公开(公告)号：US11642315B2

公开(公告)日：2023-05-09

申请号：US16652097

申请日：2018-09-28

申请人： NOVARTIS AG

发明人： 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 Weber

IPC分类号： A61K9/48 ,  A61J3/07 ,  A61K9/00

CPC分类号： A61K9/4833 ,  A61J3/074 ,  A61K9/0053

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.

公开(公告)号：US20200315973A1

公开(公告)日：2020-10-08

申请号：US16652097

申请日：2018-09-28

申请人： NOVARTIS AG

发明人： 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 Weber

IPC分类号： A61K9/48 ,  A61J3/07

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.