary hypertension in chronic obstructive pulmonary disease (PH-COPD) and pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP).

A stable pharmaceutical composition for oral administration, comprising sitagliptin and dapagliflozin, wherein said active ingredients are substantially free of contact from each other. A process for the preparation of a stable pharmaceutical dosage form for oral administration, comprising: Step 1: Weigh sitagliptin hydrochloride monohydrate and Microcrystalline Cellulose and sieve; Step 2: Wet granulation Step 3: Drying the granules in fluid bed dryer; Step 4: Sizing the granules; Step 5: Weigh dapagliflozin base, lactose monohydrate, and sodium starch glycolate, premix them and sieve; Step 6: Mixing granules from step 4 with excipients from step 5; Step 7: Lubrication with magnesium stearate, and Step 8: Compression of the homogeneous powder obtained from step 7 under controlled humidity in mono-layer tablets in a rotary tabletting machine. An alternative process comprising the following steps: Step 1: Weigh sitagliptin hydrochloride monohydrate and Microcrystalline Cellulose and sieve; Step 2: Wet granulation Step 3: Drying the granules in fluid bed dryer; Step 4: Sizing the granules; Step 5: Weigh dapagliflozin base, lactose monohydrate, and hydroxypropylcellulose and sieve; Step 6: Dry granulation of second active ingredient and the intra-granular excipients of step 5 and mix; Step 7: Sizing the slugs or flakes obtained from step 6; Step 8: Pre-Mixing the granules from step 4 and step 7; Step 9: Weigh sodium starch glycolate and sieve; Step 10: Mixing; Step 11: Lubrication with magnesium stearate, and Step 12: Compression of the homogeneous powder obtained from step 11.

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a pharmaceutical composition containing briracetam and a preparation method of the pharmaceutical composition. A pharmaceutical composition of the present application comprises a particle having an intra-particle phase and an extra-particle phase, the particle comprising, based on the total weight of the particle: Briracetam present in the intra-particle phase; the diluent in the particle inner phase is lactose monohydrate and lactose anhydrous in a weight ratio of 1: (0.5-2); a disintegrant present in the particulate inner phase and the particulate outer phase; and a lubricant present in the particulate outer phase. By controlling the weight ratio of the diluent types, the defect of easy sticking is improved under the condition that an adhesive beta-cyclodextrin is not added, and it is guaranteed that intermediate particles are tableted smoothly and are convenient to form; besides, by controlling the particle size of the active components and the dosage of the external phase disintegrating agent in the particles, the prepared briracetam preparation has the dissolution rate and bioequivalence equivalent to those of the original tablet, and the stability is superior to that of the original tablet.

The present disclosure provides oral dosage forms comprising about 8.75% w / w deuruxolitinib phosphate, about 50% to about 60% w / w microcrystalline cellulose, about 25% to about 35% w / w lactose monohydrate, about 3% to about 6% w / w polyvinylpyrrolidone, about 2% to about 4% w / w hydroxypropyl cellulose, about 0.25% to about 0.75% w / w colloidal silicon dioxide, and about 0.25% to about 0.75% w / w magnesium stearate.

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses a lercanidipine enalapril tablet and a preparation method thereof. The lercanidipine enalapril tablet takes lercanidipine hydrochloride and enalapril maleate as active ingredients, comprises auxiliary materials including lactose monohydrate, microcrystalline cellulose, cross-linked povidone, sodium bicarbonate, povidone and magnesium stearate, and is prepared by processes of separately granulating, mixing, tabletting, coating and the like. The lercanidipine enalapril tablet prepared by the invention is similar to a reference preparation in dissolution curve, uniform in content and good in stability.

The present invention relates to a pharmaceutical composition comprising avatrombopag maleate in amorphous or crystalline form, and at least one filler, wherein the filler is lactose monohydrate having a d(0.9) particle size of less than 250 µm. The present invention also relates to a simple and cost-effective process for preparing the pharmaceutical composition.

The application relates to a celecoxib capsule composition and belongs to the technical field of pharmaceutical preparations. The celecoxib capsule composition is prepared from the following components in percentage by weight: celecoxib 74.1%, lactose monohydrate 16.4%-17.4%, arginine 1.0%-2.0%, sodium dodecyl sulfate 3.0%, povidone (K30) 2.5%, cross-linked sodium carboxymethyl cellulose 1.0%, and magnesium stearate 1.0%. The problem that the dissolution curve of the celecoxib capsule is significantly slowed down during storage is solved by adding appropriate arginine in the prescription.

