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.
Highlights
Recent research has established polymer-based films as a drug delivery platform with several advantages over traditional solid oral dosage forms [1,2,3,4,5,6,7,8,9,10]
Thinner films require the use of small-sized drug particles for achieving more uniform drug particle distribution within the film matrix
The results revealed that the surface-modified particles promoted uniform dispersion of drug particles within the film matrix and led to better performance in drug particle re-dispersion, complete drug release, and drug content uniformity [6]
Summary
Recent research has established polymer-based films as a drug delivery platform with several advantages over traditional solid oral dosage forms [1,2,3,4,5,6,7,8,9,10]. The polymer films are considered to be patient compliant and self-administrable, among pediatric and geriatric patients. They are recognized as an inherently robust platform since the film-forming polymer acts as a flexible carrier for the drug particles. Has attracted significant attention for delivery of poorly water-soluble drugs. In this approach, crystalline drug particles are incorporated into a polymer solution by mixing, followed by casting, and drying. Thinner films require the use of small-sized drug particles for achieving more uniform drug particle distribution within the film matrix. Use of the fine particles poses challenges in manufacturing for achieving uniform drug distribution due to fine particle cohesion.
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