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Claims for Patent: 4,966,768

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Claims for Patent: 4,966,768

Title: Sustained release etodolac
Abstract:A sustained release dosage form of etodolac is provided which is a tablet having as essential components etodolac, hydroxyproplymethylcellulose, ethylcellulose and a release rate modifying agent such as dibasic sodium phosphate, the hydroxyproplymethylcellulose having a hydroxypropoxyl content of about 7.0% to 8.6% by weight.
Inventor(s): Michelucci; John J. (Plattsburgh, NY), Sherman; Deborah M. (Plattsburgh, NY), DeNeale; Richard J. (Willsboro, NY)
Assignee: American Home Products Corporation (New York, NY)
Application Number:07/268,646
Patent Claims: 1. A sustained release dosage form useful in providing once-a-day medication which consists essentially of an admixture of a carrier base material with etodolac and a release rate modifying agent and shaped and compressed to a solid unit dosage form having a regular and prolonged release pattern upon administration, the carrier base material comprising about 18 to 30 weight percent of the solid dosage form and being hydroxypropylmethylcellulose in admixture with 15 to 28 weight percent of the admixture of ethylcellulose, wherein the hydroxypropylmethylcellulose has a hydroxypropoxyl content of about 7.0 to about 8.6 weight percent, a methoxyl content of about 19-24 weight percent, a 2% aqueous solution viscosity of 80 to 120 cps, and an average molecular weight of less than 50,000, the release rate modifying agent being an effective amount of a physiologically acceptable buffer acid, buffer acid salt or mixture thereof.

2. The composition according to claim 1 wherein the release rate modifying agent is dibasic sodium phosphate.

3. The composition of claim 1 wherein the carrier base material is within the range of about 18% to about 30% by weight of the solid unit dosage form.
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