公开(公告)号：US11642315B2

公开(公告)日：2023-05-09

申请号：US16652097

申请日：2018-09-28

Applicant: NOVARTIS AG

Inventor： 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: A61K9/48 ,  A61J3/07 ,  A61K9/00

CPC classification number: A61K9/4833 ,  A61J3/074 ,  A61K9/0053

Abstract: 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

Applicant: NOVARTIS AG

Inventor： 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: A61K9/48 ,  A61J3/07

Abstract: 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：US20200306198A1

公开(公告)日：2020-10-01

申请号：US16652107

申请日：2018-09-28

Applicant: NOVARTIS AG

Inventor： Florian Beck ,  Hans de Waard ,  Sarah Gold ,  Stefan Hirsch ,  David Hook ,  Nikhil Kavimandan ,  Markus Krumme ,  Steffen Lang ,  Detlef Moll ,  Siddharthya Mujumdar ,  Anh-Thu Nguyen-Trung ,  Joerg Ogorka ,  Norbert Rasenack ,  Raphael Tobler ,  Patrick Tritschler

IPC: A61K9/48

Abstract: A formulation for injection molding of a pharmaceutical carrier comprises 43.5-97% (w/w) of one or more polyethylene oxide polymer having a weight average molecular weight of MW 94,000-188,000; and optionally one or more excipients.

公开(公告)号：US20200246272A1

公开(公告)日：2020-08-06

申请号：US16652088

申请日：2018-09-28

Applicant: NOVARTIS AG

Inventor： Florian Beck ,  Hans de Waard ,  Sarah Gold ,  Stefan Hirsch ,  David Hook ,  Nikhil Kavimandan ,  Markus Krumme ,  Steffen Lang ,  Detlef Moll ,  Siddharthya Mujumdar ,  Anh-Thu Nguyen-Trung ,  Joerg Ogorka ,  Norbert Rasenack ,  Raphael Tobler ,  Patrick Tritschler

IPC: A61K9/48

Abstract: A pharmaceutical carrier (20) comprises a lid part (22) and a bottom part (24), wherein at least one of the lid part (22) and the bottom part (24) has a first wall section (26, 30) with a thickness of 180-250 μm, preferably 185-225 μm, even more preferably 190-220 μm, and most preferably about 215 μm, and a second wall section (28, 32) with a thickness of 350-450 μm, preferably 375-425 μm, more preferably 390-410 μm, and most preferably about 400 μm. The first wall section (26) of the lid part (22) defines an entire top portion of the lid part (22). Alternatively or additionally thereto, the first wall section (30) of the bottom part (24) defines an entire bottom portion of the bottom part (24).

公开(公告)号：US20220202728A1

公开(公告)日：2022-06-30

申请号：US17600318

申请日：2020-04-01

Applicant: NOVARTIS AG

Inventor： Florian BECK ,  Hans de Waard ,  Sarah Gold ,  Stefan Hirsch ,  David Hook ,  Nikhil Kavimandan ,  Markus Krumme ,  Steffen Lang ,  Detlef MOLL ,  Siddharthya Mujumdar ,  Anh-Thu Nguyen-Trung ,  Joerg Ogorka ,  Norbert Rasenack ,  Maxime Thomas-Schrapp ,  Raphael TOBLER ,  Patrick Tritschler

IPC: A61K9/48 ,  A61K47/32 ,  A61K47/36 ,  A61K47/12 ,  A61K47/10

Abstract: A formulation for injection moulding of a pharmaceutical carrier comprising 27-85% (w/w) of polyvinyl alcohol, and 10-60% (w/w) of a disintegration aid selected from maize starch, wheat starch, and combinations thereof; and optionally one or more excipients.