Stable pharmaceutical formulations of zonisamide and methods for their manufacture

摘要

One of the embodiments of the present invention is directed toward a process for preparing a stable zonisamide pharmaceutical composition, comprising subjecting zonisamide to wet granulation with a granulation liquid to form a granulated mixture as the stable zonisamide pharmaceutical composition, wherein the granulation liquid is selected from purified water, alcohol and mixtures thereof. The stable zonisamide pharmaceutical composition can be used to fill capsule shells to prepare stable zonisamide capsules. Another embodiment of the invention concerns a for preparing a stable zonisamide pharmaceutical capsule, comprising (i) forming an intimate mixture with zonisamide powder and an effective amount of at least one pharmaceutically acceptable excipient by compressing, co-milling, co-micronization and/or co-compaction of the components, or subjecting the components to a similarly intensive process; and (ii) filling capsule shells with the intimate mixture to obtain the stable zonisamide pharmaceutical capsule.