Nouvelle composition pharmaceutique à libération contrôlée par diffusion osmotique et son procédé de préparation

• Main Authors: DRABANT SANDOR, KIRALY NEE IGNACZ MARIA, KLEBOVICH IMRE, FEKETE PAL, SIPOS GABOR, UJFALUSSY GYORGY, KRISZTIAN MARIA, KISS NEE SZABO GIZELLA, MANDI ATTILA, GORA NEE HERNYES MAGDOLNA, BARCZAY ERZSEBET, JAMBOR NEE HOFFMANN ZSUZSANNA
• Format: Patent
• Language: French
• Published: 16.06.1995
• Edition: 6
• Subjects: BABY COMFORTERS; CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICALPURPOSES; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; DEVICES FOR RECEIVING SPITTLE; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGINGPHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL ORADMINISTERING FORMS; HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES

La composition pharmaceutique à libération contrôlée 10 consiste en un noyau de comprimé à une couche 12 et comporte un enrobage pelliculaire de polymère 11, un agent thérapeutique actif et un polymère hydrophile; elle peut aussi, consister en un noyau à deux couches, la première couche renfermant un agent actif et un polymère hydrophile, et la seconde couche un polymère hydrophile, avec au moins une ouverture 13 ménagée dans l'enrobage. Application à l'industrie pharmaceutique et notamment à l'élaboration de médicaments inhibiteurs beta-adrénergiques, angiotenso-inhibiteurs, anti-inflammatoires, vasodilatateurs, analgésiques ou ayant une action dans le traitement des troubles circulatoires et/ou du système nerveux. A subject-matter of the invention is a diffusion-osmotic controlled drug-release one-layer or two-layer pharmaceutical tablet core (10) containing one or more therapeutically active principle(s) and a hydrophilic polymer and being coated with a polymeric film-coat (11), in case of a two-layer tablet core containing the active principle(s) and hydrophilic polymer in the first layer (14) thereof and hydrophilic polymer in the second layer (15) thereof, and the tablet core (10) further having at least one bore (13; 16) on the film-coat (11) in contact with the tablet core (10) [in case of one-layer tablet core] or on the part of the film-coat (11) in contact with the first tablet core layer (14) containing the active principle(s) [in case of two-layer tablet core], characterized in that the hydrophilic polymer is hydroxypropyl-methylcellulose and the coating material of the film-coat (11) contains an ammonium methacrylate copolymer or a mixture of such. Furthermore according to the invention there is provided for a process for preparing these tablet cores.