Rosaleen MCLAUGHLIN,Simon Andrew Martyn HOWES,Craig WHEADON,Jonathon WHITEHOUSE
申请号：
US16797927
公开号：
US20200268667A1
申请日:
2020.02.21
申请国别(地区):
US
年份:
2020
代理人:
摘要：
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions using solventless mixing methods. Excess coating material that is not bound to a coated API particle may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Specifically, a coating ratio and/or a dosing ratio can be used to minimize the residual amount of excess unbound coating material to minimize agglomeration of coating material during storage. In some embodiments, a pharmaceutical composition is provided, the pharmaceutical composition comprising: 65-85 % w/w API particles； 15-30 % w/w coating material coating the API particles； and 3-15 % w/w matrix surrounding the coated API particles, wherein the pharmaceutical composition comprises a disintegration time rate of less than 10 seconds for at least six months under storage conditions of at least 25° C. and at least 60 % relative humidity.
