Controlled release pharmaceutical compositions of galantamine

The controlled release pharmaceutical compositions of Galantamine using matrix mini tablets with water-soluble or insoluble materials address the complexity and cost issues of existing formulations, offering a cost-effective, stable, and bioequivalent once-a-day administration with reduced side effects and improved patient compliance.

WO2011064797A2 Publication Date: 2011-06-03USV LTD +3
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Patent Information

Application Number
PCT/IN2010/000767
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2009-11-26
Filing Date
2010-11-26
Publication Date
2011-06-03

AI Technical Summary

Technical Problem

Existing controlled release formulations of Galantamine are costly and complex, with multiple step processes that increase production costs and render the product expensive, while also leading to side effects associated with immediate release dosage forms.

Method used

Development of controlled release pharmaceutical compositions comprising matrix mini tablets with Galantamine hydrobromide and pharmaceutically acceptable additives, which can be filled into empty capsule shells, utilizing water-soluble, insoluble, or swellable materials as release modifying agents without a rate controlling coating, to achieve a controlled release profile.

Benefits of technology

The solution provides a cost-effective, easy-to-prepare controlled release form with improved patient compliance, reduced side effects, and a reliable release rate for Galantamine, allowing once-a-day administration with a desired drug release profile similar to marketed products like Reminyl XL®, while maintaining stability and bioequivalence.

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Abstract

Disclosed are controlled release pharmaceutical compositions of Galantamine comprising a plurality of matrix mini tablets comprising Galantamine or its pharmaceutically acceptable salt and at least one release modifying agent. Said compositions are characterized by the absence of release rate modifying coating and / or absence of an immediate release portion of the Galantamine.
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