EP0266707A2
Expired / Lapsed
EP
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Sustained release labetalol tablet
Assignee: Merck Sharp & Dohme LLC
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Filing: 1987-10-31
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Granted: —
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Expires: 2007-10-31
Abstract
Abstract A sustained release dosage form of labetalol hydrochloride is disclosed comprising the active ingredient in a polymeric matrix of hydroxypropylmethylcellulose and polyvinylpyrrolidone and a pharmaceutically acceptable organic acid.
Inventors
- 👤 Surendra Sangekar
- 👤 Winston A. Vadino
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-06 04:46
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2004; A61K31/00; A61K31/16; A61K31/165; A61K31/166
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
43 words
An oral sustained release dosage unit form tablet comprising a therapeutically effective amount of labetalol hydrochloride; 5-20% by weight of a polymeric binder comprising a combination of hydroxypropylmethylcellulose and polyvinylpyrrolidone; 20-35% by weight of pharmaceutically acceptable organic acid; and optionally pharmaceutically acceptable excipients.
Claim 2
Dependent Claim
43 words
An oral sustained release dosage unit form tablet comprising a therapeutically effective amount of labetalol hydrochloride; 5-20% by weight of a polymeric binder comprising a combination of hydroxypropylmethylcellulose and polyvinylpyrrolidone; 20-35% by weight of pharmaceutically acceptable organic acid; and optionally pharmaceutically acceptable excipients.
Claim 3
Dependent Claim
46 words
An oral sustaned release dosage unit form tablet comprising a therapeutically effective amount of labetalol hydrochloride; 8-15% by weight of a polymeric binder comprising a combination of hydroxypropylmethylcellulose and polyvinylpyrrolidone; 25-30% by weight of pharmaceutically acceptable organic acid; and 0.5-3% by weight of pharmaceutically acceptable excipients.
Claim 4
Dependent Claim
46 words
An oral sustaned release dosage unit form tablet comprising a therapeutically effective amount of labetalol hydrochloride; 8-15% by weight of a polymeric binder comprising a combination of hydroxypropylmethylcellulose and polyvinylpyrrolidone; 25-30% by weight of pharmaceutically acceptable organic acid; and 0.5-3% by weight of pharmaceutically acceptable excipients.
Claim 5
Dependent Claim
21 words
The tablet of claim 1 wherein the polymeric binder comprises a weight ratio of 4 to 1 of hydroxypropylmethylcellulose to polyvinylpyrrolidone.
Claim 6
Dependent Claim
21 words
The tablet of claim 1 wherein the polymeric binder comprises a weight ratio of 2 to 1 of hydroxypropylmethylcellulose to polyvinylpyrrolidone.
Claim 7
Dependent Claim
27 words
The tablet of claim 1 wherein the pharmaceutically acceptable organic acid is selected from the group consisting of tartaric acid, citric acid, fumaric acid and maleic acid.
Claim 8
Dependent Claim
14 words
The oral sustained release tablet of claim 5 wherein the acid is tartaric acid.
Claim 9
Dependent Claim
14 words
The oral sustained release tablet of claim 5 wherein the acid is citric acid.
Claim 10
Dependent Claim
34 words
The tablet of claim 1 comprising 400 mg. of labetalol hydrochloride, 210 mg. of tartaric acid, 40 mg. of hydroxypropylmethylcellulose, 20 mg. of polyvinylpyrrolidone, 8 mg. of magnesium stearate and 2 mg. silica gel.
Claim 11
Dependent Claim
34 words
The tablet of claim 1 comprising 400 mg. of labetalol hydrochloride, 210 mg. of tartaric acid, 30 mg. of hydroxypropylmethylcellulose, 15 mg. of polyvinylpyrrolidone, 8 mg. of magnesium stearate and 2 mg. silica gel.
Claim 12
Dependent Claim
34 words
The tablet of claim 1 comprising 400 mg. of labetalol hydrochloride, 210 mg. of tartaric acid, 30 mg. of hydroxypropylmethylcellulose, 15 mg. of polyvinylpyrrolidone, 8 mg. of magnesium stearate and 2 mg. silica gel.
Claim 13
Dependent Claim
34 words
The tablet of claim 1 comprising 300 mg. of labetalol hydrochloride, 156 mg. of tartaric acid, 40 mg. of hydroxypropylmethylcellulose, 20 mg. of polyvinylpyrrolidone, 7 mg. of magnesium stearate and 2 mg. silica gel.
Claim 14
Dependent Claim
34 words
The tablet of claim 1 comprising 200 mg. of labetalol hydrochloride, 105 mg. of tartaric acid, 34 mg. of hydroxypropylmethylcellulose, 17 mg. of polyvinylpyrrolidone, 4 mg. of magnesium stearate and 1 mg. silica gel.
Claim 15
Dependent Claim
63 words
A process for preparing a stabilized oral sustained release dosage unit form tablet according to claim 1 which comprises: (a) blending labetalol hydrochloride with hydroxypropylmethylcellulose; (b) granulating the blended material from (a) with an aqueous solution of polyvinylpyrrolidone; (c) adding an organic acid and excipients to the granulate of (b) and mixing the materials (d) compressing the mixture of step (c) into tablets.
References Cited (Backward Citations)
No citation records indexed.
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