A novel compound complex that has no side effects on a liver and is used to alleviate the toxicity of an acetaminophen (APAP) drug to the liver. The composition of the compound consists of (a) acetaminophen in a pharmaceutically effective amount and (b) a commonly-used safe and pharmaceutically acceptable excipient that can be combined with one or more of two drugs to reduce the toxicity of a drug metabolized by the hepatic enzyme CYP2E1 in the liver.The compound is selected from the following group: Tween 20, microcrystalline cellulose, dicalcium phosphate, polyoxyethylene 23 lauryl ether, saccharin, mannitol, polyoxyethylene alkyl ether, sucralose, pyrrolidone, sodium starch glycolate, S100 acrylic resin, sodium carboxymethylcellulose, polyoxyethylene polyoxyethylene, menthol, low-substituted propylcellulose hydrocarbon, pregelatinized starch, Dextrates NF hydrate, citric acid, polyoxyethylene castor oil, colloidal silicon, aliphatic polyethylene glycol monostearate ester, sorbic acid, lemon oil, hydroxypropylcellulose, sorbitol, acesulfame potassium, hypromellose phthalate, lactose monohydrate, maltodextrin, Brij 58, Brij 76, Tween 80, Tween 40, PEG 400, Peg 4000, PEG 2000, and the like, so as to reduce the side effects caused by acetaminophen on the liver.

The invention discloses an erythromycin enteric-coated preparation and a preparation method thereof, and relates to the technical field of medicines. The erythromycin enteric-coated preparation comprises a plain pill and a water-soluble coating material, and the plain pill is prepared from the following raw materials in parts by weight: 125 parts of erythromycin, 35 parts of lactose monohydrate, 5 parts of povidone K90, 5 parts of monopotassium phosphate and 34-47.6 parts of purified water. According to the preparation method, K90 is taken as a raw material, after K90 is added, the erythromycin pellets have good forming degree during extrusion forming, the situation that the viscosity is too high does not exist, the obtained pellets are uniform in particle size and appropriate in size, and when the product is prepared, the sieving step can be omitted, the preparation steps can be reduced, and the production cost can be reduced.

The present invention relates to pharmaceutical dry powder formulations, comprising (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4′-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid of formula (I), preferably in form of one of its salts or solvates or hydrates, preferably (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4′-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid monohydrate (I) of formula (I-M-I) or (5S)-{[2-(4-carboxyphenyl)ethyl][2-(2-{[3-chloro-4′-(trifluoromethyl)biphenyl-4-yl]methoxy}phenyl)ethyl]-amino}-5,6,7,8-tetrahydroquinoline-2-carboxylic acid monohydrate (II) of formula (I-M-II) in combination with a lactose carrier, comprising lactose monohydrate as a mixture of coarse lactose and fine lactose, and to the process of manufacturing such pharmaceutical dry powder formulations and its application for use in the treatment of cardiopulmonary disorders, such as pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary hypertension (PH) associated with chronic lung disease (PH group 3) such as pulmonary hypertension in chronic obstructive pulmonary disease (PH-COPD) and pulmonary hypertension with idiopathic interstitial pneumonia (PH-IIP).

The invention provides a preparation method of a composite tablet. The preparation method comprises the following steps: S1, dissolving an adhesive and a wetting agent in water to form a solution; s2, putting the Aviavir, the lactose monohydrate, the filling agent and the disintegrating agent into a fluidized bed granulator, and introducing sterile hot air into the bottom of the fluidized bed granulator; spraying the solution of S1 into the top for wet granulation; s3, drying the wet particles in a fluidized bed to obtain dry particles; s4, uniformly mixing copibuxostat, colloidal silicon dioxide and a filling agent, crushing, sieving, and mixing with the crushed material in the step S3 and a lubricating agent to obtain a first material; s5, uniformly mixing emtricitabine, tenofovir propofol, the filler and the disintegrating agent, continuously and uniformly mixing with the lubricant, crushing and sieving; s6, mixing a disintegrating agent, a lubricating agent and the crushed material obtained in the step S52 to obtain a second material; and S7, performing double-layer tabletting on the first material and the second material. The composite tablet can improve the mixing uniformity of raw material medicines, and ensure the content uniformity and quality stability of medicines produced in different batches.

