Once daily pharmaceutical tablet having a unitary core

• US 5,837,379 A
• Filed: 01/31/1997
• Issued: 11/17/1998
• Est. Priority Date: 01/31/1997
• Status: Expired due to Term

• Current Assignee: Allergan Sales LLC (Abbvie Incorporated)
• Original Assignee: Andrx Pharmaceuticals (NC), Inc. (Abbvie Incorporated)
• Inventors: Chou, Joseph C. H., Chen, Chih-Ming
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Benston, Jr., William E.
• Application Number:
  US08/791,999
• Time in Patent Office: 655 Days
• Field of Search: 424/465, 424/490, 424/489, 424/467, 424/469, 424/473
• US Class Current: 424/465
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas

Abstract

A controlled release nifedipine tablet which comprises:

(a) a homogeneous compressed core which comprises:

(i) a medicament;

(ii) a water soluble osmotic compound

(iii) one or more osmotic polymers; and

(b) a membrane coating which completely covers said core tablet which comprises a mixture of:

(i) a water insoluble pharmaceutically acceptable polymer; and

(ii) an enteric polymer.

Claims

1. A once a day controlled release tablet which comprises:

(a) a homogeneous compressed core of granules produced in a fluidized bed, said core said core comprising;

(i) a medicament;

(ii) a water soluble osmotic compound;

(iii) one or more osmotic polymers wherein one of the osmotic polymers is a water swellable osmotic polymer; and

(b) a membrane coating which completely covers said core tablet which comprises a mixture of;

(i) a water insoluble pharmaceutically acceptable polymer; and

(ii) an enteric polymer.

2. A controlled release pharmaceutical tablet as defined in claim 1 wherein the medicament is a calcium channel blocker compound.

3. A controlled release pharmaceutical tablet as defined in claim 2 wherein the medicament is nifedipine.

4. A controlled release pharmaceutical tablet as defined in claim 1 which includes two osmotic polymers.

5. A controlled release pharmaceutical tablet as defined in claim 1 wherein the water swellable polymer is selected from the group consisting of poly(ethylene oxide), hydroxypropylmethylcellulose and mixtures thereof.

6. A controlled release pharmaceutical tablet as defined in claim 1 wherein the membrane around the core contains an enteric polymer which is a methacrylic acid/methyl methacrylate polymer.

7. A controlled release pharmaceutical tablet as defined in claim 1 wherein the water insoluble polymer in the membrane around the core is a water insoluble cellulose derivative.

8. A controlled release pharmaceutical tablet as defined in claim 7 wherein the water insoluble cellulose derivative in the membrane around the core is cellulose acetate.

9. A controlled release pharmaceutical tablet as defined in claim 1 wherein the mixture of the water insoluble polymer and the enteric polymer contain a plasticizer.

10. A controlled release pharmaceutical tablet as defined in claim 9 wherein the plasticizer is triacetin.

11. A controlled release pharmaceutical tablet as defined in claim 9 wherein the mixture of the water insoluble polymer and the enteric polymer contain a water soluble channeling agent.

12. A controlled release pharmaceutical tablet as defined in claim 9 wherein the mixture of the water insoluble polymer and the enteric polymer is overcoated with an additional layer of an enteric polymer.

13. A controlled release pharmaceutical tablet as defined in claim 12 wherein the enteric polymer overcoat is hydroxypropyl methylcellulose phthalate which is plasticized with acetyltributyl citrate.

14. A once a day controlled release nifedipine tablet which comprises:

(a) a homogeneous compressed core made from granules produced in a fluidized bed process said core consisting essentially of;

(i) nifedipine;

(ii) a water soluble osmotic compound;

(iii) polyethylene oxide; and

(b) a membrane coating which completely covers said core tablet which comprises a mixture of;

(i) a water insoluble pharmaceutically acceptable polymer; and

(ii) an enteric polymer.

15. A once a day controlled release tablet which comprises:

(a) a homogeneous compressed core of granules produced in a fluidized bed, said core said core consisting essentially of;

(i) a medicament;

(ii) a water soluble osmotic compound;

(iii) one or more osmotic polymers wherein one of the osmotic polymers is a water swellable osmotic polymer; and

(b) a membrane coating which completely covers said core tablet which comprises a mixture of;

(i) a water insoluble pharmaceutically acceptable polymer; and

(ii) an enteric polymer.