Preparation of gelatin-encapsulated controlled release composition

• US 4,708,834 A
• Filed: 05/01/1986
• Issued: 11/24/1987
• Est. Priority Date: 05/01/1986
• Status: Expired due to Term

• Current Assignee: Banner Pharmacaps Incorporated (Thermo Fisher Scientific Incorporated)
• Original Assignee: Pharmacaps Incorporated
• Inventors: Cohen, Jonathan M., Berry, Ira R., Borkan, Lionel
• Primary Examiner(s): Lovering, Richard D.
• Application Number:
  US06/858,969
• Time in Patent Office: 572 Days
• Field of Search: 264/4.3, 428/402.2, 424/22, 424/35, 424/37, 424/456, 424/460, 424/461, 514/944
• US Class Current: 264/4.3
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: Y10T 428/2984 Microcapsule with fluid core [includes liposome]
• CPC Class Codes: Y10T 428/2989 Microcapsule with solid core [includes liposome]

Abstract

A controlled-release pharmaceutical unit dosage form is provided comprising a gelatin capsule enclosing a solid matrix formed by the cation-assisted gellation of a liquid fill incorporating a vegetable gum and a pharmaceutically-active compound, as well as methods for the preparation thereof.

Claims

1. A method for preparing a controlled-release pharmaceutical unit dosage form comprising:

(a) forming a liquid fill comprising an aqueous solution or dispersion of a polysaccharide gum and a pharmaceutically-active compound;

(b) encapsulating said liquid fill in a gelatin capsule; and

(c) gelling said liquid fill with an effective amount of a cationic gelling agent comprising metal cations or ammonium ions to form a polymeric matrix having said active compound uniformly dispersed throughout.

2. The method of claim 1 wherein the liquid fill is encapsulated in a plasticized gelatin capsule.

3. The method of claim 1 wherein the polysaccharide gum is selected from the group consisting of alginate, kappa-carrageenan, pectin and mixtures thereof.

4. The method of claim 1 wherein the metal cations or the ammonium ions are incorporated in the gelatin capsule.

5. The method of claim 4 wherein the metal cation comprises calcium chloride, potassium chloride or mixtures thereof.