Method for preparing a pharmaceutical product

US11642315B2 · kind B2 · utility

Assignee

• Novartis AG · CH

Inventors

• Elodia Di Renzo · Basel, CH
• David Hook · Rheinfelden, CH
• Markus Krumme · Neuwied, DE
• Steffen Lang · Reinach, CH
• Massimo Moratto · Basel, CH
• Joerg Ogorka · Steinen, DE
• Jim Parks · Belmont, US
• Dale Ploeger · Menlo Park, US
• Norbert Rasenack · Weil am Rhein, DE
• Hendrik Schneider · Basel, CH
• Stefan Steigmiller · Freiburg (Elbe), DE
• Gordon Stout · Fresno, US
• Patrick Tritschler · Freiburg (Elbe), DE
• Fabian Weber · Freiburg (Elbe), DE

Key dates

• Filing date: Sep 28, 2018
• Grant date: May 9, 2023
• Expiry date: Oct 10, 2039

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K9/0053
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

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.