Ketoconazole Quality: A Case Study
6.3 RESULT & DISCUSSION: The stability of formulated product was evaluated by sorting at various temperature 40C, 250C, and 450C. They were evaluated in every 15 days for 45 days. The formulation was checked for both physical stability and drug release. No any change in its color, pH, consistency, phase separation, homogeneity and viscosity within the storage of 45 days. However on storing the formulated product at 450C color, pH, consistency, phase separation and viscosity changes were observed which might be due to degradation of the gel at high temperature. The residual drug content of formulated product for 45 days in 15 days after storing at 40C it was found to be 96.5±0.018, whereas at room temperature and at 45oC it was found to be 95.3±0.35 and 82.1±0.01 respectively. Thus, we can finally conclude …show more content…
The pH value of the optimized formulation was found to be 6.8 which were near the ph value of the skin, so it does not give any adverse effect. The pH value of formulation was found to be suitable for topical delivery The values of spreadability indicate that the Ketoconazole loaded NLC gel is easily spreadable by small amount of shear. Spreadability of formulated product was found to be 18.97±0.75 g.cm/sec, which indicates spreadability of formulated product was good. In vitro drug release studies of the formulated NLC and NLC gel was determined by using egg membrane in PBS pH 7.4. The % drug release from the formulated product was found to be 94.89±0.55 and 87.29±0.49 respectively. This shows that the formulated product having a sustain release of the medicament. Ex vivo drug release studies of the formulated NLC gel was determined by using rat skin in PBS pH 7.4. The % drug release from the formulated product was found to be 82.52±0.48. This shows that the formulated product having a sustain release of the
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