Method for producing osmosis-controlled tablets avoiding the use of chlorinated hydrocarbons

• Main Authors: KIRALY MARIA, JAMBOR ZSUZSANNA, FEKETE PAL, SIPOS GABOR, GORA MAGDOLNA, UJFALUSSY GYORGY
• Format: Patent
• Language: English; Spanish
• Published: 16.05.1998
• 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

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. NUEVAS COMPOSICIONES FARMACEUTICAS DE LIBERACION DE FARMACO CONTROLADA POR DIFUSION-OSMOSIS Y PROCESOS PARA PREPARAR LAS MISMAS. LA INVENCION SE REFIERE A UN NUEVO COMPUESTO FARMACEUTICO DE LIBERACION DE FARMACOS CONTROLADA POR DIFUSION-OSMOSIS, QUE CONTIENE UN NUCLEO DE TABLETA DE UNA O DOS CAPAS, INCLUYENDO UNA PELICULA DE RECUBRIMIENTO POLIMERICO, UNA SUSTANCIA TERAPEUTICAMENTE ACTIVA Y UN POLIMERO HIDROFILO; CON UNO O MAS AGUJEROS EN LA PELICULA DE RECUBRIMIENTO QUE ESTA EN CONTACTO CON EL NUCLEO, O CON EL POLIMERO HIDROFILO, QUE COMPRENDE UN COPOLIMERO DE METACRILATO AMONICO COMO MATERIAL DE RECUBRIMIENTO Y COMO POLIMERO HIDROFILO HIDROXIPROPIL-METIL-CELULOSA. EL COMPUESTO DESCRITO ES UTIL PARA PREPARAR TABLETAS DE LIBERACION DE FARMACO CONTROLADA QUE CONTIENEN COMO SUBSTANCIA ACTIVA FARMACOS UTILIZADOS PARA LAS ENFERMEDADES DEL CORAZON Y CIRCULATORIAS O QUE ACTUAN SOBRE EL SISTEMA NERVIOSO CENTRAL. LA INVENCION SE REFIERE ADEMAS A UN PROCESO PARA LA PREPARACION DE LOS COMPUESTOS ARRIBA INDICADOS.