Film coating

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills

Reexamination Certificate

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C424S490000, C424S473000

Reexamination Certificate

active

07959947

ABSTRACT:
A film coating composition suitable for use in coating pharmaceutical formulations comprising a) an acrylic polymer dispersion, e.g. an ethylacrylate/methylmethacrylate copolymer such as Eudragit NE30D, b) a surfactant, c) sodium stearyl fumarate, and d) a water-containing liquid useful for the achievement of controlled release from pharmaceutical formulations such as tablets, pellets, etc.

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Lin et al. (“study of Crystallization of Endogenous Surfactant in EUDRAGIT NE30D-Free films and its Influence on Drug-Release Properties of controlled-Release Diphenhydramine HCI pellets coated with EUDRAGIT NE30D,” in AAPS Pharmsci 2001: 3(2) article 14, provided by applicant in form 1449).
Handbook of pharmaceutical excipients, 4th eddition, 2003 provided by applicant.
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A.Y. Lin et al., “Study of crystallization of endogenous surfactant in Eudragit NE30D-free films and its influence on drug release properties of controlled-release diphenhydramine HCI pellets coated with Eudragit NE #)D”,AAPS Pharmsci 2001; 3(2) article 14.

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