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Claims for Patent: 7,780,987

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Claims for Patent: 7,780,987

Title:Controlled release dosage forms
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.degree. C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.
Inventor(s): Zhou; Fang (Centreville, VA), Maes; Paul (Potomac, MD)
Assignee: Biovail Laboratories International SRL (St. Michael, BB)
Application Number:10/370,109
Patent Claims: 1. A pharmaceutical oral dosage form comprising an oral dosage form coated with a stable controlled release monolithic coating, wherein the stable controlled release monolithic coating is applied onto the oral dosage form by a process comprising coating the oral dosage form with a coating composition to form a coated oral dosage form, and curing the coated oral dosage form at a temperature of at least 55.degree. C. to form the stable controlled release monolithic coating, wherein the coating composition consists essentially of a neutral ester copolymer in an amount of from about 1% to about 35% by weight of the coating composition based on ethyl acrylate and methyl acrylate selected from the group consisting of a 30% aqueous dispersion of a neutral ester copolymer based on ethyl acrylate and methyl methacrylate, a 40% aqueous dispersion of a neutral ester copolymer based on ethyl acryl ate and methyl methacrylate, and combinations thereof; a polyethylene glycol selected from the group consisting of polyethylene glycol 6000, polyethylene glycol 8000, polyethylene glycol 10000, polyethylene glycol 20000, and combinations thereof in an amount of from about 0.1% to about 3% by weight of the coating composition; and one or more of a hydrophilic agent, and a pharmaceutically acceptable excipient.

2. The pharmaceutical dosage form of claim 1, wherein said pharmaceutical dosage form is selected from the group consisting of a tablet and a capsule.

3. The pharmaceutical oral dosage form of claim 1, wherein the oral dosage form comprises metformin, a pharmaceutically acceptable salt thereof, or a combination thereof.

4. A method of manufacturing a pharmaceutical oral dosage form coated with a stable controlled release monolithic coating, the method comprising coating the oral dosage form with a coating composition to form a coated oral dosage form, and curing the coated oral dosage form at a temperature of at least 55.degree. C. to form the stable controlled release monolithic coating, wherein the coating composition consists essentially of a neutral ester copolymer based on ethyl acrylate and methyl acrylate selected from the group consisting of a 30% aqueous dispersion of a neutral ester copolymer based on ethyl acrylate and methyl methacrylate, a 40% aqueous dispersion of a neutral ester copolymer based on ethyl acrylate and methyl methacrylate, and combinations thereof in an amount of from about 1% to about 35% by weight of the coating composition; a polyethylene glycol selected from the group consisting of polyethylene glycol 6000, polyethylene glycol 8000, polyethylene glycol 10000, polyethylene glycol 20000, and combinations thereof in an amount of from about 0.1% to about 3% by weight of the coating composition; and one or more of a hydrophilic agent, and a pharmaceutically acceptable excipient.

5. The method of claim 4, wherein said pharmaceutical dosage form is selected from the group consisting of a tablet and a capsule.

6. The method of claim 4, wherein the oral dosage form comprises metformin, a pharmaceutically acceptable salt thereof, or a combination thereof.
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