Water soluble film for oral administration with instant wettability

• US 6,177,096 B1
• Filed: 04/06/1999
• Issued: 01/23/2001
• Est. Priority Date: 11/11/1996
• Status: Expired due to Term

• Current Assignee: LTS Lohmann Therapie-Systeme AG
• Original Assignee: LTS Lohmann Therapie-Systeme GmbH
• Inventors: Serino, Anthony, Guo, Jian-Hwa, Zerbe, Horst Georg
• Primary Examiner(s): Reamer, James H.
• Application Number:
  US09/287,181
• Time in Patent Office: 658 Days
• Field of Search: 424/435
• US Class Current: 424/435
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 8/39 Derivatives containing from 2 to 10 oxyalkylene groups
• CPC Class Codes: A61K 8/4926 having six membered rings
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• CPC Class Codes: A61K 8/8176 Homopolymers of N-vinyl-pyrrolidones. Compositions of derivatives of such polymers
• CPC Class Codes: A61K 8/90 Block copolymers A61K8/89 takes precedence
• CPC Class Codes: A61K 8/922 of vegetable origin
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 25/26 Psychostimulants, e.g. nicotine, cocaine
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• 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 composition containing therapeutic agents and/or breath freshening agents for use in the oral cavity is disclosed. The carrier comprises water-soluble polymers in combination with certain ingredients and provides a therapeutic and/or cosmetic effect. The film is coated and dried utilizing existing coating technology and exhibits instant wettability followed by rapid dissolution/disintegration upon administration in the oral cavity.

Claims

1. A composition applicable to the oral cavity comprising at least one water-soluble polymer, at least one polyalcohol, and at least one cosmetically or pharmaceutically active ingredient, wherein the composition has mucoadhesive properties.

2. The composition according to claim 1, wherein the cosmetically active ingredient is selected from the group consisting of breath freshening compounds, flavors used for oral hygiene, fragrances used for oral hygiene, active agents used for oral cleansing, and active agents used for dental cleansing.

3. The composition according to claim 1, wherein the water-soluble polymer is hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthane gum, tragacantha, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, or mixtures thereof.

4. The composition according to claim 1, wherein the concentration of the water-soluble polymer in the dry film is between 20 and 75%.

5. The composition according to claim 1, further comprising one or more plasticizers or surfactants.

6. The composition according to claim 5, wherein the surfactant comprises a polyoxyethylene sorbitan fatty acid ester or a α

-hydro-ω

-hydroxypoly(oxyethylene) poly(oxypropylene)poly(oxyethylene) block copolymer.

7. The composition according to claim 5, wherein the surfactant comprises a polyoxyethylene alkyl ether or a polyoxyethylene castor oil derivative.

8. The composition according to claim 1, wherein the polyalcohol is selected from glycerol, polyethylene glycol, propylene glycol, or glycerol monoesters with fatty acids.

9. The composition according to claim 1, wherein the pharmaceutically active ingredient is selected from the group of hypnotics, sedatives, antiepileptics, awakening agents, psychoneurotropic agents, neuromuscular blocking agents, antispasmodic agents, antihistaminics, antiallergics, cardiotonics, antiarrhythmics, diuretics, hypotensives, vasopressors, antitussive expectorants, thyroid hormones, sexual hormones, antidiabetics, antitumor agents, antibiotics and chemotherapeutics, or narcotics.