Medicament carriers in the form of film having active substance incorporated therein

• US 4,136,145 A
• Filed: 07/20/1976
• Issued: 01/23/1979
• Est. Priority Date: 07/05/1974
• Status: Expired due to Term

• Current Assignee: Schering Ag (Merck & Co., Inc.)
• Original Assignee: Schering Ag (Merck & Co., Inc.)
• Inventors: Fuchs, Peter, Hilmann, Jurgen
• Primary Examiner(s): Woo, Jay H.
• Application Number:
  US05/707,032
• Time in Patent Office: 917 Days
• Field of Search: 264/185, 264/186, 264/171, 264/205, 264/210 R, 264/184, 264/164, 264/165, 264/308, 264/299, 264/298, 106/162, 106/209, 106/205, 106/210, 424/22, 424/32, 424/33
• US Class Current: 264/164
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence

Abstract

Pharmaceutical composition unit dosage forms adapted for enteral or topical administration are described, comprising a safe and effective amount of a pharmaceutically active medicament compound dissolved or uniformly dispersed in a flexible, water-soluble film carrier therefor. Admixtures of medicament and carrier are drawn into a film, which can be cut to desired unit dosage content.

Claims

1. A process for the preparation of a pharmaceutical composition in unit dosage form adapted for enteral or topical administration and comprising a safe and effective amount of a pharmaceutically active medicament compound uniformly dispersed throughout a flexible, water-soluble film carrier therefor, which comprises the steps of:

(a) drawing into a sheet having a uniform layer thickness of about 0.1-2 mm and a dry thickness of about 0.05-1 mm., a homogeneous solution or suspension consisting essentially of (1) up to 60% by weight, based on the film carrier, of the medicament, (2) 0-30% by weight of a pharmaceutically acceptable filler, (3) a film-forming amount of a water-soluble film-forming polymer, and (4) as solvent or suspending medium, one or both of water and an organic volatile solvent system comprising an organic polar solvent miscible in water; and

(b) drying the thus-formed sheet to remove the solvent or suspending medium therefrom.

2. A process according to claim 1 wherein the solution or suspension contains about 6-20% by weight of the film-forming polymer, about 48-84% by weight of the solvent or suspension medium and about 0.01-2% by weight of a pharmaceutically acceptable release agent.

3. A process according to claim 2 wherein the solvent or suspension medium is an aqueous system.

4. A process according to claim 3 wherein the aqueous system is aqueous ethanol.

5. A process according to claim 2 wherein the solvent or suspension medium is an organic volatile solvent system.

6. A process according to claim 5 wherein the organic volatile solvent system is a mixture of methylene chloride and ethyl alcohol.

7. A process according to claim 1 wherein the film-forming polymer is a non-ionic, water-soluble hydroxyalkyl ether of cellulose.

8. A process according to claim 1 wherein the solution or suspension comprises an insoluble filler and the drawn and dried sheet is paper-like.

9. A process according to claim 2 wherein the filler is cellulose.

10. A process according to claim 1 wherein the solution is free of filler and the drawn and dried sheet is a transparent film.

11. A process according to claim 1 wherein a plurality of solutions or suspensions of differing pharmaceutically active medicament composition are drawn side-by-side into a coherent sheet having a plurality of parallel strips across its width.

12. A process according to claim 11 wherein the plurality of solutions or suspensions contain identifying dyestuffs of different colors.