Enteric film coating composition containing enteric polymer...

A - Human Necessities – 61 – K

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A61K 9/26 (2006.01)

Patent

CA 2586425

Dry, enteric, film-coating compositions and aqueous dispersions containing the same are disclosed. When applied to orally-ingestible substrates such as oral solid dosage forms, the film coatings are capable of preventing the substrates from disintegrating in media with pH values from about 1 to about 4.5 or higher values. One preferred film-coating composition contains a micronized intermediate comprised of an acrylic resin and talc. Advantageously and surprisingly, the preferred film-coating composition does not contain an alkalizing agent.

Compositions d'enrobage d'un film gastrorésistant et sèches et dispersions aqueuses contenant celles-ci. Lors de leur application sur des substrats ingérables oralement, notamment des posologies orales solides, les enrobages de film sont aptes à éviter la désintégration des substrats dans des milieux à valeurs pH comprises entre 1 et environ 4,5 ou à des valeurs supérieures. Une composition d'enrobage de film préférée contient un intermédiaire micronisé constitué d'une résine acrylique et de talc. La composition d'enrobage de film préférée ne contient pas avantageusement et remarquablement un agent alkylisant.

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