Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1993-06-23
1995-12-05
Webman, Edward J.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424461, 424495, 424408, 424418, 5147721, 514781, 427 216, 42721331, 4273722, 427377, 71 6407, 71 6413, A61K 914, A61K 916, A61K 936, A61K 962
Patent
active
054727120
ABSTRACT:
A stabilized solid controlled release formulation having a coating derived from an aqueous dispersion of a hydrophobic polymer is obtained by overcoating a substrate including an active agent selected from the group consisting of a systemically active therapeutic agent, a locally active therapeutic agent, a disinfecting and sanitizing agent, a cleansing agent, a fragrance agent and a fertilizing agent, with an aqueous dispersion of the plasticized hydrophobic polymer and then curing the coated substrate at a temperature above the glass transition temperature of the plasticized hydrophobic polymer, until a curing endpoint is reached at which the coated substrate provides a stabilized dissolution of the active agent which is unchanged after exposure to accelerated storage conditions, the endpoint being determined by comparing the dissolution profile of the formulation immediately after curing to the dissolution profile of the formulation after exposure to accelerated storage conditions of at least one month at a temperature of 37.degree. C. and at a relative humidity of 80%.
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J. B. Dressman, C. Jarvis, A. G. Ozturk, B. O. Palsson, and T. A. Wheatley 18th Int. Symposium on Controlled Release Of Bioactive Materials pp. 654-655, "Storage Effects on Release From Phenylpropanolamine HCl Pellets Coated With an Ethylcellulose-based Film", 1991, Amsterdam, Netherlands, Pub. by the Controlled Release Society, Inc.
Chasin Mark
Oshlack Benjamin
Pedi, Jr. Frank
Euroceltique S.A.
Webman Edward J.
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