Evaluation of a Rapidly Disintegrating, Moisture Resistant Lacquer Film Coating

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Abstract
Simplex optimization was used during the development of a rapidly disintegrating, moisture resistant lacquer film coating. A hygroscopic aniomic exchange resin with the capability of adsorbing four to five times its weight in water was used as the model drug. The coating variables investigated included levels of magenesium stearate, talc, hydroxypropylmethylcelluslose (5 cps), polyethylene glycol 8000, Opaspray, and Eudragit E30D. Response parameters monitored included disintegration time, percent weight gain after 48 hours in a 30 deg C 75% relative humidity chamber and physical appearance. The effect of the core tablet on the performance of the coated tablet was also investigated. This study illustrates the use of the simplex design in the development of a film coating formula. It also examines the interaction between the core tablet and the film coating.

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