Patent EP0086093A1 successfully refreshed from Google Patents.
EP0086093A1
Expired / Lapsed
EP
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Long-lasting three layered pharmaceutical film preparations
Assignee: Ono Pharmaceutical Co Ltd
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Filing: 1983-02-04
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Granted: —
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Expires: 2003-02-04
Abstract
Abstract The present invention provides new three-layered pharmaceutical film preparations which comprise one drug-storing middle layer composed of one or more (a) polyvinylpyrrolidones, (b) hydroxypropyl celluloses, (c) plasticizers and (d) organic acids, containing prostaglandin analogues, and a release-controlling layer on each side of the said middle layer, composed of one or more (a) hydroxypropyl cellulose and (b) plasticizers, containing or not containing prostaglandin analogues, and which may release the drug at the desired concentration lastingly for an extended period of time, with great high biological availability, and can make this release "zero-order release", and further have improved the stability of the drug contained therein, and in which the form of the preparation is not retained at the administered site after administration.
Inventors
- 👤 Tatsushi Koide
- 👤 Seiei Sasatani
- 👤 Kohji Inaba
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-09 07:49
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/70; A61K9/7023; A61K9/703; A61K9/7038; A61K9/7046; A61K9/7053; A61K9/7092
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
58 words
A three-layered pharmaceutical film preparation which comprises one drug-storing middle layer composed of one or more (a) polyvinylpyrrolidones ,(b) hydroxypropyl celluloses,(c) plasticizers and (d) organic acids, containing prostaglandin analogue , and a release-controlling layer on each side of the said middle layer, composed of one or more (a) hydroxypropyl cellulosesand (b) plasticizers, containing or not containing prostaglandin analogue
Claim 2
Dependent Claim
58 words
A three-layered pharmaceutical film preparation which comprises one drug-storing middle layer composed of one or more (a) polyvinylpyrrolidones ,(b) hydroxypropyl celluloses,(c) plasticizers and (d) organic acids, containing prostaglandin analogue , and a release-controlling layer on each side of the said middle layer, composed of one or more (a) hydroxypropyl cellulosesand (b) plasticizers, containing or not containing prostaglandin analogue
Claim 3
Dependent Claim
18 words
A three-layered pharmaceutical film preparation according to claim 1, wherein the release-controlling layer does not contain prostaglandin analogues.
Claim 4
Dependent Claim
16 words
A three-layered pharmaceutical film preparation according to claim 1, wherein the release-controlling layer contains prostaglandin analogues.
Claim 5
Dependent Claim
21 words
A three-layered pharmaceutical film preparation according to claim 2 or 3, wherein the molecular weight of polyvinylpyrrolidone is 300,000 - 400,000.
Claim 6
Dependent Claim
22 words
A three-layered pharmaceutical film preparation according to claim 2 or 3, wherein the molecular weight of hydroxypropyl cellulose is 250,000 - 400,000.
Claim 7
Dependent Claim
23 words
A three-layered pharmaceutical film preparation according to claim 2 or 3, wherein the plasticizer is propylene glycol, glycerol, polyethylene glycol or lauryl alcohol.
Claim 8
Dependent Claim
21 words
A three-layered pharmaceutical film preparation according to claim 2 or 3, wherein the organic acid is citric acid or tartaric acid.
Claim 9
Dependent Claim
25 words
A three-layered pharmaceutical film preparation according to claim 2 or 3, wherein the prostaglandin analogue is a prostaglandin F compound or a prostaglandin E compound.
Claim 10
Dependent Claim
74 words
A three-layered pharmaceutical film preparation according to claim 2, wherein the drug-storing middle layer is composed of (a) polyvinylpyrrolidone having the molecular weight of 300,000 - 400,000, (b) hydroxypropyl cellulose having the molecular weight of 250,000 - 400,000, (c) polyethylene glycol and (d) citric acid, containing 16,16-dimethyl-trans-Δ 2 -PGE 1 methyl ester, and the release-controlling layer is composed of (a) hydroxypropyl cellulose having the molecular weight of 250,000 - 400,000 and (b) propylene glycol.
