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

摘要

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.