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Optimization of process parameters for emulsion solvent evaporation technique in the preparation of nano lipid carriers using definitive screening design
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| Author:
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RAGHAVENDRA REDDY H, SAYANI BHATTACHARYYA, KAVYA H R
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| Abstract:
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The present study focuses on the optimization of process parameters for preparation of nano lipid carriers
(NLC’s) by emulsion solvent evaporation technique. A definitive screening design using JMP 13 was used to analyze
the effect of process parameters on nano lipid carriers. The critical process parameters evaluated were solid lipidliquid
lipid
ratio,
phase
volume
ratio,
surfactant
concentration
and
homogenization
speed.
Each
variable
was
tested
at
two different levels. Thirteen formulations were prepared as per the design. The design was employed to
estimate the effect of each variable on particle size, PDI and surface charge. Model validation was carried out at a
significance level of p<0.05 and the process was optimized at a desirability of 0.90. Three optimized formulations
were prepared in the design space using optimized process parameters. The percentage bias of particle size, PDI
and zeta potential of the predicted and the observed values were found to be less than 5%. The optimized
formulations were subjected for SEM study, which revealed the formation of nano particles. Gas chromatography
of the optimized formulation showed the residual solvent content was within the limit as per ICH Q3 R6
guidelines. The suitability of the process to improve solubility was proved by formulation of nano lipid carriers of
highly lipophilic drugs. Therefore, the design was found to be effective for production of nano lipid carriers by
emulsion solvent evaporation technique.
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| Keyword:
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NLC, Definitive screening design, Optimization, SEM, Gas Chromatography
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| EOI:
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| DOI:
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