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US 2012/0231081 A1Published application
Controlled release dosage forms
AssigneeValeant International (Barbados) SRL
InventorSteven FRISBEE
Life of this patent
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Abstract
The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.
Claims17
A controlled release oral dosage form comprising:
- a. an immediate release core, comprising about 1000 mg of metformin hydrochloride;
- and
- b. a controlled release coating surrounding said core,
- wherein said dosage form provides an in-vitro release rate of the metformin hydrochloride when tested by the USP Apparatus II (Paddle Apparatus) method at 50 rpm, in 900 mL water and at about 37° C., such that nor more than about 29% of the metformin hydrochloride is released after about 1 hour and not more than about 41% of the metformin hydrochloride is released after about 3 hours.
1 more element
A controlled release oral dosage form comprising:
- a. an immediate release core, comprising about 1000 mg of metformin hydrochloride;
- and
- b. a controlled release coating surrounding said core,
- wherein said dosage form provides an in-vitro release rate of the metformin hydrochloride when tested by the USP Apparatus I (Basket Apparatus) method at 100 rpm, in 900 mL simulated gastric fluid USP and at about 37° C., such that between about 18% and about 29% of the metformin hydrochloride is released after about 2 hours, between about 34% and about 50% of the metformin hydrochloride is released after about 4 hours, and between about 67% and about 78% of the metformin hydrochloride is released after about 8 hours.
1 more element
A controlled release oral dosage form comprising:
- a. an immediate release core, comprising about 1000 mg of metformin hydrochloride;
- and
- b. a controlled release coating surrounding said core,
- wherein said dosage form provides an in-vitro release rate of the metformin hydrochloride when tested by the USP Apparatus I (Basket Apparatus) method at 100 rpm, in 900 mL simulated gastric fluid USP and at about 37° C., such that not more than about 30% of the metformin hydrochloride is released after about 2 hours and not more than about 50% of the metformin hydrochloride is released after about 4 hours.
1 more element
Dependencies are inferred from the claim text.