Solubility Enhancement of Brexpiprazole for Schizophrenia using HPβ Cyclodextrin Ternary Complexation

Introduction: The present study focuses on the solubility and dissolution rate enhancement of Brexpiprazole with Hydroxy Propyl β-cyclodextrin and succinic acid as a solubiliser for schizophrenia. Materials & Method: Brexpiprazole was obtained as a gift sample from CTX Life sciences, Sachin, Surat. Hydroxypropyl beta cyclodextrin was gifted by Good Health Pvt. Ltd Sachin, Surat. Binary and ternary complexes were prepared using three different methods and characterized using the fourier transform infrared spectroscopy, differential scanning calorimetry, X-ray diffraction and invitro dissolution studies. Results: It was observed that among different ratios of drug and polymer used, 1:5 ratio of drug and polymer for binary complex was found to be the optimized and solvent evaporation method gave the best results. The ternary complex was then prepared using this ratio in different concentration of succinic acid (0.25, 0.5 and 1 % w/w) and optimum concentration of succinic acid as a solubiliser was of 1 %. The drug release was found to be maximum 92 % as compared to binary complex. The fourier transform infrared spectroscopy, differential scanning calorimetry and X-ray diffraction results confirmed the formation of stable complex. Conclusions: It was concluded that ternary complex had maximum drug release of 92% at the end of 60 minutes resulting in solubility and dissolution rate enhancement.