The invention discloses a fenerenone oral sustained-release dry suspension, which comprises particles, and a coating layer and a suspending aid layer which are sequentially coated on the surfaces of the particles, the granules are prepared from the following raw materials in parts by weight: 18 to 22 parts of fenerenone, 90 to 110 parts of microcrystalline cellulose, 76 to 80 parts of lactose monohydrate, 50 to 54 parts of hydroxypropyl methylcellulose, 8 to 10 parts of croscarmellose sodium and 0.8 to 1.2 parts of lauryl sodium sulfate. The invention also discloses a preparation method of the oral slow-release dry suspension of the fenerenone. According to the invention, auxiliary materials are matched with one another, so that the oral slow-release finerenone dry suspension has good slow-release performance and stability.

: The present invention relates to amorphous solid dispersions of Asundexian, and pharmaceutical compositions thereof. The present invention particularly relates to solid pharmaceutical dosage forms comprising amorphous solid dispersions of Asundexian and one or more pharmaceutically acceptable carrier selected from the group consisting of Gelucire, TPGS, PVAP Microcrystalline cellulose, Lactose monohydrate, Cross Carmellose sodium, Prosolv, Talc and mixture thereof.

This invention provides a quetiapine fumarate tablet composition and its preparation method. The composition contains the following components: quetiapine fumarate-hydroxypropyl-β-cyclodextrin co-treated product, povidone, calcium hydrogen phosphate, microcrystalline cellulose, sodium carboxymethyl starch, lactose monohydrate, magnesium stearate, and omeprazole. This invention also provides a method for processing a large-particle-size, highly fluid, highly soluble, and stable active pharmaceutical ingredient (API). This involves adding the API to a hydroxypropyl-β-cyclodextrin solution, homogenizing the resulting suspension, and spray-drying to prepare the quetiapine fumarate-hydroxypropyl-β-cyclodextrin co-treated product. The resulting intermediate powder obtained by wet granulation of the above-mentioned API-containing product exhibits superior flowability, smaller relative standard deviation of content uniformity, and a faster tableting rate after compression compared to tablets prepared solely from large-particle-size APIs, which is highly beneficial for industrial-scale production.

The present application discloses a brivaracetam rapid-release tablet and a preparation method thereof, belonging to the field of medical technology. The brivaracetam rapid-release tablets described in the present application include: 15-20wt% brivaracetam, 3-10wt% disintegrant, 60-70wt% diluent, 5-10wt% binder, 1-5wt% lubricant, using a polyvidone binder, can be granulated normally in the process of preparing the rapid-release tablet, without the problem of top-carriage, using sodium carboxymethyl starch and low-substituted hydroxypropyl cellulose as disintegrants, not only disintegrating quickly, but also brivaracetam can be dissolved in a short time, using lactose monohydrate and anhydrous lactose as diluents, solving the problem of astringency caused by lactose monohydrate, the prepared brivaracetam tablets dissolve quickly, and the process is simple, solving the problems of top-carriage and astringency in the preparation process, low production cost, suitable for large-scale production.

The invention relates to the technical field of pharmaceutical preparations, in particular to an indobufen-containing pharmaceutical composition and a preparation method thereof.The pharmaceutical composition is prepared from, by weight, 200 parts of indobufen, 175 parts of lactose monohydrate, 93 parts of microcrystalline cellulose, 41.6 parts of sodium carboxymethyl starch, 5.2 parts of lauryl sodium sulfate and 5.2 parts of magnesium stearate. According to the present invention, the purified water is adopted as the adhesive, and the particle size of the indobufen is controlled at D90: 10-20 [mu] m, such that the indobufen tablet has advantages of low production cost, good dissolution rate effect and suitableness for large-scale production.

The invention relates to the technical field of pharmaceutical preparations, in particular to kalii dehydrographolidi succinas lung inhalation dry powder as well as a preparation method and application thereof. The dry powder inhalation comprises an active component and an excipient, the active component is potassium dehydroandrographolide succinate, and the excipient comprises a filling agent, an atomization reinforcing agent and an antistatic agent; the filling agent comprises alpha-lactose monohydrate, trehalose, glucose, mannitol or xylitol; the atomization enhancer comprises leucine, alanine or glycine; the antistatic agent is poloxamer; the dry powder inhalation comprises the following components in percentage by mass volume w / v: 0.5%-1.4% of potassium dehydroandrographolide succinate, 0%-0.45% of alpha-lactose monohydrate, 0.45%-1.55% of leucine, 0.02%-0.4% of poloxamer 188 and 1%-5% of total solid content. The kalii dehydrographolidi succinas pulmonary inhalation dry powder inhalation with good dispersibility and in-vitro deposition performance is prepared; direct lung local drug delivery is achieved, the drug dosage is reduced, and the lung local drug concentration is increased.

