Development and Evaluation of Lidocaine Hydrochloride Cubosomes directed by QbD

: Cubosomes, which are modified cubic phase systems, are looking very promising as a method of delivering both hydrophilic and lipophilic drugs. Transdermal delivery of cubosomes is currently gaining more importance over conventional topical delivery of drugs. The proposed study aimed to produce Lidocaine hydrochloride loaded cubosomes. This study was designed to prepare various formulations of Lidocaine nano cubsomal dispersions at different concentrations of lipid and stabilizer using optimization technique. For the purpose of prolonging the duration of the local anaesthetic action, Lidocaine-loaded cubosomes were developed by bottom up method utilizing Glyceryl mono oleate and Poloxamer 407 in various ratios using the "Quality by Design" approach, 3 2 factorial design employing statistical software. Within the confidence intervals, the 3 2 statistical design was effective at forecasting the optimized formulation's composition. Surface morphology, particle size, drug content, poly dispersibility index, zeta potential, entrapment efficiency, and in vitro drug release studies were conducted on the prepared formulations. Several mathematical models were used to conduct and assess an in vitro drug release investigation. The maximal entrapment efficiency for the LH8 formulation, which was validated to have optimum cubosomes dispersion, was reported to be 78 % with vesicle size as 150 nm, Zeta potential 21.5 mV and Poly Dispersibility Index as 0.08 along with an in vitro drug release 80.03 % by the end of 24 hours. A stable dispersion with appreciable results of evaluation parameters of cubosomal dispersion was conferred with formulation LH8. Hence from amongst the nine formulations developed, it is concluded that LH8 is selected as the optimized dispersion to be incorporated into a gel formulation.