PubMed · 7752783
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W R Herzog. 1995-05-27. ISIS-4.. https://pubmed.ncbi.nlm.nih.gov/7752783/
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The purpose of this study is to characterize the nature and solid-state properties of a solid dispersion system of nifedipine (33.3% w/w) in a polymer matrix consisting of Pluronic F68 (33.3% w/w) and Gelucire 50/13 (33.3% w/w). The nature of nifedipine dispersed in the matrix was studied by powder X-ray diffractometry (PXRD), differential scanning calorimetry (DSC) and diffuse reflectance infrared Fourier transform spectroscopy (DRIFTS). The rate and extent of water uptake of the solid dispersion were determined by weight gain. The dissolution rate of nifedipine solid dispersion was determined using Apparatus 2 of USP XXIII (1995). Quantitative PXRD showed that the saturation solubility of nifedipine in the polymer matrix is 2.1-3.0% w/w and indicated an excess of crystalline nifedipine in the solid dispersion. The maximum water uptake by the solid dispersion exposed to 75% RH at 45 degrees C was 3.3 times higher than for the dispersion exposed to 65% RH at 25 degrees C. Over 8 weeks, PXRD and DRIFTS of the nifedipine matrix stored at 25 or 4 degrees C were unchanged, showing constancy of crystallinity and intermolecular interactions. For a given mass of nifedipine (20 mg) and for a given particle size of nifedipine (<850 microm), the initial release rate of nifedipine from the solid dispersion was faster (46.2% of the nifedipine dissolved in 20 min) than that of the pure drug (1.2% of the nifedipine dissolved in 20 min). The results indicate that the nifedipine solid dispersion is physically stable over 8 weeks. Nifedipine is released faster from the solid dispersion than from the pure crystalline drug of the same particle size.
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A stability indicating reversed-phase liquid chromatographic (RP-LC) method was developed for the assay of felodipine as a bulk drug and in pharmaceuticals. The chromatography was performed on a C18 column. Eluents were monitored by UV detection at 238 nm using the mobile phase methanol-potassium dihydrogen orthophosphate (pH 3.5; 0.01 M) (75:25, v/v). The method was statistically validated for linearity, accuracy, precision and specificity. The linearity of felodipine peak area responses was demonstrated within the concentration range of 1-7 microg/ml. The limits of detection and quantitation were 150 and 500 ng/ml, respectively. The method was demonstrated to be precise, accurate and specific with no interference from the tablet excipients and separation of the drug peak from the peaks of the degradation products (oxidative degradation, photodegradation, acid and base degradation). The results indicated that the proposed method could be used in a stability assay.