Invention Grant
- Patent Title: Extended release pharmaceutical formulations of water-soluble active pharmaceutical ingredients and methods for making the same
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Application No.: US14381944Application Date: 2013-02-28
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Publication No.: US10973768B2Publication Date: 2021-04-13
- Inventor: Deniz Erdemir , Shih-Ying Chang , Divyakant Desai , San Kiang
- Applicant: Bristol-Myers Squibb Company
- Applicant Address: US NJ Princeton
- Assignee: Bristol-Myers Squibb Company
- Current Assignee: Bristol-Myers Squibb Company
- Current Assignee Address: US NJ Princeton
- Agency: Mcdonnell Roohnpn Hulbert & Bergholf LLP
- International Application: PCT/US2013/028289 WO 20130228
- International Announcement: WO2013/130785 WO 20130906
- Main IPC: A61K9/48
- IPC: A61K9/48 ; A61K9/28 ; A61K9/16 ; A61K9/14 ; A61K31/155 ; A61K9/24 ; A61J3/10 ; A61K9/20 ; A61K31/7004 ; A61K31/403

Abstract:
The present disclosure relates to methods for making extended-release formulations of water-soluble active pharmaceutical ingredients such as metformin HCl. In one aspect, the disclosure provides a method that includes adding an aqueous solution of an active pharmaceutical ingredient to an agitated mixture of one or more release-modifying polymers and optionally one or more binders in one or more organic solvents, the one or more organic solvents together being an antisolvent for the active pharmaceutical ingredient, water being sufficiently soluble in the one or more organic solvents such that the water added as part of the aqueous solution dissolves in the mixture, the addition thereby precipitating the active pharmaceutical ingredient; separating the active pharmaceutical ingredient and the one or more release-modifying polymers and, if present, the one or more binders from the one or more organic solvents to yield co-processed particles; and drying the co-processed particles. The methods can be used to make dosage forms such as tablets having reduced amounts of release-modifying polymers.
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