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Characterization and dissolution profile of inclusion complexes of nifedipine with hydroxy propyl betacyclodextrin and formulation of fast dissolving tablet

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Author(s): Swati C. Jagdale*1, Vinayak N. Jadhav2, Aniruddha R. Chabukswar3, Bhanudas S. Kuchekar4, Pradeep D.Lokhande5

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 8;
Start page: 2764;
Date: 2011;
Original page

Keywords: Fast dissolving tablets | nifedipine | HPBCD | complexation | superdisintegrants | freeze dried complex.

ABSTRACT
Nifedipine is an antianginal drug belonging to a class of pharmacological agents, the calcium channel blockers. One of the major problems with the drug is that, it is practically insoluble in water, which results in poor bioavailability after oral administration. Hydroxypropyl betacyclodextrin improve the solubility & dissolution rate of nifedipine via complexation. The stoichiometric ratio determined by phase solubility analysis for inclusion complexation of nifedipine with hydroxypropyl betacyclodextrin was 1:1 with stability constant 268.93 M-1. The negative nature of the Gibbs free energy changes (?Gtr°) are indicative of the spontaneity of the process. Binary complexes were prepared by using different methods and were further characterized using UV, XRD, DSC, FT-IR. Saturation solubility study was carried out to evaluate the increase in the solubility of nifedipine. In vitro release study of nifedipine from inclusion complexes was carried out to see the effect of binary complexation on drug release. Freeze dried complex showed maximum increase in the solubility (38.43 μg/ ml) of drug as compared toother complexes and at the same time showed no limiting effect on the drug release. In the present study an attempt has been made to prepare fast dissolving tablets of nifedipine using drug-hydroxypropyl betacyclodextrin complex and superdisintegrants such as Doshion P544, pregelatinized starch, crosspovidone, sodiumstarch glycolate and croscarmellose sodium by direct compression. Tablets were evaluated for the hardness, friability, assay, thickness, disintegration time and average weight. Tablets shows enhance dissolution rate as compared to pure nifedipine.
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