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Challenges in Nanogrinding of Active Pharmaceutical Ingredients
Author(s) -
Bitterlich André,
Laabs Christina,
Busmann Eike,
Grandeury Arnaud,
Juhnke Michael,
Bunjes Heike,
Kwade Arno
Publication year - 2014
Publication title -
chemical engineering and technology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.403
H-Index - 81
eISSN - 1521-4125
pISSN - 0930-7516
DOI - 10.1002/ceat.201300697
Subject(s) - micronization , cinnarizine , grinding , active ingredient , bioavailability , materials science , process engineering , particle size , fenofibrate , chemical engineering , chromatography , chemistry , medicine , pharmacology , metallurgy , engineering
The production of nanosuspensions via stirred‐media milling has proved to be an effective method to overcome bioavailability challenges of poorly water‐soluble active pharmaceutical ingredients (APIs). The fine‐grinding of the APIs cinnarizine and fenofibrate was investigated. Important process parameters were varied and the influence on product quality was studied. Different challenges were identified prior to and during milling: Foaming inside the milling equipment and agglomeration of fenofibrate occurred, and a long‐term grinding experiment for cinnarizine revealed an increase in particle size, caused by ripening of the drug crystals during milling. Thus, the stability against ripening during the process is a newly identified challenge for the fine‐grinding of APIs.