Controlled release pharmaceutical preparation and method for producing the same

• US 5,068,112 A
• Filed: 03/24/1989
• Issued: 11/26/1991
• Est. Priority Date: 03/31/1988
• Status: Expired due to Term

• Current Assignee: Tanabe Seiyaku Co Ltd (Mitsubishi Chemical Group Corp.)
• Original Assignee: Tanabe Seiyaku Co Ltd (Mitsubishi Chemical Group Corp.)
• Inventors: Yoshino, Hiroyuki, Hirakawa, Yoshiyuki, Noda, Kazuo, Samejima, Masayoshi
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): BROUILLETTE, D GABRIELLE
• Application Number:
  US07/329,408
• Time in Patent Office: 977 Days
• Field of Search: 424/473
• US Class Current: 424/495
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/5078 with drug-free core

Abstract

Disclosed is a controlled release pharmaceutical preparation, comprising a core containing a pharmaceutically active ingredient, and a porous film of a hydrophobic polymeric substance or a hydrophobic polymeric substance and a hydrophilic polymeric substance, the core being coated with the porous film. Disclosed is also a method for producing the same. The controlled release pharmaceutical preparation of this invention posseses a desired dissolution rate by controlling the porosity of the porous film.

Claims

1. A controlled release pharmaceutical preparation comprising:

(A) a core containing a pharmaceutically active ingredient and succinic acid; and

(B) a porous cellulose film formed on the surface of said core by spraying a water-organic solvent mixture containing ethyl cellulose or a mixture of ethyl cellulose and hydroxypropyl cellulose, said porous cellulose film having a porosity of about 0.4 to 0.9 calculated according to the formula;

##EQU2##

2. The preparation according to claim 1, wherein said porous film has a porosity of about 0.5 to 0.85.

3. The preparation according to claim 1, wherein said porous film comprises ethyl cellulose.

4. The preparation according to claim 1, wherein said porous film comprises ethyl cellulose and hydroxypropyl cellulose.

5. The preparation according to claim 4, wherein said porous film comprises 0.05 to 0.5 part by weight of said hydroxypropyl cellulose per 1 part by weight of said ethyl cellulose.

6. A method of producing a controlled release pharmaceutical preparation which comprises spray-coating a water-organic solvent mixture containing ethyl cellulose or a mixture of ethyl cellulose and hydroxypropyl cellulose onto the surface of a core containing a pharmaceutically active ingredient and succinic acid to produce a porous cellulose film on said core, said porous cellulose film having a porosity of about 0.4 to 0.9 calculated according to the formula:

##EQU3##