Desloratadine and pseudoephedrine hydrochloride with different release profiles were prepared in a modified-release multiple unit dosage form (MRMUD). The MRMUD system consisting the immediate-release pellets of desloratadine and sustained release pellets of pseudoephedrine hydrochloride was formulated by using solution layering technique. To optimise the sustained release formulation, a 32 full-factorial configuration was used where the polymer ratio (Ethyl cellulose: hydroxyl propyl methyl cellulose) (X1) and percent polymer coating (X2) were taken as independent variables and the sum of drug release was taken as the dependent variables in 0.1N HCl (Y1) after 10 hrs (Y2). The Design Expert Software was used to carry out optimization studies. For in vitro release studies, formulations were evaluated; the release data was evaluated using the PCP Disso software using the model-dependent (curve fitting) approach. The in vitro drug release followed the Hixson-Crowell model and an anomalous or non-fickian form was found to be the drug release mechanism. Proper combination of ethyl cellulose and hydroxy propyl methyl cellulose polymer, percent polymer coating and process parameters have been found to provide a continuous 12-hour release of pseudoephedrine hydrochloride. The statistical approach to optimization of formulation is a useful tool, particularly when several variables are evaluated simultaneously. The responses observed were in close agreement with the expected values of the optimised formulations, demonstrating the feasibility of the optimization process in the production of the formulation of sustained releases.
Author (s) DetailsMr. Sachin U. Kushare
Department of Pharmaceutics, P. E. Society’s Modern College of Pharmacy, Nigdi, Pune-411 044, Maharashtra, India.
Dr. Atul A. Phatak
Department of Pharmaceutics, P. E. Society’s Modern College of Pharmacy, Nigdi, Pune-411 044, Maharashtra, India.
Dr. Praveen D. Chaudhari
Department of Pharmaceutics, P. E. Society’s Modern College of Pharmacy, Nigdi, Pune-411 044, Maharashtra, India.
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