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BILAYERED PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION COMPRISING IMMEDIATE RELEASE LAYER COMPRISING ATORVASTATIN AND EXTENDED RELEASE LAYER COMPRISING METFORMIN

IP.com Disclosure Number: IPCOM000205309D
Publication Date: 2011-Mar-25
Document File: 6 page(s) / 81K

Publishing Venue

The IP.com Prior Art Database

Abstract

The present disclosure relates to a bilayered pharmaceutical composition for oral administration comprising an immediate release layer comprising atorvastatin or pharmaceutically acceptable salts thereof and an extended release layer comprising metformin or pharmaceutically acceptable salts thereof.

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This is the abbreviated version, containing approximately 25% of the total text.

BILAYERED PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION COMPRISING IMMEDIATE RELEASE LAYER COMPRISING ATORVASTATIN AND EXTENDED RELEASE LAYER COMPRISING METFORMIN

Abstract

The present disclosure relates to a bilayered pharmaceutical composition for oral administration comprising an immediate release layer comprising atorvastatin or pharmaceutically acceptable salts thereof and an extended release layer comprising metformin or pharmaceutically acceptable salts thereof.

We have developed a bilayered pharmaceutical composition for oral administration comprising an immediate release layer comprising atorvastatin or pharmaceutically acceptable salts thereof and an extended release layer comprising metformin or pharmaceutically acceptable salts thereof. The said comprises:

a)   An immediate release layer comprising atorvastatin or pharmaceutically acceptable salt thereof; and

b)   An extended release layer comprising metformin or pharmaceutically acceptable salt thereof.

In addition, the extended release later may comprise an extended release polymer.

Such composition can be made by a comprising the steps of:

a)      Blending atorvastatin or pharmaceutically acceptable salt thereof with pharmaceutically acceptable inert excipients;

b)      Optionally, granulating the blend of step(a);

c)      Lubricating the granules of step (b); or blend of step (a);

d)     Blending metformin or pharmaceutically acceptable salt thereof with other pharmaceutically acceptable inert excipients;

e)      Optionally, granulating the blend of step (d);

f)       Blending the blend of step (d); or granules obtained from step (e) with an extended release polymer(s); and

g)      Lubricating the blend obtained from step (f);

h)      Compressing the blend of step (c) and step (f) to obtain bilayered tablet dosage form.

Pharmaceutically acceptable salts of atorvastatin may include various salts such as calcium, magnesium, potassium, sodium, ammonium, aluminum, iron, and zinc. Pharmaceutically acceptable salts of metformin may include phosphate, sulfate, hydrochloride, salicylate, maleate, benzoate, ethanedisulfonate, fumarate and glycolate. Atorvastatin or its pharmaceutically acceptable salts and metformin or pharmaceutically acceptable salts may exist in any polymorphic form such as crystalline or amorphous.

The term “extended release”, as used herein, means that the therapeutically active medicament or drug is released from the pharmaceutical composition over a prolonged period of time in such a manner as to provide substantial plasma level of the drug following once-a-day dosing. The term “immediate release”, as used herein, means that at least 80% of the therapeutically active medicament or drug in the pharmaceutical composition is dissolved within 30 minutes under a dissolution test using USP apparatus. Pharmaceutical composition may be in the form of a tablet or a caplet. The term “bilayered tablet dosage form”, as used herein, means a compressed dosage form having two distinct layers. The...