MIRTAZAPINE LOADED PRONANOMICELLES: PREPARATION AND CHARACTERIZATION

Objective: The aim of this work was to prepare mirtazapine-loaded self-assembled micelles using soluplus®, solutol®HS15 and TPGs to enhance mirtazapine solubility and thus oral bioavailability. Methods: MTZ nanomicelles were produced by the thin-film hydration method using different polymers in different ratios to prepare stable MTZ nanomicelles, where the soluplus® nanomicelles formula in different ratios was F1 to F4; soluplus® in combination with TPGS to stabilize the nanomicelles formula was formulated in different ratios as in F5 to F10; and soluplus® in combination with SolutolHS 15 as in F10 to F14. The most stable formula is further investigated with particle size, polydispersity index, drug loading, entrapment efficacy, and in vitro release, and then the selected formula is statistically further investigated with FTIR, DSC, and FESEM. Results: The particle size of the prepared formula ranged from 57 nm for F4 (1:10 of MTZ: soluplus®) to 78 nm for F8 (1:8:4 of MTZ: soluplus®: TPGS); the EE% ranged from 85% to 90%; FTIR analysis suggested no chemical interaction; FESEM showed spherical nanomicelles in Nano size; and DSC showed the transition of the drug to an amorphous form due to MTZ entrapment with in nanomicelles. Conclusion: Mirtazapine-loaded Soluplus® micelles alone and in combination, first with TPGS and second with Solutol HS 15 by the thin-film hydration method show uniform distribution of particle size, PDI, and enhancement in the in vitro release of the drug.