Design and Development of Microemulsion Based Transdermal Gel of Lercanidipine Hydrochloride by Assimilation of Rotatable Central Composite Design and Principal Component Analysis

The objective of the present research was to design and develop microemulsion (ME) based transdermal systems of poorly water soluble drug, Lercanidipine hydrochloride (LDPH) by assimilation of central composite design and principal component analysis (PCA) as two important paradigms of quality by design. LDPH loaded O/W MEs were optimized with amounts of oil (Capryol 90), surfactants mixture (Cremophor EL and Ethanol) and water as independent variables along with cumulative amount of drug permeated in 24 h (Q24), flux (Jss) and lag time (tL) as dependent variables. The optimized batch of LDPH loaded ME was successfully converted into microemulsion based gel (MBG) for increased patient compliance. The results of in vitro skin permeation of the optimized batch of LDPH loaded MBG revealed significant increase in permeability parameters as compared to its convention formulation. The values of Jss for optimized batch of LDPH loaded MBGs (196.47 μg/cm2h) revealed 7.95 cm2 area requirement to obtain the desired input rate of LDPH within 24 h application. All these concluded suitability of experimental design and PCA for design and development of O/W type MEs as carriers for transdermal delivery of poorly water soluble drug, LDPH.