Controlled release bases for pharmaceuticals

• US 4,970,075 A
• Filed: 04/05/1989
• Issued: 11/13/1990
• Est. Priority Date: 07/18/1986
• Status: Expired due to Term

• Current Assignee: Purdue Frederick Company (Purdue Pharma L.P.), Purdue Pharma Company (Purdue Pharma L.P.), Purdue Pharma L.P., The PF Laboratories, Inc. (Purdue Pharma L.P.)
• Original Assignee: Euroceltique SA
• Inventors: Oshlack, Benjamin
• Primary Examiner(s): Page, Thurman K.
• Application Number:
  US07/333,309
• Time in Patent Office: 587 Days
• Field of Search: 424/484, 424/486, 424/487, 424/501, 424/502, 424/489, 424/451, 424/457, 424/458, 424/469, 424/470
• US Class Current: 424/451
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Abstract

The release of therapeutically active agents from controlled release bases is extended by using a combination of a higher aliphatic alcohol and an acrylic resin as the base material.

Claims

1. Extended action controlled release pharmaceutical composition for oral administration, comprising a pharmaceutically effective amount of a pharmaceutically active agent distributed in a controlled release core or matrix comprising a higher aliphatic alcohol of 10-18 carbon atoms and a pharmaceutically acceptable acrylic resin, said acrylic resin being present in an amount of about 10-60% by weight of the weight of said higher aliphatic alcohol plus said acrylic resin.

2. Pharmaceutical composition according to claim 1 wherein said acrylic resin is an amount of about 15-40% by weight.

3. Pharmaceutical composition according to claim 1 wherein said acrylic resin is in an amount of about 20-35% by weight.

4. Pharmaceutical composition according to claim 1 wherein said core or matrix also includes a binder in an amount sufficient to bind said composition.

5. Pharmaceutical composition according to claim 4 wherein said core or matrix also includes a filler.

6. Pharmaceutical composition according to claim 5 wherein said core or matrix also includes a disintegrant in a disintegrant effective amount.

7. Pharmaceutical composition according to claim 6 wherein said core or matrix also includes a lubricant.

8. Pharmaceutical composition according to claim 1 wherein said core or matrix constitutes about 20-40% by weight of said composition.

9. Pharmaceutical composition according to claim 1 wherein said pharmaceutically active agent is highly water soluble.

10. Pharmaceutical composition according to claim 1 and being in the form of a tablet.

11. Pharmaceutical composition according to claim 1 and being in the form of a caplet.

12. Pharmaceutical composition according to claim 1 and being in capsule form.

13. Core or matrix for controlled release pharmaceutical compositions for oral administration and being adapted for distribution therein of a pharmaceutically active agent, said core or matrix comprising a higher aliphatic alcohol of 10-18% carbon atoms and a pharmaceutically acceptable acrylic resin, said acrylic resin being in an amount of about 10-60% by weight of the weight of said higher aliphatic alcohol and said acrylic resin.

14. Core or matrix according to claim 13 wherein the amount of said acrylic resin is about 15-40% by weight.

15. Core or matrix according to claim 13 wherein the amount of said acrylic resin is about 20-35% by weight.