Method for stabilizing preparation

• US 7,867,514 B2
• Filed: 05/23/2001
• Issued: 01/11/2011
• Est. Priority Date: 05/24/2000
• Status: Expired due to Fees

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Inventors: Mukai, Tadashi, Kashimoto, Minoru, Oka, Yoshikazu, Ichiba, Tetsuroh, Tomohira, Yuso, Kuribayashi, Daisuke, Nagasawa, Masakazu, Toguchi, Hajime
• Primary Examiner(s): Tran; Susan T
• Application Number:
  US10/276,294
• Publication Number:
  US 20030161873A1
• Time in Patent Office: 3,520 Days
• Field of Search: 424/484
• US Class Current: 424/464
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

Disclosed is a method for stabilizing a solid pharmaceutical preparation containing a pharmacological substance and sodium lauryl sulfate, the method comprising incorporating into the preparation at least one member selected from the group consisting of neutral salts, basic salts and basic substances. The preparation containing sodium lauryl sulfate prepared by the method of the invention has superior performance, including high storage stability, suppression of discoloration and deterioration, and prevention of change in its properties, such as the dissolution rate of pharmacological substance from the preparation.

Claims

1. A method for suppressing discoloration and deterioration of a pharmaceutical preparation caused by sodium lauryl sulfate being contained therein, the method comprising incorporating at least one basic substance selected from the group consisting of metal silicates, metal oxides, and metal hydroxides into a preparation that contains a pharmacological substance, sodium lauryl sulfate, and at least one cellulose selected from a group consisting of low-substituted hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxypropyl cellulose and crystalline cellulose,

wherein the incorporation of at least one basic substance selected from the group consisting of metal silicates, metal oxides, and metal hydroxides suppresses discoloration and deterioration of a pharmaceutical preparation caused by sodium lauryl sulfate, and

the pharmaceutical preparation contains 3 to 9 parts by weight of the basic substance per 80 parts by weight of the pharmacological substance.

2. The method according to claim 1, wherein said at least one basic substance selected from the group consisting of metal silicates, metal oxides, and metal hydroxides is incorporated in an amount of 0.5 wt % to 99 wt % relative to the weight of sodium lauryl sulfate.

3. The method according to claim 1, wherein the pharmacological substance is cilostazol.