Impact of mixing on content uniformity of thin polymer films containing drug micro-doses
Document Type
Article
Publication Date
6-1-2021
Abstract
The impact of mixer type and critical process parameters (CPPs) on critical quality attributes (CQAs), including the drug content uniformity (CU) of slurry-cast polymer films loaded with micro-sized poorly water-soluble drugs were investigated. Previously untested hypothesis was that the best mixer at suitable CPPs promotes uniform drug dispersion within film precursors leading to acceptable dried-film CU at low, ~0.6 wt% drug concentrations. Taguchi design was utilized to select the best of three mixers; low-shear impeller, high-shear planetary, and high-intensity vibrational, for dried-film drug concentration of ~23 wt%. As-received fenofibrate, a model poorly water-soluble drug (~6 µm) was directly mixed with the hydroxypropyl methylcellulose (HPMC) and glycerin aqueous solution. Impeller and planetary mixers yielded desirable film relative standard deviation (RSD), while vibrational mixer could not. For the lowest dried-film drug concentration of ~0.6 wt%, only planetary mixer yielded RSD <6%. The precursor drug homogeneity was a sufficient but not a necessary condition for achieving dried-film RSD <6%. Thus, proper selection of mixer and its CPPs assured desirable film CQAs. However, minor drug particle aggregation was identified via re-dispersion testing which also led to incomplete drug release.
Identifier
85107857959 (Scopus)
Publication Title
Pharmaceutics
External Full Text Location
https://doi.org/10.3390/pharmaceutics13060812
e-ISSN
19994923
Issue
6
Volume
13
Grant
0540855
Fund Ref
National Science Foundation
Recommended Citation
Buyukgoz, Guluzar G.; Castro, Jeremiah N.; Atalla, Andrew E.; Pentangelo, John G.; Tripathi, Siddharth; and Davé, Rajesh N., "Impact of mixing on content uniformity of thin polymer films containing drug micro-doses" (2021). Faculty Publications. 4057.
https://digitalcommons.njit.edu/fac_pubs/4057