| 摘要 |
<p>An orally disintegrating pharmaceutical composition comprising Asenapine, pharmaceutically acceptable salt or crystalline forms thereof, and at least one pharmaceutically acceptable excipient, which is free from binder, and a process for manufacturing the same, which comprises the following steps: a) mixing asenapine, pharmaceutically acceptable salt or crystalline forms thereof, the first part of a disintegrant, at least one diluent, at least one glidant, optionally a sweetener and /or a flavoring agent, b) wet granulation of the blend obtained in step a), c) screening and drying the granules, d) mixing the dried granules obtained in step c) with the second part of the disintegrant, at least one glidant, and optionally with a sweetener and/or flavoring agent, e) the blend obtained in step d) is lubricated with a lubricant, optionally flavoring agent is added, and f) optionally compressing the mixture obtained in step e) to form a tablet.</p> |
