Response surface methodology for optimization and characterization of limonene-based coenzyme Q10 self-nanoemulsified capsule dosage form

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Abstract
The aim of this study was to systematically obtain a model of factors that would yield an optimized self-nanoemulsified capsule dosage form (SNCDF) of a highly lipophilic model compound, Coenzyme Q10 (CoQ). Independent variables such as amount of R-(+)-limonene (X 1), surfactant (X 2), and cosurfactant (X 3), were optimized using a 3-factor, 3-level Box-Behnken statistical design. The dependent variables selected were cumulative percentage of drug released after 5 minutes (Y 1) with constraints on drug release in 15 minutes (Y 2), turbidity (Y 3), particle size (Y 4), and zeta potential (Y 5). A mathematical relationship obtained,Y 1=78.503+6.058X 1 +13.738X 2+5.986X 3−25.831X 1 2 +9.12X 1X2−26.03X 1X3−38.67X 2 2 +11.02X 2X3−15.55X 3 3 (r 2=0.97), explained the main and quadratic effects, and the interaction of factors that affected the drug release. Response surface methodology (RSM) predicted the levels of factorsX 1,X 2, andX 3 (0.0344, 0.216, and 0.240, respectively), for a maximized response ofY 1 with constraints of >90% release onY 2. The observed and predicted values ofY 1 were in close agreement. In conclusion, the Box-Behnken experimental design allowed us to obtain SNCDF with rapid (>90%) drug release within 5 minutes with desirable properties of low turbidity and particle size.