Drug preparation applicable to oral mucosa

• US 5,137,729 A
• Filed: 01/31/1990
• Issued: 08/11/1992
• Est. Priority Date: 01/31/1989
• Status: Expired due to Fees

• Current Assignee: Nitto Denko Corporation
• Original Assignee: Nitto Denko Corporation
• Inventors: Inoue, Yuichi, Kuroya, Takamasa
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Azpuru, Carlos
• Application Number:
  US07/472,933
• Time in Patent Office: 923 Days
• Field of Search: 424/81, 424/78, 424/443, 424/447, 424/448, 424/449, 424/484, 424/486, 424/487, 424/488, 424/435, 514/54, 514/57, 514/777, 514/778, 514/784, 514/785, 514/944, 514/945, 514/953, 514/955
• US Class Current: 424/435
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays

Abstract

A drug preparation applicable to the oral mucosa is disclosed, comprising a soft adhesive film containing a systemic drug, the adhesive 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 drug preparation is less causative of an adverse feeling in the oral cavity on use, excellent in shape retention on water absorption, and adhesive to the oral mucosa for an extended period of time, thereby achieving a stable administration of a systemic drug for a long time.

Claims

1. A drug preparation applicable to the oral mucosa, comprising a soft adhesive film containing a systemic drug, said adhesive 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, wherein said cellulose derivatie is selected from the group consisting of methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxy-propyl cellulose, and hydroxypropylmethyl cellulose.

2. A drug preparation as claimed in claim 1, wherein said acrylic acid polymer and cellulose derivative are present at a weight ratio of from 1/9 to 9.1.

3. A drug preparation as claimed in claim 2, wherein said acrylic acid polymer and cellulose derivative are present at a weight ration of from 3.7 to 6.4.

4. A drug preparation as claimed in claim 1, wherein a 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.

5. A drug preparation 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.

6. A drug preparation as claimed in claim 1, wherein said adhesive film further contains a salt or base neutralizing the acrylic acid polymer.

7. A drug preparation as claimed in claim 6, wherein said salt or base is present in an amount of from 0.03 to 0.2 equivalent to the acrylic acid polymer.

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

m.

9. A drug preparation as claimed in claim 2, wherein said preparation further comprises a water-insoluble soft film support laminated on said adhesive film.

10. A drug preparation as claimed in claim 9, wherein said support has a thickness of from 10 to 100 μ

m.

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

12. A drug preparation as claimed in claim 1, wherein said lower alcohol is selected from the group consisting of methanol and ethanol.