FORMULATION AND CHARACTERIZATION OF GRISEOFULVIN LOADED LIPOSOMES USING QUALITY BY DESIGN (QBD) APPROACH
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Keywords
QbD, optimization liposome, antifungal, griseofulvin
Abstract
The objective of the present investigation was to formulate liposomes of griseofulvin using quality by design (QbD) approach and evaluate the formulation for various parameters. A D-optimal experiment design with two independent and two dependent variables was used to optimize the formulation with the best QTPP. Phospholipid concentration, phospholipid to stearyl alcohol molar ratio were selected as the critical parameters affecting the desired CQAs. The effect of phospholipid concentration and the ratio of phospholipid to stearyl alcohol was statistically validated using ANOVA and the 2 factorial model depicted a significant F-value of 35.83 for entrapment efficiency. The model presented a regression coefficient value of 0.9896 and adequate precision value of 17.274. The particles of the optimized liposome were found to be having an average particle size of 149.1 nm with a poly dispersity index of 0.428 and a zeta potential of -17.1 mV. The entrapment efficiency was found to be 72.71 ± 1.047 % (n=3). The in vitro release showed that the optimal liposomal formulation released only 74.78 ± 1.8680 % griseofulvin after 72 h. The formulation was subjected to stability analysis for 28 days and the amount of griseofulvin retained in the formulation was considered as the stability indicator. It was seen that around 3.08% drug was lost in the 28 days of keeping the formulation.
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Indra Kumar
Radharaman Institute of Pharmaceutical Sciences, Bhopal
Kapil Malviya
Radharaman Institute of Pharmaceutical Sciences, Bhopal
Pushpendra Soni
Radharaman Institute of Pharmaceutical Sciences, Bhopal
Pushpendra Kumar
Radharaman Institute of Pharmaceutical Sciences, Bhopal
Lavakesh Kumar Omray
Radharaman Institute of Pharmaceutical Sciences, Bhopal