Abstract

DEVELOPMENT OF SELF EMULSIFYING DRUG DELIVERY SYSTEM OF NEBIVOLOL FOR THE IMPROVEMENT OF SOLUBILITY AND DISSOLUTION

B. Srinivasa Rao, Ch. Ramanamma and K. A. Chowdary*

Abstract

Nebivolol is a β1-Receptor blocker, used in the treatment of hypertension belongs to BCS class II with poor water solubility. In the present work an attempt has been made to improve the solubility, dissolution by self-emulsifying drug delivery system. Solubility studies are performed by using various oils, surfactants and co surfactants with nebivolol. Micro emulsion region was formed by preparing ternary phase diagram in ratio at 0.15: 0.85 was selected as the selfemulsification region for the development of optimized formulation. Drug excipient interaction studies were performed by using FT-IR. Time of emulsification, freezing and thawing, in vitro dissolution parameters were evaluated. Self-emulsifying drug delivery system of nebivolol was prepared by using oleic acid (oil), Tween 20 Surfactant) and polyethylene glycol 400 ( Co surfactant) and vortex the mixture at 40°C and packed in hard gelatine capsule size of ‘00’. In vitro dissolution was carried out by USP II using 6.8 pH buffer at 75 RPM and absorbance was measured at 281nm using UV Visible spectroscopy. From the studies, the optimized SEDDS was containing 15% of oleic acid, 50% of Tween 20 & 35% of polyethylene glycol 400. The optimized formulation NF5 was showing improve in drug release within 60 minutes and followed by first order drug release mechanism.

Keywords: Nebivolol, SEDDS, Oleicacid, Polyethylene glycol 400.