期刊
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
卷 126, 期 -, 页码 149-158出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.ejpb.2017.04.014
关键词
Instant ODF powder; Individualized medication; Orodispersible films; Nanoparticle-loaded ODF; Process integration
资金
- Niedersachsische Ministerium fur Wissenschaft and Kultur (Germany)
The individualization of solid dosage forms to realize a flexible therapy for all patient groups is a topic which increasingly gains importance in pharmaceutical research. The goal of this study was to develop a nanoparticulate, instant orodispersible film (iODF) powder which can easily be reconstituted in water to cast ODFs containing an individualized concentration of an active pharmaceutical ingredient (API). It was shown that the processing of the film casing mass to iODF powders by spray drying provides the same advantageous film properties, particles sizes redispersed from the ODE and dissolution profiles as compared to the common production route. Due to the realization of nanoparticle loads up to 50 wt.% in the iODF powders, high API loads (11.8 mg cm(-2)) are achieved in final ODFs. The powders are well storable at different temperatures for at least three months and do not change their crystalline state during storage. Furthermore, dissolution of a defined amount of API from ODFs was found to be the fastest with the highest drug loads in the films. (C) 2017 Elsevier B.V. All rights reserved.
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