Claims for Patent: 5,916,595

Summary for Patent: 5,916,595

Title:	HMG co-reductase inhibitor
Abstract:	A controlled release dosage formulation is described which is based on a combination of: (a) a compressed tablet core which contains an alkyl ester of a hydroxy substituted naphthalene derivative a pharmaceutically acceptable, water swellable polymer and an osmotic agent; and (b) an outer coating layer which completely covers the osmotic core and comprises a pH sensitive coating agent and a water insoluble polymer.
Inventor(s):	Chen; Chih-Ming (Davie, FL), Chou; Joseph (Coral Springs, FL), Wong; David (Hollywood, FL)
Assignee:	Andrx Pharmaceutials, Inc. (Fort Lauderdale, FL)
Application Number:	08/989,253
Patent Claims:	1. A controlled release formulation containing an alkyl ester of a hydroxy substituted naphthalene compound, said formulation comprising: (a) a compressed tablet core which contains an alkyl ester of a hydroxy substituted naphthalene compound, a pharmaceutically acceptable, water swellable polymer and an osmotic agent; and (b) an outer coating layer which completely covers the osmotic core and comprises a pH sensitive coating agent, a channeling agent and a water insoluble cellulosic polymer used at a weight ratio of 0.1:1 to 0.75:1 and at a combined coating weight of 0.5-5% by weight. 2. A controlled release formulation as defined in claim 1 wherein the alkyl ester of a hydroxy substituted naphthalene compound is selected from the group consisting of mevastatin, pravastatin, simvastatin and lovastatin. 3. A controlled release dosage form as defined in claim 2 wherein said compressed tablet core is provided with a first coating to seal the tablet core. 4. A controlled release dosage form as defined in claim 2 wherein said compressed tablet core is provided with an inner enteric coating. 5. A controlled release dosage form as defined in claim 2 wherein said compressed tablet core is provided with an overcoat which is an enteric coating. 6. A controlled release dosage form as defined in claim 2 wherein the pharmaceutically acceptable water swellable polymer is polyethylene oxide. 7. A controlled release dosage form as defined in claim 2 wherein the osmotic agent is anhydrous lactose. 8. A controlled release dosage form as defined in claim 2 wherein the pH sensitive coating agent is a copolymer of poly(methacrylic acid and methylmethacrylate. 9. A controlled release dosage form as defined in claim 2 wherein the tablet core contains a surface active agent. 10. A controlled release dosage form as defined in claim 2 wherein the tablet core contains sodium lauryl sulfate. 11. A controlled release dosage form which comprises: (a) a compressed tablet core which comprises lovastatin, a polyoxyethylene water swellable polymer and anhydrous lactose; (b) an outer coating layer which comprises a mixture of a copolymer of poly(methacrylic acid/methylmethacrylate and a cellulose acetate polymer at a weight ratio of 0.1:1 to 0.75:1. 12. A controlled release dosage formulation which comprises: (a) a compressed tablet core comprising lovastatin, a pharmaceutically acceptable, water swellable polymer and an osmotic agent; (b) an inner coating layer which comprises a pH sensitive coating agent; and (c) an outer coating layer which comprises a pH sensitive coating agent, a channeling agent and a water insoluble cellulosic polymer.