Development of microemulsion based system for treatment of central nervous system disorder

Abstract

Materials and Methods: Preformulation study along with drug excipients compatibility study was conducted for OLZ and MZL. UV methods were used for determination of drug content in bulk and from formulation. Drug excipients study was performed for checking suitability of drug with selected excipients. QbD based tools were used to get proper road map for design of microemulsion. Various tools of QbD and DoE were employed for optimization of design. Preliminary study including drug solubility study in various ME components and compatibility study were assessed. Developed formulations ere characterized for various parameters including TEM, globule size, zeta potential, Drug permeation study and other necessary ones. Finally short term stability study was performed for both preparations. Nasal mucosal toxicity study was performed to check the safety of developed MEs. Mucoadhesivity was imparted to develop MEs by adding different mucoadhesive polymers. The mucoadhesive microemulsion (MME) was filled in spray container and finally mucoadhesive microemulsion based nasal spray (MMNS) was developed and it was evaluated for different spray related parameters. newline newlineResults and Discussion: Preformulation study exhibited confirmation of drug. UV methods were successfully developed with desired linearity and were employed further. Drug excipients compatibility study showed stability of drug with proposed excipients. Highest solubility of OLZ and MZM were found respectively in Capryol 90 (oil), Tween 20, Acconon CC6 and Capmul, Tween 80, PEG 400.QbD outline have guided for precise development of formulations. The results of zeta potential, globule size and other parameters proved suitable ME structure for further use. There were no any remarkable signs of toxicity when nasal mucosa was treated by developed MEs. Chitosan at 0.2%w/w concentration was optimized as mucoadhesive polymer which helped to achieve satisfactory sprayability and viscosity. Final MMNs showed desirable spray angle (near 50 degree) and acceptable spray pattern.