FORMULATION AND INVITRO/ INVIVO EVALUATION OF DRIED NANOSUSPENSIONS OF NEBIVOLOL

In the present study, an attempt was made to prepare oral Nanosuspension of Nebivolol (a beta1 blocker), in order increase drug solubility and to overcome bioavailability problems, to reduce dose dependent side effects and frequency of administration. Nanosuspension containing the drug was prepared by precipitation method using combinations of polymers (such as tween 80, tween 20, soluplus, PEG 200, PEG 400 and methanol) in to 12 formulations F1to F12. Subsequent drying was done by spray drying method to form dried nanosuspensions. The Nanosuspensions were evaluated for particle size, zeta potential, drug content uniformity, in-vitro drug release, short-term stability, and drug- excipient interactions (FTIR). IR spectroscopic studies indicated that there are no drug-excipient interactions. The formulation F10 containing Tween 80, Tween 20, Soluplus, PEG 200, PG, Methanol and water were found to be promising, which showed 100% drug release within 15 min when compared to the optimised formulation (Bystolic) which showed only 91.95% drug release for 20mins. SEM (scanning Electron Microscopy) analysis showed average particle size to be at 300.3nm and it also shown desired zetapotential value. Short-term stability studies indicated stability with respect to drug content and dissolution. Dried Nanosuspension of nebivolol can be prepared by precipitation method and spray drying was done. Among all the formulations, F10 was found to be promising with 100% drug release in 15mins. Short-term stability studies of the promising formulation indicated that there are no significant changes in dissolution parameter values after 3 months.