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ORALLY DISPERSIBLE PHARMACEUTICAL COMPOSITION OF ATORVASTATIN

IP.com Disclosure Number: IPCOM000240693D
Publication Date: 2015-Feb-18
Document File: 10 page(s) / 57K

Publishing Venue

The IP.com Prior Art Database

Abstract

The present disclosure relates to an orally dispersible pharmaceutical composition comprising atorvastatin and one or more pharmaceutically acceptable excipients, and processes for the preparation of said composition.

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ORALLY DISPERSIBLE PHARMACEUTICAL COMPOSITION OF ATORVASTATIN

Abstract

The present disclosure relates to an orally dispersible pharmaceutical composition comprising atorvastatin and one or more pharmaceutically acceptable excipients, and processes for the preparation of said composition. 

Reported herein is an orally dispersible pharmaceutical composition comprising atorvastatin and one or more pharmaceutically acceptable excipients, wherein said pharmaceutical composition disintegrates within 60 seconds in water at 37°C.

The term “orally dispersible,” as used herein, refers to the composition which, when placed in water at 37°C, disperses within 60 seconds, preferably within 30 seconds.

The term “pharmaceutical composition,” as used herein, refers to tablets, pills, granules, or capsules.  In particular, the pharmaceutical composition of the present disclosure is a tablet.

The term “atorvastatin,” as used herein, refers to all polymorphic forms such as crystalline or amorphous.  It further includes atorvastatin’s pharmaceutically acceptable salts, hydrates, or solvates.  The term “pharmaceutically acceptable salts,” as used herein, includes calcium, magnesium, or potassium.

Reported herein is an orally dispersible pharmaceutical composition comprising atorvastatin and one or more pharmaceutically acceptable excipients, wherein said pharmaceutical composition releases at least 80% of atorvastatin in 15 minutes, when measured in a USP type II dissolution apparatus, paddle rotating at 75 RPM, at a temperature of 37°C ±0.5°C, in 900 mL of pH 6.8.

The desired in-vitro release profile of the present disclosure is similar to the marketed composition of atorvastatin (Lipitor®).

The term “pharmaceutically acceptable excipients,” as used herein, includes disintegrating agents, diluents, sweetening agents, effervescent agents, lubricants, binders, alkaline stabilizers, coloring agents, flavoring agents, taste-masking agents, surfactants, and mixtures thereof.

Suitable disintegrating agents used herein are selected from the group comprising sodium starch glycolate, cross-linked polyvinylpyrrolidone, croscarmellose, calcium carboxymethyl cellulose, pregelatinized starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and mixtures thereof.  The amount of disintegrating agents ranges from about 3% w/w to about 30% w/w of the composition.

Suitable diluents used herein are selected from the group comprising lactose, starch, mannitol, sucrose, sorbitol, xylitol, lactitol, erythritol, maltitol, hydroxylpropyl cellulose, pregelatinized starch, microcrystalline cellulose, calcium carbonate, dicalcium phosphate, and mixtures thereof.  The amount of diluents ranges from about 5% w/w to about 80% w/w of the composition.  In particular, the diluent used in the orally dispersible pharmaceutical composition of the present disclosure is mannitol.

Suitable sweetening agents used herein are selected from the group...