The objective of the present work was to formulate a self-emulsifying drug delivery system (SEDDS) for simvastatin, which is widely used in the treatment of hypercholesterolemia and dyslipidemia as an adjunct to diet. Simvastatin SEDDS were formulated using a 1:1 (V/V) mixture of diesters of caprylic/capric acids and polyglycolyzed glycerides with varying concentrations of polyoxy castor oil and C8/C10 mono-/diglycerides. The developed SEDDS were evaluated for turbidimetry, droplet size analysis, drug content and in vitro diffusion profiles. In vivo performance of the optimized formulation was evaluated in rats using pharmacodynamic marker parameters like plasma total cholesterol (CH), triglycerides (TG) and high-density lipoprotein (HDL-CH) for 21 days. SEDDS containing 9.1% (m/m) simvastatin and 23.0% (m/m) of each excipient showed minimum mean droplet size (124 nm) and optimal drug diffusion. This test formulation showed significant reduction in plasma CH and TG (around 5-fold and 4-fold, respectively), while HDL-CH concentration was markedly higher (2-fold) compared a reference simvastatin suspension formulation after oral administration for 21 days of study. Test formulation has shown enhanced pharmacodynamic performance compared to reference formulation in rats. The study illustrated the potential of simvastatin SEDDS for oral administration and its biopharmaceutic performance.
This paper presents the development and validation of high performance thin layer chromatography (HPTLC) with a densiotometric detection method for the simultaneous analysis of Gliclazide and Metformin hydrochloride. A separation was performed on silica gel 60F254 plates. The mobile phase comprised of toluene, acetonitrile, ethanol, Ammonium sulphate (0.25%) (4 : 4 : 4 : 3, v/v/v/v). The detection of wavelength was found to be 228nm. The Rf values of GLZ and MET were found to be 0.69 and 0.37 respectively. The accuracy and reliability of the method was assessed by evaluation of linearity 200-1000ng per spot of GLZ and MET. Precision intra-day and inter-day RSD values were always less than accuracy (97.37 for GLZ and 94.8 for MET) specificity in accordance with ICH guidelines. The developed HPTLC method was found to be new, accurate and precise.
Asava and Arishta are alcoholic medicaments prepared by allowing the herbal juices or their decoctions to undergo fermentation with the addition of sugar. Standardization of ayurvedic formulation is important so as to assess the standard of medication. Within the present study standardization of asava from fruit tree Carica papaya, known to be effective in Dengue fever, Cancer cell growth inhibition, Antimalarial has been performed. Asava formulation was prepared by the normal method of Ayurveda. The formulation has been standardized by modern scientific control procedures for the finished products. Standardization of asava was achieved by organoleptic study, physicochemical parameters like PH, denseness, total solid content, amount, alcohol content, index of refraction, total reducing sugars, and stability study. The results have revealed that the physicochemical parameters were within the bounds and also the values may be wont to establish and formulate procedures for standardization and quality controlling of those ayurvedic formulations.
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