This invention relates to a fixed-dose dry powder inhalation formulation comprising fluticasone propionate and albuterol sulfate, together with an α-lactose monohydrate carrier. In the formulation, the albuterol sulfate stabilises fluticasone propionate.

The present invention provides a pharmaceutical composition which is a tablet containing tafamidis free acid, one or more diluents, a disintegrant of 7 - 9% (w / w%) and a lubricant. A typical example is a tablet containing about 11.6% (w / w%) of tafamidis free acid; about 53.1% (w / w%) of microcrystalline cellulose; about 26.55% (w / w%) of lactose monohydrate; about 8.0% (w / w%) of crospovidone type b and about 0.75% (w / w%) of magnesium stearate. 【Figure 1】 TIFF2025524085000013.tif161105

The invention belongs to the field of medicaments, and provides candesartan cilexetil, 5-8 mg of hydrochlorothiazide, 7-10 mg of PEG (polyethylene glycol) 8000, 60-90 mg of lactose monohydrate, 3-8 mg of HPMC (hydroxypropyl methyl cellulose), 0.1-1 mg of magnesium stearate and 3-8 mg of disintegrating agent per 110 mg of the candesartan cilexetil, the hydrochlorothiazide, the PEG 8000, the lactose monohydrate, the HPMC, the magnesium stearate and the disintegrating agent. By selecting a proper disintegrating agent combination, the candesthia tablet disclosed by the invention effectively improves the dissolution performance in artificial gastric juice, and a basis is provided for further improvement of the drug effect.

The present disclosure provides oral dosage forms comprising about 8.75% w / w deuruxolitinib phosphate, about 50% to about 60% w / w microcrystalline cellulose, about 25% to about 35% w / w lactose monohydrate, about 3% to about 6% w / w polyvinylpyrrolidone, about 2% to about 4% w / w hydroxypropyl cellulose, about 0.25% to about 0.75% w / w colloidal silicon dioxide, and about 0.25% to about 0.75% w / w magnesium stearate.

The present invention provides a pharmaceutical composition, which is a tablet comprising free chlorbuconazole, one or more diluents, 7-9% (w / w%) disintegrant, and lubricant. A representative embodiment is comprising about 11.6% (w / w%) of free chloroazolate; about 53.1% (w / w%) microcrystalline cellulose; about 26.55% (w / w%) lactose monohydrate; tablets of about 8.0% (w / w%) type b cross-linked povidone and about 0.75% (w / w%) magnesium stearate.

The application belongs to the technical field of milk powder preparation, and particularly relates to a preparation process for improving lactose crystallinity in infant formula milk powder. The preparation process adds alpha-lactose monohydrate in the concentrated process before spray drying in the production of infant formula milk powder, and combines the optimization of the addition amount of alpha-lactose monohydrate, the concentration of concentrated milk and the temperature of concentrated milk to control the content of crystalline lactose in the concentrated milk solution, so as to accurately control the lactose crystallinity in the infant formula milk powder, and finally obtain high-quality infant formula milk powder with specific lactose crystallization characteristics, improve the storage stability of the product, break through the limitation that the traditional process cannot control the lactose crystallinity, fill the technical gap in the field, and provide a flexible and feasible technical scheme for improving the powder characteristics of infant formula milk powder.

The invention discloses a lamotrigine composition and a preparation process thereof. The lamotrigine composition is prepared from the following raw materials in mass concentration: 20-40% of lamotrigine, 30-40% of lactose monohydrate, 30-40% of microcrystalline cellulose, 1-4% of a disintegrating agent and 0.3-1% of magnesium stearate, and the total amount is 100%. The disintegrating agent is polyvinylpolypyrrolidone or sodium carboxymethyl starch. According to the lamotrigine composition provided by the invention, novel direct-mixing type auxiliary materials are adopted, the formula composition is simplified under the condition that the same in-vitro release target as a reference preparation is achieved, and the qualification of a product is further improved. According to the invention, a direct-mixing tabletting process is adopted, so that the production process is greatly simplified, and the production cost is reduced; water vapor and high temperature are avoided in the production process, and the stability of the product is ensured; the lamotrigine tablet prepared by the process has the advantages of uniform weight, complete appearance, no sticking and top cracking and the like, and is suitable for industrial production.

