Controlled release formulation for water insoluble drugs in which a passageway is formed in situ

• US 5,736,159 A
• Filed: 04/28/1995
• Issued: 04/07/1998
• Est. Priority Date: 04/28/1995
• Status: Expired due to Term

• Current Assignee: Andrx Pharmaceuticals LLC (Abbvie Incorporated)
• Original Assignee: Andrx Pharmaceuticals (NC), Inc. (Abbvie Incorporated)
• Inventors: Chen, Chih-Ming, Xie, Jianbo, Lee, Der-Yang
• Primary Examiner(s): Hulina, Amy
• Application Number:
  US08/430,356
• Time in Patent Office: 1,075 Days
• Field of Search: 424/474, 424/480, 424/472, 424/473
• US Class Current: 424/480
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/282 Organic compounds, e.g. fats
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

A controlled release pharmaceutical tablet is disclosed which is based on:

(a) a compressed core which contains:

(i) a medicament;

(ii) at least 23% to 55% by weight, based on the total weight of the core, of a water soluble osmotic agent;

(iii) a water soluble pharmaceutically acceptable polymeric binder;

(iv) a water-swellable pharmaceutically acceptable polymer;

(v) a conventional pharmaceutical excipient; and

(b) a membrane coating around said core tablet which consists essentially of:

(i) a modified water insoluble pharmaceutically acceptable polymer; and

(ii) a pharmaceutically acceptable water soluble polymer.

Claims

1. A controlled release pharmaceutical tablet which comprises:

a) a compressed core which consists essentially of;

(i) a calcium channel blocker;

(ii) at least 23% to 55% by weight, based on the total weight of the core, of a water soluble osmotic agent;

(iii) a water soluble pharmaceutically acceptable polymeric binder;

(iv) a water-swellable pharmaceutically acceptable polymer; and

(b) a membrane coating around said core tablet which consists essentially of triacetin plasticized cellulose acetate, hydroxypropyl cellulose and polyethylene glycol.

3. A controlled release pharmaceutical tablet as defined in claim 1 wherein the calcium channel blocker is nifedipine in crystalline form and the water swellable polymer is a poly(ethylene oxide).

4. A controlled release pharmaceutical tablet as defined in claim 1 wherein the calcium channel blocker is nifedipine in amorphous form and the water swellable polymer is a poly(ethylene oxide).

5. A controlled release pharmaceutical tablet as defined in claim 1 wherein the calcium channel blocker is nifedipine as a blend of the crystalline and amorphous forms and the water swellable polymer is a poly(ethylene oxide).

2. A controlled release pharmaceutical tablet which comprises:

a) a compressed core which consists essentially of;

(i) a calcium channel blocker;

(ii) at least 23% to 55% by weight, based on the total weight of the core, of a water soluble osmotic agent;

(iii) a water soluble pharmaceutically acceptable polymeric binder;

(iv) a water-swellable pharmaceutically acceptable polymer; and

(b) a membrane coating around said core tablet which consists essentially of triacetin plasticized sucrose and hydroxypropyl cellulose.

6. A controlled release pharmaceutical tablet which comprises:

a) a compressed core which consists essentially of;

(i) a calcium channel blocker;

(ii) at least 23% to 55% by weight, based on the total weight of the core, of a water soluble osmotic agent;

(iii) a water soluble pharmaceutically acceptable polymeric binder;

(iv) a water-swellable pharmaceutically acceptable polymer;

(v) microcrystalline cellulose and polysorbate 80; and

(b) a membrane coating around said core tablet which consists essentially of triacetin plasticized cellulose acetate, hydroxypropyl cellulose and polyethylene glycol.