NDLI: Impact of Superdisintegrants and Film Thickness on Disintegration Time of Strip Films Loaded With Poorly Water-Soluble Drug Microparticles

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Impact of Superdisintegrants and Film Thickness on Disintegration Time of Strip Films Loaded With Poorly Water-Soluble Drug Microparticles

Content Provider	Scilit
Author	Zhang, Lu Aloia, Marie Pielecha-Safira, Barbara Lin, Honghao Rajai, Prarthana Manoj Kunnath, Kuriakose Davé, Rajesh N.
Copyright Year	2018
Description	Journal: Journal of Pharmaceutical Sciences Although strip films are a promising platform for delivery of poorly water-soluble drug particles via slurry casting, the effect of critical material attributes, for example, superdisintegrants (SDIs) on critical quality attributes, including film disintegration time (DT), remains underexplored. A 2-level factorial design is considered to examine the impact of the SDI type (sodium starch glycolate and croscarmellose sodium), their amount, and film thickness. SDIs were used with hydroxypropyl methylcellulose (E15LV) and glycerin solutions along with viscosity matching. Fenofibrate, a model poorly water-soluble drug, was micronized and surface modified via fluid energy milling. Significant decreases in film DT, measured using 3 different methods, were observed due to the addition of SDIs. Percentage reduction in DT was a strong function of SDI amount, and thinner films disintegrated faster. Films with either higher SDI concentrations (>9%) or films under 80 μm, exhibited fast DT (80% in 10 min). All films achieved good content uniformity, except for those with the lowest amount of SDI, attributed to insufficient viscosity and thickness nonuniformity due to the SDI. Finally, all films achieved adequate mechanical properties, notwithstanding minor negative impact of SDIs.
Related Links	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6047912/pdf http://jpharmsci.org/article/S0022354918302090/pdf
Ending Page	2118
Page Count	12
Starting Page	2107
ISSN	00223549
e-ISSN	15206017
DOI	10.1016/j.xphs.2018.04.006
Journal	Journal of Pharmaceutical Sciences
Issue Number	8
Volume Number	107
Language	English
Publisher	Elsevier BV
Publisher Date	2018-08-01
Access Restriction	Open
Subject Keyword	Journal: Journal of Pharmaceutical Sciences Pharmacology and Pharmacy Polymeric Drug Delivery Systems; Content Uniformity; Microparticles; Excipients; Viscosity; Dissolution; Mechanical Properties
Content Type	Text
Resource Type	Article
Subject	Pharmaceutical Science

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