Fast drying of biocompatible polymer films loaded with poorly water-soluble drug nano-particles via low temperature forced convection
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- 作者：Ramana Susarla ; Lucas Sievens-Figueroa ; Anagha Bhakay ; Yueyang Shen ; Jackeline I. Jerez-Rozo ; William Engen ; Boris Khusid ; Ecevit Bilgili ; Rodolfo J. Roma?ach ; Kenneth R. Morris ; Bozena Michniak-Kohn ; Rajesh N. Dav¨¦
- 关键词：Nanosuspensions ; BCS class II drugs ; Pharmaceutical films ; Convective drying ; Fast dissolution
- 刊名：International Journal of Pharmaceutics
- 出版年：2013
- 出版时间：15 October, 2013
- 年：2013
- 卷：455
- 期：1-2
- 页码：93-103
- 全文大小：1670 K
文摘
Fast drying of nano-drug particle laden strip-films formed using water-soluble biocompatible polymers via forced convection is investigated in order to form films having uniform drug distribution and fast dissolution. Films were produced by casting and drying a mixture of poorly water soluble griseofulvin (GF) nanosuspensions produced via media milling with aqueous hydroxypropyl methylcellulose (HPMC E15LV) solutions containing glycerin as a plasticizer. The effects of convective drying parameters, temperature and air velocity, and film-precursor viscosity on film properties were investigated. Two major drying regimes, a constant rate period as a function of the drying conditions, followed by a single slower falling rate period, were observed. Films dried in an hour or less without any irreversible aggregation of GF nanoparticles with low residual water content. Near-infrared chemical imaging (NIR-CI) and the content uniformity analysis indicated a better drug particle distribution when higher viscosity film-precursors were used. Powder X-ray diffraction showed that the GF in the films retained crystallinity and the polymorphic form. USP IV dissolution tests showed immediate release (¡«20 min) of GF. Overall, the films fabricated from polymer-based suspensions at higher viscosity dried at different conditions exhibited similar mechanical properties, improved drug content uniformity, and achieved fast drug dissolution.