MULTIPLE UNIT ORAL SUSTAINED RELEASE PREPARATION AND PROCESS FOR PRODUCTION OF THE SAME

摘要

[PROBLEMS] To provide a multiple unit oral sustained release preparation which can provide the controlled release of imidafenacin [4-(2-methyl-1-imidazolyl)-2,2-diphenylbutylamide] from the preparation to thereby sustain the pharmacological effect of imidafenacin and can avoid the rapid increase in the blood imidafenacin level. [MEANS FOR SOLVING PROBLEMS] A granule or powder having imidafenacin dispersed in a water-insoluble polymer or a higher alcohol can provide the controlled rate of diffusion of imidafenacin into water by the effect of the molecular network structure of the water-insoluble polymer or higher alcohol formed during the preparation of the granule or powder and, as a result, can provide the delayed release of imidafenacin from the granule or powder. A granule prepared by coating a seed granule with imidafenacin and further coating the granule with a water-insoluble polymer can also provide the controlled rate of diffusion of imidafenacin into water by the effect of the coating film formed from the water-insoluble polymer and, as a result, can provide the delayed release of imidafenacin from the granule. A multiple unit oral sustained release preparation in the form of a capsule or tablet which includes therein a granule or powder having controlled release of imidafenacin can provide the controlled release of imidafenacin for a prolonged period of time.