Nifedipine, a calcium channel blocker antihypertensive drug, is a poorly water soluble drug and belongs to BCS class II. The objective of the research work was to formulate and optimize solid dispersions (SDs) of a poorly water soluble drug, nifedipine, with sodium starch glycollate, croscarmellose sodium, eudragit E-100. Solid dispersions were prepared by solvent evaporation techniques in different weight ratios of polymers. The results indicated that homogeneous or heterogeneous conditions during the preparation methods employed governed the internal structures of the polymer matrices while retaining the drug in an amorphous form. The physical mixtures and solid dispersions were subjected to drug content and dissolution test. The best formulation, nifedipine with croscarmellose sodium in 1:7 ratio, among all was further adsorbed on neusilin US2 to form ternary mixture. The increased dissolution was achieved by more than 70percent and 30percent comparatively to the nifedipine API and marketed product respectively. The tablet dosage form prepared from ternary mixture was stable at stressed conditions 40±2°C and 75±5% RH. The release kinetics of drug from formulation and marketed product follows peppas model. The similar factor f2 was within limit for the product at stressed conditions with the product at room temperature at the same time.
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*Corresponding Author Address: Dr. Mahesh Kumar Kataria, Department of Pharmaceutics, Seth G.L. Bihani S.D. College of Technical
Figure 8: Nifedipine standard calibration curve in hydrochloric acid buffer pH 1.2 at λmax 236nm
Figure 9: Dissolution profile of formulation Ternary mixture and its comparison to pure nifedipine API,
marketed product and SD8
Figure 10: DSC Thermogram of Nifedipine API
Kataria et al., World J Pharm Sci 2014; 2(3): 224-236
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Figure 11: DSC Thermogram of Nifedipine Ternary Mixture
Figure 12: Dissolution profile of nifedipine tablet formulated, ternary mixture and its comparison to pure
nifedipine API, marketed product and SD8
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