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Claims for Patent: 5,916,595

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Claims 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.
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