Mucous membrane-adhering film preparation and process for its preparation

• US 4,517,173 A
• Filed: 05/25/1982
• Issued: 05/14/1985
• Est. Priority Date: 09/26/1980
• Status: Expired due to Fees

• Current Assignee: Nippon Soda Company Limited
• Original Assignee: Nippon Soda Company Limited
• Inventors: Ito, Akinori, Kobayashi, Jitsuo, Fujiyama, Norimasa, Kizawa, Hidenori
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US06/385,647
• Time in Patent Office: 1,085 Days
• Field of Search: 424/16, 424/28
• 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
• CPC Class Codes: A61L 2300/204 with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
• CPC Class Codes: A61L 2300/222 Steroids, e.g. corticosteroids
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 26/0023 Polysaccharides
• CPC Class Codes: A61L 26/0066 Medicaments; Biocides
• CPC Class Codes: A61L 26/0076 Sprayable compositions
• CPC Class Codes: C08L 1/26 Cellulose ethers

Abstract

A mucous membrane-adhering film preparation wherein the film consists of two layers. One layer of the film consists of the pharmaceutical agents and water-soluble high polymer material. The other layer of the film material consists of poor water-soluble agents. The pharmaceutical agent and water-soluble high polymer material layer first layer and the poor water-soluble agents second layer are separately prepared in solvents. The first solution is coated on a base plate having a favorable releasing nature, and, by removing the solvent, the film is produced on the base plate, the second solvent is then coated on the first layer and by removing the solvent, the desired film having one poor water-soluble surface is produced.

Claims

1. A mucous membrane-adhering film preparation with a flat contact side so formed as to be applied to an oral cavity and to adhere onto a mucous membrane, said preparation consisting of at least three layers, namely, a pharmaceutical layer (a), a poor water-soluble layer (b), and an intermediate layer (c), wherein:

(a) said pharmaceutical layer (a) is a material selected from the group consisting of predonisolone and allantoin together with water-solluble cellulose derivatives selected from the group consisting of hydroxypropyl cellulose, methyl cellulose, hydroxy propyl methyl cellulose and mixtures thereof, as a thin film base;

(b) said poor water-soluble layer (b) consists of water-soluble cellulose derivative together with poor-water-soluble components, said components being selected from the group consisting of shellack, higher fatty acids, and mixtures thereof; and

,

(c) said intermediate layer consists of water-soluble cellulose derivatives not containing a pharmaceutical agent and not-containing poor water-soluble components.

2. A preparation as claimed in claim 1 wherein the water-soluble cellulose derivatives are selected so as to have superior film moldability so as to produce a soft flexible film and the hydroxypropyl cellulose, methyl cellulose, hydroxy propyl methyl cellulose and mixtures thereof are so selected as to gradually discharge the effective components in the mouth.