Abstract

DESIGN, FORMULATION AND EVALUATION OF DONEPEZIL HCL FILM COATED TABLET

Swati S. Rawat* and Amol Madane

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Abstract

Among the advancement in the field of solid drug delivery system, tablets are the most important solid dosage forms for the delivery of drugs to the patients. The film-coating process involves spraying of a coating solution onto a tablet bed in pan coater followed by immediate drying to form a thin, even film on the tablet surface. Usually, three main methods of coating are used, i.e., modified conventional coating pans, fluid bed equipment, and side-vented pans. Film formation and coating uniformity can be influenced by the following process parameters: method of atomization of the coating suspension, method of moving the tablet bed that ensures that all tablets are sufficiently mixed and agitated, and finally, adequate heat input to provide rapid drying of the applied coat. In addition to process parameters, tablet properties (e.g., size, shape, porosity, hardness, density, pan loading, etc.), as well as equipment specific parameters (e.g., pan diameter, geometry, baffle configuration, etc.) all significantly impact the coating quality. Donepezil Hydrochloride tablets were formulated by using the following formula, mixing of drug, polymers and other ingredients, drying, dry granulation, sifting & milling, Blending was done as per regular procedure before compression and then were film coated. Compression force for all the tablets was adjusted to get tablets of hardness 3.5- 6 kg/cm2. Weight of tablets was adjusted to 140 mg for uncoated and to 144.2 mg for coated. Risk management is done by identification, evaluation, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities. During the formulation, compression and coating various risk were identified and minimized them to reduce the various hazards.

Keywords: Donepezil Hydrochloride, film coating, risk management, risk identification, risk control, risk monitoring and risk minimization.