Abstract

Demonstration of Multivariate Data Analysis for the QbD based Systematic Development of Nanoemulsions containing Boswellia serratta with Enhanced Topical Delivery.

Asha Patel, Associate Professor, Parul University

The chemometric techniques have been used to demonstrate the role of nanoemulsion components on release of Boswellic acids. In current study, systematic development, optimization and evaluation (in vitro, ex vivo and in vivo) of the nano formulations employing rational quality by design (QbD)-based approach through multivariate data techniques for formulation design. The safe, effective and quality target product profile (QTPP) and critical quality attributes (CQAs) were highlithtened during preliminary scrrening of components. Nanoemulsions were screened initially through risk assessment by determining the solubility of boswellic acids in various systems, compatibity with excipients. Simplex lattice mixture design was applied to optimize the percentual composition of nanoemulsions. The Permeability coefficient and droplet size were modelled with set of variables by partial least squares (PLS). Partial least square regression analysis was done through Excel STAT to influence mixture composition on permeation behavior of drug from the nanoemulsion. The spherical droplet shape was confirmed by TEM analysis. Physicochemically stable and non-irritant formulation was developed to deliver significant amounts of boswellic acids through skin showed significant percentage inhibition in rat paw edema. Present study illustrated QbD based development of nanoemulsion with scientific and statistical evidence as possible alternative to traditional topical formulations.