The present invention relates to a MT-1207 hydrochloride sustained-release preparation and a preparation method and application thereof. The MT-1207 hydrochloride sustained-release preparation comprises the following components in parts by weight: 20 parts of MT-1207 hydrochloride; 100-150 parts of D-lactose monohydrate; 15-25 parts of polyvinyl pyrrolidone; 30-80 parts of hydroxypropyl methylcellulose; 2-6 parts of silicon dioxide; 0.2-0.8 parts of magnesium stearate; the structural formula of the MT-1207 hydrochloride is shown in formula (I). The MT-1207 hydrochloride in the hydrochloride sustained-release preparation reaches a dissolution rate of more than 85% after dissolution for 24 hours, which can meet the requirements of sustained release. #imgabs0#

The invention discloses a hydrocortisone acetate tablet and a preparation process thereof, and the hydrocortisone acetate tablet comprises the following components in percentage by mass: 0.08-0.12% of hydrocortisone acetate, 0.05-0.12% of magnesium stearate, 0.05-0.12% of magnesium stearate, 0.05-0.12% of magnesium stearate, and the balance of magnesium stearate. 80 to 95% of lactose monohydrate; 2-8% of directly pressed corn starch; 0.2%-1.0% of a flow aid; the fluhydrocortisone acetate tablet is prepared by the following method: mixing the fluhydrocortisone acetate, the lactose monohydrate and the directly-pressed corn starch, and then sieving the mixture; and adding the flow aid and the lubricant, mixing, and tabletting. The simple and convenient direct pressing process is adopted, simplicity, convenience and stability are achieved, material and labor cost can be reduced, and large-scale production is facilitated. The pharmaceutical composition is simple in prescription, good in flowability and good in dissolution reproducibility, in-vivo bioavailability can be improved, and the pharmaceutical composition has the same or better safety and curative effect as those of an original pharmaceutical composition.

Disclosed is a nintedanib esylate inhalation powder composed of micronized nintedanib esylate and lactose monohydrate. Further disclosed are a preparation method for the nintedanib esylate inhalation powder and use thereof in the preparation of a drug for treating pulmonary diseases such as pulmonary diseases with fibrosis or lung cancer.

The invention belongs to the technical field of inhalation powder aerosols, and particularly discloses a preparation method of an inhalation particle composition with the bulk density of 0.26-0.28 g / ml. The composition comprises budesonide, formoterol fumarate dihydrate and lactose monohydrate, and the mass median diameter is 1t; the mass ratio of the raw materials is (80-160): 4.5: (3835.5-3915.5). The preparation method comprises the steps of high-shear mixing, high-humidity regulation, gravity compaction and two times of rolling agglomeration, and the bulk density is precisely regulated and controlled by controlling the compaction pressure (0.2-0.35 Mpa) and the agglomeration time (1-5 minutes). The problems that in the prior art, the degradation rate of active ingredients is high (impurities are larger than or equal to 1.2%), the process is complex (six steps), and the fluidity is poor (the repose angle is 45 degrees) are solved, the process steps are remarkably simplified, the impurities are reduced to be smaller than or equal to 0.5%, and the fluidity (the repose angle is smaller than or equal to 34 degrees) and the dose division precision (RSDlt; the device is suitable for a multi-dose reservoir type device such as Turbuhaler and the like, and is used for treating asthma and chronic obstructive pulmonary diseases.

The present application relates to the technical field of pharmaceutical preparation, and particularly discloses a felodipine enalapril tablet and a preparation method thereof. The felodipine enalapril tablet takes hydrochloric acid felodipine and maleic acid enalapril as active ingredients, and the auxiliary materials include lactose monohydrate, microcrystalline cellulose, crosslinked polyvinylpyrrolidone, sodium bicarbonate, povidone and magnesium stearate. The tablet is prepared through the processes of separate granulation, mixing, tabletting and coating. The felodipine enalapril tablet prepared by the present application has similar dissolution curve to the reference preparation, uniform content and good stability.