Sustained release tablet

• US 5,593,694 A
• Filed: 06/24/1994
• Issued: 01/14/1997
• Est. Priority Date: 10/04/1991
• Status: Expired due to Fees

• Current Assignee: Mitsubishi Pharma Corporation (Mitsubishi Chemical Group Corp.)
• Original Assignee: Yoshitomi Pharmaceutical Industries, Ltd. (UBE Corporation)
• Inventors: Tomoyuki, Omura, Kikumaru, Kadoya, Hayashida, Tomohiro
• Primary Examiner(s): Spear, James M.
• Application Number:
  US08/211,587
• Time in Patent Office: 935 Days
• Field of Search: 424/480, 424/464, 424/474, 424/475, 424/479, 424/482, 424/468
• US Class Current: 424/468
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

A sustained release tablet comprising a base tablet comprising a water-swellable gelling agent and a pharmaceutically active ingredient dispersed homogeneously in said gelling agent, said base tablet being coated with a film coating composition prepared by dissolving one or two members selected from the group consisting of ethylcellulose and acetylcellulose in an organic solvent. The tablet is capable of zero order dissolution of both water-soluble drugs and slightly water-soluble drugs, and can be produced economically with ease.

Claims

1. A zero order dissolution sustained release tablet comprising a base tablet comprising a water-swellable gelling agent in a proportion of not less than 20% by weight per base tablet and a pharmaceutically active ingredient dispersed homogeneously in said gelling agent, said base tablet being coated with a film coating composition consisting essentially of one prepared by dissolving at least one member selected from the group consisting of ethylcellulose and acetylcellulose as a main component in an organic solvent, wherein the film coating composition is used in a proportion of 0.5-15% by weight relative to the base tablet, the thickness of the film is 0.002-0.05 mm at the side and 0.003-0.06 mm at the top or the bottom, and the ratio of the film thickness at the side to that at the top or the bottom is 0.55-0.85.

3. The sustained release tablet of claim 1, wherein the water-swellable gelling agent is added in a proportion of 31.1-82.5% by weight per base tablet.

4. The sustained release tablet of claim 1, wherein the water-swellable gelling agent is one to three members selected from the group consisting of hydroxypropylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, aminoacrylmethacrylate copolymer RS and an emulsion of ethyl acrylate and methyl methacrylate copolymer.

5. The sustained release tablet of claim 1, wherein the water-swellable gelling agent is hydroxypropylmethylcellulose.

6. The sustained release tablet of any one of claims 1, 3, 4 and 5, wherein the pharmaceutically active ingredient is one or two members selected from the group consisting of phenylpropanolamine hydrochloride, acetaminophen, ethenzamide, cloperastine hydrochloride and pranoprofen.

2. A zero order dissolution sustained release tablet comprising a base tablet comprising a water-swellable gelling agent in a proportion of not less than 20% by weight per base tablet and a pharmaceutically active ingredient dispersed homogeneously in said gelling agent, said base tablet being coated with a film coating composition consisting essentially of one prepared by dissolving at least one member selected from the group consisting of ethylcellulose and acetylcellulose, and polyethylene glycol in an organic solvent, wherein the film coating composition is used in a proportion of 0.5-15% by weight relative to the base tablet, the thickness of the film is 0.002-0.05 mm at the side and 0.003-0.06 mm at the top or the bottom, and the ratio of the film thickness at the side to that at the top or the bottom is 0.55-0.85.

7. The sustained release tablet of claim 2, wherein the water-swellable gelling agent is added in a proportion of 31.1-82.5% by weight per base tablet.

8. The sustained release tablet of claim 2, wherein the water-swellable gelling agent is one to three members selected from the group consisting of hydroxypropylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, aminoacrylmethacrylate copolymer RS and an emulsion of ethyl acrylate and methyl methacrylate copolymer.

9. The sustained release tablet of claim 2, wherein the water-swellable gelling agent is hydroxypropylmethylcellulose.

10. The sustained release tablet of any one of claims 2, 7, 8 and 9, wherein the pharmaceutically active ingredient is one or two members selected from the group consisting of phenylpropanolamine hydrochloride, acetaminophen, ethenzamide, cloperastine hydrochloride and pranoprofen.