4.7 Article

Dynamic and static curing of ethylcellulose: PVA-PEG graft copolymer film coatings

Journal

Publisher

ELSEVIER
DOI: 10.1016/j.ejpb.2011.02.010

Keywords

Controlled release; Film coating; Curing; Aqueous dispersion; Mathematical modeling; Ethylcellulose

Funding

  1. Nord-Pas de Calais Regional Council (Interdisciplinary Research Centre on Drug Products, PRIM: Pole de Recherche Interdisciplinaire pour le Medicament)

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When using aqueous polymer dispersions for the preparation of controlled-release film coatings, instability during long-term storage can be a crucial concern. Generally, a thermal after treatment is required to assure sufficient polymer particle coalescence. This curing step is often performed under static conditions in an oven, which is a time-consuming and rather cumbersome process. Dynamic curing in the fluidized bed presents an attractive alternative. However, yet little is known on the required conditions, in particular: temperature, time, and relative humidity, to provide stable film structures. The aim of this study was to better understand the importance of these key factors and to evaluate the potential of dynamic curing compared with that of static curing. Recently proposed ethylcellulose:poly(vinyl alcohol)-poly(ethylene glycol) graft copolymer (PVA-PEG graft copolymer) dispersions were coated on theophylline and metoprolol succinate-loaded starter cores, exhibiting different osmotic activity. Importantly, processing times as short as 2 h were found to be sufficient to provide long-term stable films, even upon open storage under stress conditions. For instance, 2-h dynamic curing at 57 degrees C and 15% relative humidity are assuring stable film structures in the case of theophylline matrix cores coated with 15% ethylcellulose:PVA-PEG graft copolymer 85:15. Importantly, the approach is also applicable to other types of drugs and starter cores, and the underlying drug release mechanisms remain unaltered. (C) 2011 Elsevier B.V. All rights reserved.

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