EP0080879A2
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EP
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Pharmaceutical composition containing interferon in stable state
Assignee: Sunstar Inc
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Filing: 1982-11-26
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Granted: —
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Expires: 2002-11-26
Abstract
Abstract A pharmaceutical composition, such as pasta, gargle, gel, ointment, suppository, spray, etc., containing interferon in a stable state which comprises an effective amount of human interferon, a polyhydric (tri or higher) sugar alcohol as a stabilizer, and a conventional pharmaceutical carrier or diluent. Optionally, the composition can further contain as a stabilizer a material selected from the group consisting of acidic sugars and salts thereof, organic acid buffers, sulfur -containing mild reducing agents having sulfhydryl group selectivity, anionic surfactants and combinations thereof.
Inventors
- 👤 Kenji Hasegawa
- 👤 Yasuo Sakano
- 👤 Yasuhiro Katsuragi
- 👤 Kunio Sugihara
- 👤 Kenji Aimoto
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-25 17:24
CPC Classifications
A; A61; A61K; A61K47/00; A61K47/06; A61K47/26; A61K38/00; A61K38/16; A61K38/17; A61K38/19; A61K38/21; A61K9/00; A61K9/0012; A61K9/0014; Y; Y10; Y10S; Y10S435/00; Y10S435/811
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
34 words
A pharmaceutical composition containing interferon in a stable state which comprises an effective amount of human interferon, a polyhydric (tri or higher) sugar alcohol as a stabilizer, and a conventional pharmaceutical carrier or diluent.
Claim 2
Dependent Claim
34 words
A pharmaceutical composition containing interferon in a stable state which comprises an effective amount of human interferon, a polyhydric (tri or higher) sugar alcohol as a stabilizer, and a conventional pharmaceutical carrier or diluent.
Claim 3
Dependent Claim
47 words
A composition according to claim 1, wherein the polyhydric sugar alcohol is a member selected from the group consisting of glycerin, erythritol, arabitol, xylitol, sorbitol, mannitol and a mixture thereof and is formulated in an amount of 15 to 60 % by weight based on the composition.
Claim 4
Dependent Claim
47 words
or claim 2 3. A composition according to claim 1 /wherein the composition further includes as a stabilizer a material selected from the group consisting of acidic sugars and salts thereof, organic acid buffers, sulfur-containing mild reducing agents having sulfhydryl group selectivity, anionic surfactants and combinations thereof.
Claim 5
Dependent Claim
64 words
A composition according to claim 3, wherein the acidic sugar is a member selected from the group consisting of iduronic acid, galacturonic acid, glucuronic acid, guluronic acid, mannuronic acid, ketogluconic acid, ketogalactonic acid, ketogulonic acid, ascorbic acid, a salt thereof with alkali metals and a mixture thereof and is formulated in an amount of 0.01 to 1 % by weight based on the composition.
Claim 6
Dependent Claim
59 words
A composition according to claim 3, wherein the organic acid buffer 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 so as to adjust pH of the composition to 3 to 6.
Claim 7
Dependent Claim
57 words
A composition according to claim 3, herein the reducing agent is a member selected from the group consisting of thioctic acid, N-acetylcysteine, N-acetylhomocysteine, glutathione, thiodiglycollic acid, thioethanolamine, monothioglycerol, dithiothreitol, thioalkanoic acid having 1 to 7 carbon atoms and mixture thereof and is formulated in an amount of 0.001 to 0.1 % by weight based on the composition.
Claim 8
Dependent Claim
100 words
A composition according to claim 3, 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.
Claim 9
Dependent Claim
27 words
any one of claims 3 to 7, 8. A composition according to Lwherein the stabilizer is a mixture of the polyhydric sugar alcohol and the acidic sugar.
Claim 10
Dependent Claim
55 words
A composition according to any one of claims 3 to 7 wherein the stabilizer is one of the following mixtures:- the polyhydric sugar alcohol, the acidic sugar and the organic acid buffer; the polyhydric sugar alcohol, the acidic sugar and the reducing agent; or the polyhydric sugar alcohol, the acidic sugar and the anionic surfactant.
Claim 11
Dependent Claim
52 words
A composition according to any one of claims 3 to 7 wherein the stabilizer is a mixture of the polyhydric sugar alcohol, the acidic sugar, the organic acid buffer and the reducing agent, or a mixture of the polyhydric sugar alcohol, the acidic sugar, the organic acid buffer and the anionic surfactant.
Claim 12
Dependent Claim
36 words
A composition according to any one of claims 3 to 7 wherein the stabilizer is a mixture of the polyhydric sugar alcohol, the acidic sugar, the organic acid buffer, the reducing agent and the anionic surfactant.
Claim 13
Dependent Claim
78 words
A composition according to any one of the preceding claims which is in one of the following forms:- the form for application in the oral cavity; the form for topical application to the skin; the form for rectal administration; the form for vaginal administration; the form for urethral administration; the form for application to the eye; the form for application to the ear; the form for application to the nose; or the form for application to the throat.
Claim 14
Dependent Claim
44 words
A composition according to any one of the preceding claims wherein interferon having the specific activity of at least 1 x 10 5 IU/mg protein is formulated in an amount of at least 1 x 10 4 IU per 100 g of the composition.
References Cited (Backward Citations)
No citation records indexed.
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