Once daily calcium channel blocker tablet having a delayed release core

• US 5,922,352 A
• Filed: 01/31/1997
• Issued: 07/13/1999
• Est. Priority Date: 01/31/1997
• Status: Expired due to Term

• Current Assignee: Andrx Pharmaceuticals LLC (Teva Pharmaceutical Industries Limited)
• 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:
  US08/792,001
• Time in Patent Office: 893 Days
• Field of Search: 424/465, 424/489, 424/476
• US Class Current: 424/465
• CPC Class Codes: A61K 9/2077 Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer

Abstract

A controlled release dosage form which comprises:

(a) a homogeneous compressed core which comprises a compressed granulation of:

(i) particles of a calcium channel blocker compound coated with an enteric polymer that are dispersed onto a solid pharmaceutical filler; and

(b) a continuous compressed outer layer around said homogeneous compressed core which comprises a compressed granulation of:

(i) one or more pharmaceutically acceptable polymers which form a hydrogel in which calcium channel blocker compound is dispersed.

Claims

1. A controlled release dosage form which comprises:

(a) a delayed release homogeneous compressed core which comprises a compressed granulation of;

(i) particles of a calcium channel blocker compound coated with an enteric polymer that are dispersed onto a solid pharmaceutical filler; and

(b) a continuous compressed outer layer around said homogeneous compressed core which comprises a compressed granulation of;

(i) one or more pharmaceutically acceptable polymers which form a hydrogel in which calcium channel blocker compound is dispersed.

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

3. A controlled release pharmaceutical tablet as defined in claim 2 wherein the enteric polymer is selected from the group consisting of hydroxypropylmethylcellulose phthalate, cellulose acetate phthalate, shellac and polymethyl methacrylate copolymers.

4. A controlled release pharmaceutical tablet as defined in claim 3 wherein the enteric coating is plasticized with a plasticizer.

5. A controlled release pharmaceutical tablet as defined in claim 4 wherein the enteric coating is plasticized with triacetin.

6. A controlled release pharmaceutical tablet as defined in claim 1 wherein the pharmaceutically acceptable polymer which forms a hydrogel is hydroxypropyl cellulose.

7. A controlled release pharmaceutical tablet which consists essentially of

(a) a delayed release homogeneous compressed core which consists essentially of a compressed granulation of:

(i) particles of nifedipine coated with hydroxypropylmethyl cellulose phthalate which is dispersed on an anhydrous lactose; and

(b) a continuous extended release compressed outer core layer around said homogeneous compressed core which consists essentially of a compressed granulation of;

(i) hydroxypropyl cellulose;

(ii) nifedipine; and

(iii) anhydrous lactose.

8. A controlled release pharmaceutical tablet as defined in claim 7 wherein the core contains a tablet lubricant.

9. A controlled release dosage form which consists essentially of:

(a) a delayed release homogeneous compressed core which consists essentially of a compressed granulation of;

(i) particles of a calcium channel blocker compound coated with an enteric polymer that are dispersed onto a solid pharmaceutical filler; and

(b) a continuous compressed outer layer around said homogeneous compressed core which consists essentially of a compressed granulation of;

(i) one or more pharmaceutically acceptable polymers which form a hydrogel in which calcium channel blocker compound is dispersed.