Sustained release oxycodone composition with acrylic polymer and metal hydroxide

• US 20070281017A1
• Filed: 06/06/2006
• Published: 12/06/2007
• Est. Priority Date: 06/06/2006
• Status: Abandoned Application

• Current Assignee: Endo Pharmaceuticals Incorporated (Endo International PLC)
• Original Assignee: Endo Pharmaceuticals Incorporated (Endo International PLC)
• Inventors: Kao, Huai-Hung, Zeng, Yadi, Jim, Fai, Chang, Sou-Chan
• Application Number:
  US11/447,714
• Publication Number:
  US 20070281017A1
• Time in Patent Office: Days
• US Class Current: 424/468
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• 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 invention is a controlled release composition comprising a therapeutic amount of an active ingredient in a controlled release matrix. The matrix comprises a combination of a pharmaceutically acceptable acrylic polymer and a metal hydroxide. The amount of metal hydroxide, relative to a given amount of acrylic polymer, is selected for and corresponds to a pre-determined release rate for said active ingredient. The compound is preferably used to provide controlled release dosage of oxycodone through a matrix of ammonio methacrylic polymer and magnesium hydroxide.

Claims

1. A controlled release composition comprising:

a controlled release matrix comprising;

a pharmaceutically acceptable acrylic polymer; and

a metal hydroxide

wherein the ratio of said metal hydroxide to said acrylic polymer is about 0.001-0.5 by weight.

2. The composition of claim 1 wherein the ratio of said metal hydroxide to said acrylic polymer is about 0.002-0.1 by weight.

3. The composition of claim 1 further comprising a therapeutic amount of an active ingredient.

4. The composition of claim 3 wherein said active ingredient is substantially evenly dispersed in said controlled release matrix.

5. The composition of claim 3 wherein said ingredient is selected from the group consisting of oxycodone, oxymorphone, morphine, levorphanol, codeine, hydrocodone, nalorphine, naloxone, naltreone, buprenorphine, butorphanol, nalbuphine and their pharmaceutically active salts.

6. The composition of claim 5 wherein said active ingredient is oxycodone or their pharmaceutically active salts.

7. The composition of claim 1 wherein said acrylic polymer is an ammonio methacrylate based polymer.

8. The composition of claim 1 wherein said metal hydroxide is selected from magnesium hydroxide and calcium hydroxide.

9. The composition of claim 1 wherein said metal hydroxide is present at about 0.1-5% by weight of said composition.

10. A controlled release pharmaceutical composition comprising:

a therapeutic amount of an active ingredient; and

a controlled release matrix comprising;

a pharmaceutically acceptable acrylic polymer; and

a metal hydroxide in an amount selected such that the ratio of said metal hydroxide to said acrylic polymer is about 0.001-0.5 by weight.

11. The composition of claim 10 wherein said acrylic polymer is an ammonio methacrylate based polymer.

12. The composition of claim 10 wherein said metal hydroxide is selected from magnesium hydroxide and calcium hydroxide.

13. The composition of claim 10 wherein said ratio of metal hydroxide to acrylic polymer is about 0.002-0.1.

14. The composition of claim 10 wherein said active ingredient is selected from the group consisting of oxycodone, oxymorphone, morphine, levorphanol, codeine, hydrocodone, nalorphine, naloxone, naltreone, buprenorphine, butorphanol, nalbuphine and their pharmaceutically active salts.

15. The composition of claim 10 wherein said active ingredient is oxycodone or its pharmaceutically active salts.

16. A controlled release therapeutic composition comprising:

a therapeutic amount of oxycodone or its pharmaceutically active salts; and

a controlled release matrix comprising;

a pharmaceutically acceptable ammonio methacrylate based polymer; and

magnesium hydroxide;

wherein the ratio of said magnesium hydroxide to said ammonio methacrylate based polymer is about 0.001-0.5 by weight.

17. The composition of claim 16 wherein said ratio of said magnesium hydroxide to said ammonio methacrylate based polymer is about 0.002-0.1 by weight.