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US 2013/0259937 A1Published application
Amphipathic lipid-based sustained release compositions
AssigneePegasus Laboratories, Inc.
InventorsScott A. Howard, Troy Purvis
Life of this patent
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Abstract
Chewable sustained release compositions and their methods of production are provided. The sustained release compositions contain amphipathic lipids and matrix-forming polymers, which are used to encapsulate various drugs and active ingredients. The chewable sustained release compositions can maintain their sustained release properties even after being fragmented into a plurality of pieces.
Claims20
A composition comprising:
- (a) one or more active ingredients;
- (b) one or more amphipathic lipids;
- and
- (c) at least one bulking or spheronizing agent,
- wherein said active ingredients being encapsulated within a matrix comprising said amphipathic lipids,
- wherein said composition exhibits an in vitro dissolution rate of said active ingredients as measured by a USP Dissolution Apparatus II of about 10% to 50% after about 2 hours, about 25% to 90% after about 4 hours, more than about 60% after about 12 hours, and more than about 75% after about 16 hours,
- wherein the average in vitro dissolution rate of said composition as measured by a USP Dissolution Apparatus II does not increase by more than 100% during the first 2 hours after said composition has been fragmented into two or more pieces.
4 more elements
A composition comprising:
- (a) one or more active ingredients;
- (b) one or more amphipathic lipids;
- (c) at least one bulking or spheronizing agent;
- and
- (d) at least one plasticized matrix-forming polymer,
- wherein said at least one active ingredient being encapsulated within a matrix comprising said amphipathic lipids and said matrix-forming polymer,
- wherein said composition exhibits an in vitro dissolution rate of said active ingredients as measured by a USP Dissolution Apparatus II of about 10% to 50% after about 2 hours, about 25% to 90% after about 4 hours, more than about 60% after about 12 hours, and more than about 75% after about 16 hours.
4 more elements
A method for preparing tablets of a sustained release composition comprising:
- (a) combining one or more active ingredients, one or more amphipathic lipids, and at least one matrix-forming polymer in a solvent to produce an active-containing solution or suspension;
- (b) mixing said active-containing solution or suspension with at least one spheronizing or bulking agent to produce a mixture;
- and
- (c) forming said mixture into tablets,
- wherein said composition exhibits an in vitro dissolution rate of said active ingredients as measured by a USP Dissolution Apparatus II about 10% to 50% after about 2 hours, about 25% to 90% after about 4 hours, more than about 60% after about 12 hours, and more than about 75% after about 16 hours,
- wherein said steps (a)-(c) are performed at temperatures not exceeding the melting point of said amphipathic lipids,
- wherein said step (a) is performed at a temperature exceeding the glass transition temperature (“Tg”) of said matrix-forming polymer.
4 more elements
Dependencies are inferred from the claim text.