Method for stabilizing preparation

• US 20030161873A1
• Filed: 11/21/2002
• Published: 08/28/2003
• Est. Priority Date: 05/24/2000
• Status: Active Grant

• Current Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Original Assignee: Otsuka Pharmaceutical Company Limited (Otsuka Holdings Company Limited)
• Inventors: Kashimoto, Minoru, Oka, Yoshikazu, Ichiba, Tetsuroh, Kuribayashi, Daisuke, Toguchi, Hajime, Mukai, Tadashi, Tomohira, Yuso, Nagasawa, Masakazu
• Granted Patent: US 7,867,514 B2
• Time in Patent Office: Days
• US Class Current: 424/452
• 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 stabilizing a 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 and basic substances.

2. The method according to claim 1, wherein at least one basic substance is incorporated into the preparation.

3. The method according to claim 2, wherein the basic substance is at least one member selected from the group consisting of silicates, carbonates, stearates, citrates, phosphates, metal oxides and metal hydroxides.

4. The method according to claim 3, wherein the basic substance is at least one member selected from the group consisting of citrates, metal oxides and metal hydroxides.

5. The method according to claim 1, wherein at least one compound selected from the group consisting of neutral salts and basic substances is incorporated in an amount of 0.01 wt % to 2000 wt % relative to the weight of sodium lauryl sulfate.

6. The method according to claim 5, wherein at least one compound selected from the group consisting of citrates, metal oxides and metal hydroxides is incorporated in an amount of 0.5 wt % to 1000 wt % relative to the weight of sodium lauryl sulfate.

7. (Amended) A pharmaceutical preparation comprising (1) a pharmacological substance, (2) sodium lauryl sulfate, (3) at least one basic substance selected from the group consisting of silicates, carbonates, citrates, phosphates, metal oxides and metal hydroxides, and (4) a stearate.

8. (Amended) The pharmaceutical preparation according to claim 7, wherein the basic substance is at least one member selected from the group consisting of citrates, metal oxides and metal hydroxides.

9. (Amended) The pharmaceutical preparation according to claim 8, wherein the basic substance is at least one member selected from the group consisting of magnecium oxide and sodium citerate.

10. (Amended) The pharmaceutical preparation according to claim 7, the preparation being in at least one dosage form selected from the group consisting of tablets, fine granules, granules, powder, pills and capsules.

11. (Amended) The pharmaceutical preparation according to claim 7, wherein (3) the basic substance is incorporated in an amount of 0.01 wt % to 2000 wt % relative to the weight of (2) sodium lauryl sulfate.

12. (Amended) The pharmaceutical preparation according to claim 11, wherein (3) the basic substance is incorporated in an amount of 0.5 wt % to 1000 wt % relative to the weight of (2) sodium lauryl sulfate.