Film applicable to oral mucosa and drug preparation comprising the same

• US 5,166,233 A
• Filed: 01/31/1990
• Issued: 11/24/1992
• Est. Priority Date: 01/31/1989
• Status: Expired due to Term

• Current Assignee: Nitto Denko Corporation, Sunstar Kabushiki Kaisha
• Original Assignee: Nitto Denko Corporation, Sunstar Company Limited
• Inventors: Inoue, Yuichi, Kuroya, Takamasa
• Primary Examiner(s): Nutter, Nathan M.
• Assistant Examiner(s): Mullis, Jeffrey Culpeper
• Application Number:
  US07/473,069
• Time in Patent Office: 1,028 Days
• Field of Search: 524/37, 524/42, 524/43, 524/44, 427/2, 427/3
• US Class Current: 524/37
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses

Abstract

A soft film applicable to the oral mucosa and a drug preparation comprising said film are disclosed, the film comprising a homogeneous mixture comprising a vinyl acetate homopolymer, an acrylic acid polymer, and a cellulose derivative capable of being dissolved in or swollen with water and a lower alcohol. The film or preparation is less causative of an adverse feeling on application to the oral mucosa, excellent in shape retention on water absorption, and adhesive to the oral mucosa for an extended period of time.

Claims

1. A film applicable to the oral mucosa, comprising a homogenous mixture comprising

(a) a vinyl acetate homopolymer,

(b) an acrylic acid polymer, and

(c) a cellulose derivative capable of being dissolved in or swollen with water and a lower alcohol, wherein said film further contains a salt or base neutralizing said acrylic acid polymer,

wherein said salt or base is present in an amount of from 0.03 to 0.2 equivalent to said acrylic acid polymer,

wherein said acrylic acid polymer and cellulose derivative are present at a weight ratio from 1/9 to 9/1, and wherein the lower alcohol is methanol or ethanol.

2. A film as claimed in claim 1, wherein said cellulose derivative is selected from the group consisting of methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose and hydroxypropylmethyl cellulose.

3. A film as claimed in claim 1, wherein said acrylic acid polymer and cellulose derivative are present at a weight ratio of from 3/7 to 6/4.

6. A film as claimed in claim 1, wherein said adhesive film has a thickness of from 5 to 500 μ

m.

7. A film as claimed in claim 1, wherein said film has a water-insoluble soft film support laminated on a side thereof.

8. A film as claimed in claim 7, wherein said support has a thickness of from 10 to 100 μ

m.

9. A film as claimed in claim 7, wherein said support is a polyethylene film, a vinyl acetate homopolymer film or an ethylene-vinyl acetate copolymer film.

4. A film applicable to the oral mucosa, comprising a homogenous mixture comprising

(a) a vinyl acetate homopolymer,

(b) an acrylic acid polymer, and

(c) a cellulose derivative capable of being dissolved in or swollen with water and a lower alcohol, wherein said film further contains a salt or base neutralizing said acrylic acid polymer,

wherein said salt or base is present in an amount of from 0.03 to 0.2 equivalent to said acrylic acid polymer,

wherein the weight ratio of said vinyl acetate homopolymer to the sum of said acrylic acid polymer and cellulose derivative is from 2/8 to 8/2, and wherein the lower alcohol is a methanol or ethanol.

5. A film as claimed in claim 4, wherein said acrylic acid polymer and cellulose derivative are present at a weight ratio of from 4/6 to 6/4.