Elodia Di Renzo,David Hook,Markus Krumme,Steffen Lang,Massimo Moratto,Joerg Ogorka,Jim Parks,Dale Ploeger,Norbert Rasenack,Hendrik Schneider,Stefan Steigmiller,Gordon Stout,Patrick Tritschler,Fabian W
申请号：
US16652097
公开号：
US20200315973A1
申请日:
2018.09.28
申请国别(地区):
US
年份:
2020
代理人:
摘要：
A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) complying with at least five of the following parameters determined by using a FT4 powder rheometer: (i) specific basic flow energy of at most 60 mJ/g； (ii) stability index of 0.75 to 1.25； (iii) specific energy of at most 10 mJ/g； (iv) major principle stress at 15 kPa of at most 40； (v) flow function at 15 kPa of at least 1.3； (vi) consolidated bulk density at 15 kPa of at least 0.26 g/mL； (vii) compressibility of at most 47%； and (viii) wall friction angle of at most 40°； (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device； and (c) encapsulating the bottom part, thereby producing a pharmaceutical product.
