Composition and method for treating keratosic disorder of skin and mucosa

• US 4,605,555 A
• Filed: 09/20/1984
• Issued: 08/12/1986
• Est. Priority Date: 09/20/1984
• Status: Expired due to Term

• Current Assignee: Sunstar Kabushiki Kaisha
• Original Assignee: Sunstar Kabushiki Kaisha
• Inventors: Sakano, Yasuo, Sato, Mitsunobu, Katsuragi, Yasuhiro, Sugihara, Kunio, Aimoto, Kenji
• Primary Examiner(s): SCHAIN, HOWARD
• Application Number:
  US06/652,465
• Time in Patent Office: 691 Days
• Field of Search: 260/112 R, 424/85
• US Class Current: 424/85.4
• CPC Class Codes: A61K 38/21 Interferons [IFN]
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00

Abstract

A pharmaceutical composition for treating keratosic disorders of skin and mucosa, particularly, lichen planus and leukoplakia, by topical or local administration which comprises an effective amount of human interferon, a trihydric or more higher polyhydric sugar alcohol, an organic acid buffer and, optionally, an anionic surfactant and albumin, and a conventional pharmaceutical carrier or diluent. A method for treating a human subject suffering from keratosic disorders of skin and mucosa by using this composition is also provided.

Claims

1. A method for treating a human subject suffering from lichen planus or leukoplakia which comprises externally applying a pharmaceutical composition comprising an effective amount of human interferon, 15 to 70% by weight of a trihydric of higher polyhydric sugar alcohol, an organic acid buffer and a conventional pharmaceutical carrier or diluent, the pH of the composition being about 3 to 6.

2. A method according to claim 1, wherein the composition is applied in such an amount that 10 to 10⁸ IU of interferon is applied per single dosage.

3. A method according to claim 1, wherein the polyhydric sugar alcohol in the composition is a member selected from the group consisting of glycerin, erythritol, arabitol, xylitol, sorbitol, mannitol and a mixture thereof.

4. A method according to claim 1, wherein the organic acid buffer in the composition is a member selected from the group consisting of citrate buffer, succinate buffer, fumarate buffer, gluconate buffer, oxalate buffer, lactate buffer and acetate buffer and is formulated in an amount of 0.01 to 0.2 mole/kg composition.

5. A method according to claim 1, wherein the composition further includes an anionic surfactant.

6. A method according to claim 5, wherein the anionic surfactant is a member selected from the group consisting of sodium alkyl sulfate the alkyl group of which has 8 to 18 carbon atoms;

sodium polyoxyethylene alkyl ether sulfate the average number of mole of ethylene oxide added of which is 2 to 4 and the alkyl group of which has 8 to 18 carbon atoms;

sodium alkyl sulfosuccinate the alkyl group of which has 8 to 18 carbon atoms; and

a mixture thereof and is formulated in an amount of 0.008 to 4% by weight based on the composition.

7. A method according to claim 1, wherein the composition further includes albumin in an amount of 0.01 to 1% by weight based on the composition.

8. A method according to claim 1, wherein the composition is in the form of a solid and contains as a binder carboxymethyl cellulose.

9. A method according to claim 1, wherein the composition is in the form suitable for application in the oral cavity.