Claim 11
Dependent Claim
69 words
A three-layered pharmaceutical film preparation according to claim 2, wherein the drug-storing middle layer is composed of (a) polyvinylpyrrolidone having the molecular weight of 300,000 - 400,000, (b)hydroxypropyl cellulose having the molecular weight of 250,000 - 400,000, (c) lauryl alcohol and (d) tartaric acid, containing 16,16-dimethyl-trans-p2-PGE1 methyl ester, and the release-controlling layer is composed of (a) hydroxypropyl cellulose having the molecular weight of 250,000 - 400,000 and (b) glycerol.
Claim 12
Dependent Claim
124 words
A process for producing three-layered pharmaceutical film preparations which is characterized by mounting, by a laminating method, two sheets of a film of a release-controlling layer obtained by dissolving one or more hydroxypropyl celluloseshaving a molecular weight of 30,000 - 150,000 and one or more plasticizers in an organic solvent, and optionally adding a prostaglandin solution containing an organic acid dissolved in an organic solvent, and deaerating it, and further drying by a conventional method, and one sheet of a- film of a. drug-storing layer obtained by dissolving one or more polyvinylpyrrolidone, hydroxypropyl cellulose and plasticizers in an organic solvent, and adding a prostaglandin solution containing an organic acid dissolved in an organic solvent, and deaerating it, and further drying by a conventional method.
Claim 13
Dependent Claim
124 words
A process for producing three-layered pharmaceutical film preparations which is characterized by mounting, by a laminating method, two sheets of a film of a release-controlling layer obtained by dissolving one or more hydroxypropyl celluloseshaving a molecular weight of 30,000 - 150,000 and one or more plasticizers in an organic solvent, and optionally adding a prostaglandin solution containing an organic acid dissolved in an organic solvent, and deaerating it, and further drying by a conventional method, and one sheet of a- film of a. drug-storing layer obtained by dissolving one or more polyvinylpyrrolidone, hydroxypropyl cellulose and plasticizers in an organic solvent, and adding a prostaglandin solution containing an organic acid dissolved in an organic solvent, and deaerating it, and further drying by a conventional method.
Claim 14
Dependent Claim
147 words
A process for producing three-layered pharmaceutical film preparations which is characterized by mounting, by a laminating method, two sheets of a film of a release-controlling layer obtained by adding one or more plasticizers and hydroxypropyl celluloseshaving a. molecular weight of 250,000 - 400,000 in hot water, and suspending and dispersing homogeneously, and optionally adding a prostaglandin solution containing an organic acid dissolved in an organic solvent, and spreading out the obtained suspension as a layer having the uniform thickness, and then lowering its temperature below 45°C to obtain a homogeneous solution layer, and thereafter drying it with heating, and one sheet of a film of a drug-storing layer obtained by dissolving one or more polyvinylpyrrolidones, hydroxypropyl celluloses and plasticizers in an organic solvent, and adding a prostaglandin solution containing an organic acid dissolved in an organic solvent, and deaerating it, and further drying by a conventional method.
Claim 15
Dependent Claim
147 words
A process for producing three-layered pharmaceutical film preparations which is characterized by mounting, by a laminating method, two sheets of a film of a release-controlling layer obtained by adding one or more plasticizers and hydroxypropyl celluloseshaving a. molecular weight of 250,000 - 400,000 in hot water, and suspending and dispersing homogeneously, and optionally adding a prostaglandin solution containing an organic acid dissolved in an organic solvent, and spreading out the obtained suspension as a layer having the uniform thickness, and then lowering its temperature below 45°C to obtain a homogeneous solution layer, and thereafter drying it with heating, and one sheet of a film of a drug-storing layer obtained by dissolving one or more polyvinylpyrrolidones, hydroxypropyl celluloses and plasticizers in an organic solvent, and adding a prostaglandin solution containing an organic acid dissolved in an organic solvent, and deaerating it, and further drying by a conventional method.
References Cited (Backward Citations)
EP0050480A2
Cited
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