Abstract

FORMULATION AND OPTIMIZATION OF SELF NANOEMULSIFYING DRUG DELIVERY SYSTEMS OF CARIPRAZINE

Rajnikant Suthar, Ajay Solanki*, Rajesh Palva, Prajesh Prajapati, Umang Shah, Krunal Detholia

ABSTRACT

This study aimed to develop a self-nanoemulsifying drug delivery system (SNEDDS) to enhance the dissolution rate of Cariprazine Hydrochloride (CPH). Excipients were selected through equilibrium solubility studies and pseudo-ternary phase diagram analysis. The formulation was optimized using central composite design (CCD) with two independent variables: oil (X1) and Smix (X2) concentrations. The formulation was evaluated for self-emulsification time (Y1), mean globule size (Y2), and percentage transmittance (Y3). The optimized liquid SNEDDS (L-SNEDDS) underwent assessment for robustness to dilution, thermodynamic stability, TEM analysis, zeta potential measurement and in-vitro drug release study. The optimized L-SNEDDS formulation, comprising 30% oil and 70% surfactant mixture (Smix) exhibited robust performance and thermodynamic stability suitable for oral administration. TEM analysis confirmed uniform spherical nanoglobules. Zeta potential of optimized batch was found to be -28.2 mV exhibited that prepared formulation was electokinetically stable. Drug release study achieved rapid dissolution (98.42% drug release in 30 min) and maintained its physicochemical stability throughout the evaluation period. This study demonstrates that L-SNEDDS technology effectively enhances the solubility, increase rate of dissolution of CPH.

Keywords: Cariprazine, SNEDDS, Pesudo-ternary phase diagram, Central composite design, Dissolution.