Novartis Ag

Massimo Moratto

Philipp Lustenberger

Markus Krumme

David Hook

Gordon Stout

Norbert Rasenack

Joerg Ogorka

Steffen Lang

Zichen Jia

Marie Meyer

Hendrik Schneider

Stefan Steigmiller

Patrick Tritschler

Fabian Weber

Jim Parks

Elodia Di Renzo

Described herein is a crystalline hydrate form of LNP023 hydrochloride and to a process for its preparation. Furthermore, described herein is a pharmaceutical composition comprising the crystalline hydrate form of LNP023 hydrochloride, and at least one pharmaceutically acceptable excipient. The pharmaceutical composition described herein can be used to treat a disease and disorder mediated by complement activation.

Crystalline form of LNP023

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&#xb0;; (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.

Method for preparing a pharmaceutical product

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Basel, Switzerland

Massimo Moratto