19 results about "LACTOSE MONOHYDRATE" patented technology

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 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 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).

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.

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 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 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 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.

The invention relates to a preparation method of fosaprepitant dimeglumine for injection. The preparation method comprises the following steps: preparing a first solution from a first part of lactose monohydrate and a part of fosaprepitant dimeglumine; preparing a second part of lactose monohydrate, polysorbate-80 and edetate disodium into a solution, and adding other parts of fosaprepitant dimeglumine to obtain a second solution; mixing the first solution with the second solution to obtain a liquid medicine; and then freeze-drying the liquid medicine to obtain the fosaprepitant dimeglumine for injection. The invention also relates to fosaprepitant dimeglumine for injection, which is prepared by the preparation method. According to the invention, the lactose monohydrate is used as the excipient, and the stability problem caused by the lactose monohydrate as the excipient is solved by adjusting the preparation process of the liquid medicine and the pH value of the liquid medicine.

The invention belongs to the field of medicaments, and provides a perindopril amlodipine tablet and a preparation method thereof, and the perindopril amlodipine tablet comprises perindopril arginine, amlodipine besylate, lactose monohydrate, microcrystalline cellulose and a lubricant. According to the perindopril amlodipine tablet disclosed by the invention, good uniformity, stability and dissolution performance are realized by adjusting the lubricant and the formula.

The invention discloses a composition and a preparation method of a masutentan tablet, the formula comprises masutentan, lactose (monohydrate), microcrystalline cellulose, povidone K30, croscarmellose sodium, magnesium stearate, polysorbate 80, L-cysteine and purified water, and the use amount of L-cysteine is 0.1%-0.9% of the use amount of the main drug masutentan. The masutentan tablet disclosed by the invention is simple in composition, stable in quality and simple and convenient in preparation process, and L-cysteine is adopted as an antioxidant, so that the oxidative degradation of the masutentan can be inhibited under a strong oxygen condition, the level of impurities generated after the masutentan is degraded is lower, the toxic and side effects of the medicine are further reduced, and the medication safety is improved.

Methods and apparatus for using Raman spectroscopy to identify and quantify lactose isomers in solid samples. In one example, a method is performed via a computing device for providing support to a Raman instrument and includes receiving from the Raman instrument a set of electrical readout signals representing a low-frequency Raman (LFR) spectrum of a solid sample including lactose. The method further includes the computing device estimating percentages of α-lactose monohydrate and anhydrous β-lactose in the total amount of lactose present in the solid sample using a selected multivariate chemometric model and further using the LFR spectrum.