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Claims for Patent: 4,389,393

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Claims for Patent: 4,389,393

Title: Sustained release therapeutic compositions based on high molecular weight hydroxypropylmethylcellulose
Abstract:A carrier base material combined with a therapeutically active medicament and shaped and compressed to a solid unit dosage form having a regular and prolonged release pattern upon administration, the carrier base material being one or more hydroxypropylmethylcelluloses or a mixture of one or more hydroxypropylmethylcelluloses and up to 30% by weight of the mixture of methylcellulose, sodium carboxymethylcellulose and/or other cellulose ether, and wherein at least one of the hydroxypropylmethylcelluloses has a methoxy content of 16-24 weight-%, a hydroxypropoxyl content of 4-32 weight-% and a number average molecular weight of at least 50,000 and wherein the carrier base material constitutes less than about one third of the weight of the solid unit dosage form.
Inventor(s): Schor; Joseph M. (Locust Valley, NY), Nigalaye; Ashok (Jackson Heights, NY), Gaylord; Norman G. (New Providence, NJ)
Assignee: Forest Laboratories, Inc. (New York, NY)
Application Number:06/362,104
Patent Claims: 1. A carrier base material combined with a therapeutically active medicament and shaped and compressed to a solid unit dosage form having a regular and prolonged release pattern upon administration, the carrier base material being one or more hydroxypropylmethylcelluloses or a mixture of one or more hydroxypropylmethylcelluloses and up to 30% by weight of the mixture of methyl cellulose, sodium carboxymethylcellulose and/or other cellulose ether, and wherein at least one of the hydroxypropylmethylcelluloses has a methoxy content of 16-24 weight-%, a hydroxypropoxyl content of 4-32 weight-% and a number average molecular weight of at least 50,000 and wherein the carrier base material constitutes less than about one third of the weight of the solid unit dosage form.

2. A composition according to claim 1 in which the carrier base material consists of a mixture of one or more hydroxypropylmethylcelluloses and 0-30% sodium carboxymethylcellulose.

3. A composition according to claim 1 in which the carrier base material consists of a mixture of one or more hydroxypropylmethylcelluloses and 0-30% of methylcellulose or other cellulose ether.

4. A composition according to claim 1 in which the active medicament is a moisture sensitive material.

5. A composition according to claim 4 in which the moisture sensitive medicament is selected from but not limited to aspirin, theophylline, phenacetin, procainamide, nikethamide, polymixin, barbiturates, idoxuridine, hydantoins, angiotensinamide, nitroglycerin, isosorbide dinitrate, benzocaine, scopolamine, meperidine, codeine, morphine, streptomycin, ascorbic acid, sulfonamide drugs, tolbutamide, chlorpheniramine, brompheniramine, phenylephrine, diphenhydramine, penicillins, tropine alkaloids, diethylcarbamazine, dihydroergotamine, caffeine, dexamethasone, and pharmaceutically acceptable salts of any of the above, alkaloid salts and adrenocortical steroid esters.

6. A composition according to claim 1 in which the active medicament is lithium carbonate.

7. A composition according to claim 1 in which the active medicament is phenylpropanolamine.

8. A composition according to claim 1 in which the active medicament is potassium chloride.

9. A composition according to claim 1 in which the active medicament is an anti-inflammatory drug selected from and not limited to ibuprofen, flurbiprofen, diclofenac, indomethacin and naproxen.

10. A method for the preparation of a therapeutically active solid unit dosage form having a regular and prolonged release pattern upon administration, consisting of compressing and shaping a mixture of a therapeutically active medicament and a carrier base material consisting of one or more hydroxypropylmethylcelluloses or a mixture of one or more hydroxypropylmethylcelluloses and up to 30% by weight of the mixture of methylcellulose, sodium carboxymethylcellulose or other cellulose ether, and wherein at least one of the hydroxypropylmethylcelluloses has a methoxyl content of 16-24 weight-%, a hydroxypropoxyl content of 4-32 weight-% and a number average molecular weight of at least 50,000, and wherein the carrier base material constitutes less than about one third of the weight of the solid unit dosage form.
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