Oral Controlled Release Formulation for Sedatives and Hypnotic Agents

• US 20090123535A1
• Filed: 12/04/2008
• Published: 05/14/2009
• Est. Priority Date: 03/02/2006
• Status: Abandoned Application

• Current Assignee: Dacheng Tian, Xiu Xiu Cheng
• Original Assignee: Dacheng Tian, Xiu Xiu Cheng
• Inventors: Cheng, Xiu Xiu, Tian, Dacheng
• Application Number:
  US12/328,240
• Publication Number:
  US 20090123535A1
• Time in Patent Office: Days
• US Class Current: 424/457
• CPC Class Codes: A61K 9/2846 Poly(meth)acrylates
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 25/20 Hypnotics; Sedatives

Abstract

The present invention relates to a novel controlled release dosage form that releases therapeutic amounts of a sedative or hypnotic agent rapidly after administration and maintains therapeutic levels for about eight hours after administration.

Claims

1. A controlled release oral dosage form for sedatives and hypnotic agents that maintains therapeutic levels for about four to eight hours after administration to a patient and release less than 40% of the sedative or hypnotic agent within 30 minutes when tested according to the United States Pharmacopeia 29 using Apparatus II (paddles), 900 ml of 0.01 N HCl at 50 rpms and 37°

C.

2. The controlled release oral dosage form for sedatives and hypnotic agents as defined in claim 1 wherein the dosage form releases not more than 35% of the sedative or hypnotic agent within 30 minutes when tested according to the United States Pharmacopeia 29 using Apparatus II (paddles), 900 ml of 0.01 N HCl at 50 rpms and 37°

C.

3. The controlled release oral dosage form for sedatives and hypnotic agents as defined in claim 1 wherein the dosage form releases not more than 30% of the sedative or hypnotic agent within 30 minutes when tested according to the United States Pharmacopeia 29 using Apparatus II (paddles), 900 ml of 0.01 N HCl at 50 rpms and 37°

C.

4. The controlled release dosage form as defined by claim 1 wherein the dosage form is a tablet.

5. The controlled release dosage form as defined by claim 4 wherein the dosage form is a matrix tablet coated with a pH dependent polymer.

6. The controlled release dosage form as defined by claim 1 wherein the dosage form is a capsule.

7-29. -29. (canceled)