Colorcon Inc. Global Headquarters

Harleysville, PA, United States

Colorcon Inc. Global Headquarters

Harleysville, PA, United States
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Cifuentes C.,University of Seville | Aguilar-De-Leyva A.,University of Seville | Rajabi-Siahboomi A.R.,Colorcon Inc. Global Headquarters | Caraballo I.,University of Seville
Acta Pharmaceutica | Year: 2013

Percolation theory has been applied to study the drug release behaviour in multicomponent inert matrices containing ethylcellulose as a matrix forming polymer. Global influence of major formulation factors such as polymer viscosity, polymer particle size, drug and filler solubility and porosity of the tablets in drug release kinetics has been studied for the first time. Batches containing three viscosity grades of Ethocel™, microcrystalline cellulose (MCC) and lactose as fillers, a lubricant and flow aid mixture and three drugs with different solubility have been manufactured. For some batches, compression pressure was varied in order to obtain matrices with five levels of initial porosity. The behaviour of inert matrices was explained based on the percolation ranges of the main components of the formulation. The effect of the porosity percolation threshold was observed and the existence of a tricoherent drug-polymer-filler system is hypothesized.


Teckoe J.,Colorcon Inc. Global Headquarters | Mascaro T.,Colorcon Inc. Global Headquarters | Farrell T.P.,Colorcon Inc. Global Headquarters | Rajabi-Siahboomi A.R.,Colorcon Inc. Global Headquarters
AAPS PharmSciTech | Year: 2013

This work describes a quality-by-design (QbD) approach to determine the optimal coating process conditions and robust process operating space for an immediate release aqueous film coating system (Opadry® 200). Critical quality attributes (CQAs) or associated performance indicators of the coated tablets were measured while coating process parameters such as percent solids of the coating dispersion, coating spray rate, inlet air temperature, airflow rate and pan speed were varied, using a design of experiment protocol. The optimized process parameters were then confirmed by independent coating trials. Disintegration time of coated tablets was not affected by the coating process conditions used in this study, while tablet appearance, as determined by measurement of tablet color, coating defects and gloss was determined to be a CQA. Tablet gloss increased when low spray rate and low percent solids were used, as well as with increased coating pan speed. The study used QbD principles and experimental design models to provide a basis to identify ranges of coating process conditions which afford acceptable product quality. High productivity, color uniformity, and very low defect levels were obtained with Opadry 200 even when using a broad range of coating process conditions. © 2013 American Association of Pharmaceutical Scientists.

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