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Preformulation Studies of Nifedipine
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| Author:
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J. SRINIVASARAO
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| Abstract:
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The preformulation studies deals with physical; chemical properties of Nifedipine for the generation of bi-layer heterogeneous tablets formulation development studies. Solubility studies for saturated solutions were carried out over the pH range of 1.2-6.8. The solubility of Nifedipine in water at 37°C was 436.3mg/L. Further the solubility is not affected significantly (P < 0.05) in the buffer solutions in a pH range of 1.2 to 6.8. The PSD histograms represents the presence of Dv (50) 7.18µm; Dv (90) 19.3µm µm particles of Nifedipine. From the p-XRD studies; the diffraction line profiles are 2? values for diffraction peaks at 11.7504°, 11.9178°, 12.9763° confirms to form D for Nifedipine. By the UV-Visible; FTIR; NMR and Mass spectroscopy studies Characterized to Nifedipine. The DSC thermo gram conforms to of Nifedipine at 172.77°C. The Assay content results of three APIs were within 99%-101%. The Nifedipine contains nitro phenyl pyridine, nitroso phenyl pyridine analogues, and methyl 3-amino but-2-enoate is <0.1% with >99.9% purity and all other unknown impurities were not detected in the drug substance. The compatibility of binary mixtures of drug and excipients, stored at 40°C ± 2°C/ 75% ± 5% RH for 1 month was assessed and the % results of Assay and impurities from initial period to after 30th day not have significant difference; P<0.01. The preformulation results conforms, the Excipients PVP K-30; Croscarmellose Sodium; HPMC K-15/E-5, Carbomer 974p, Ethyl cellulose, Xanthan gum, ZnO, and SiO2 were compatible with Nifedipine and selected for development of control release bilayer tablets.
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| Keyword:
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Preformulation studies; DSC studies; NMR Studies; FTIR Studies; p-XRD studies
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2020.12.03.011
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| Download:
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