METHOD OF PRODUCING DRUG-CONTAINING WAX MATRIX PARTICLES, EXTRUDER TO BE USED IN THE METHOD AND SUSTAINED-RELEASE PREPARATION CONTAINING CILOSTAZOL

• Main Authors: YAMAGUCHI, YASUO, TOMOHIRA, YUSO
• Format: Patent
• Language: English; French
• Published: 24.11.2015
• Subjects: BABY COMFORTERS; CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOIDCHEMISTRY; 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; PERFORMING OPERATIONS; PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; THEIR RELEVANT APPARATUS; TRANSPORTING

The present invention aims to provide a method for producing, by a simple method, drug-containing wax matrix granules, particularly drug-containing wax matrix granules having an average particle diameter of 1 mm or lower, while avoiding liquid blockage due to the recrystallization of a molten drug during the period from a melting step to a spray step. Drug-containing wax matrix granules having at least one wax and at least one drug are produced by the following steps (i) and (ii): (i) supplying the at least one drug and the at least one wax to an extruder in which the temperature of a barrel and the temperature of a die are adjusted to be higher than the melting point of the at least one wax; and (ii) while melting and kneading the at least one drug and the at least one wax in the extruder to give a molten kneaded drug and wax, spraying the molten kneaded drug and wax into an atmosphere having a temperature lower than the melting point of the wax from a spray nozzle directly mounted onto a die provided at a top end of the barrel of the extruder, thereby forming the mixture into granules.