Preparing sustained release dosage forms of nifedipine by hot-melt coating method Public Deposited

http://ir.library.oregonstate.edu/concern/graduate_thesis_or_dissertations/4b29b801x

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  • Preparing sustained release dosage form of nifedipine by hot-melt coating method
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  • A nifedipine sustained release dosage form was prepared by using hot-melt batch coating. Substrates are sugar beads, mesh size 30-35. Stearic acid, Acid Triglyceride, and carnauba wax were coating agents used to make single layer coated beads and multiple layer coated beads containing nifedipine. Dissolution of nifedipine from the beads and from capsules containing the beads was evaluated for 24 hours. Goodness of fit, total drug released, and "acceptance value" according to the "Acceptance Table" in USP25- NF2O were criteria used to evaluate dissolution profile in vitro. Convolution process was applied to obtain predicted plasma concentrations for comparison to published data for two well known commercial products: Adalat® CC and Procardia® XL 30mg. In vitro test results showed the new hot-melt batch coating process is feasible to produce zero-order kinetics for drug dissolution. Capsules containing dual coated beads with carnauba wax in the inner coating layer and stearic acid in the outmost layer yielded similar dissolution profiles and predicted plasma concentrations to Procardia XL. However, drug quantity deposited on the sugar bead was low, thus it is necessary in the future to alter formulation to improve drug loading capacity.
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