METHOD FOR PREPARING A PHARMACEUTICAL PRODUCT

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 ind...

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Hauptverfasser: LANG, Steffen, TRITSCHLER, Patrick, PLOEGER, Dale, HOOK, David, PARKS, Jim, DI RENZO, Elodia, STEIGMILLER, Stefan, WEBER, Fabian, SCHNEIDER, Hendrik, OGORKA, Jörg, KRUMME, Markus, MORATTO, Massimo, RASENACK, Norbert, STOUT, Gordon
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung: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.