Abstract

FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS OF NEBIVOLOL HYDROCHLORIDE

B. Dharshini Swapna* and N. Ashok

ABSTRACT

Nebivolol is a β-1 receptor blocker with nitric oxide-potentiating vasodilatory effect used in treatment of Hypertension and also for left ventricular failure Nebivolol has half-life about 10 hrs. In hypertension the initial dose of Nebivolol is 5mg once daily and maximum dose is 40mg once daily. Nebivolol is poorly soluble in water hence the basic objective of this study was to produce immediate release Nebivolol tablets containing super disintegrants via Direct compression, to improve disintegration, dissolution and to get faster onset of action. Super disintigrants used in this formulation are Microcrystalline cellulose and Cross carmellose sodium, Sodium starch glycolate. The drug-excipients interaction was investigated by FT- IR. Tablets were subjected to physicochemical characterization such as thickness, weight uniformity, drug content, in vitro drug release, and stability studies. Tablets were found to be satisfactory when evaluated for thickness, weight uniformity, invitro drug release, drug content and disintegration time. The in vitro drug release for optimized formulation F12 was found to be 98 % in 40 min. The optimized formulation F12 (8% CCS) also showed satisfactory drug content (99.68%), disintegration time of 34 seconds and satisfactory stability. The optimized formulation (F12) is further selected and compared with the in-vitro release profile of the innovator product.

Keywords: Nebivolol, ?-1blocker, immediate release tablet, super disintegrants, Cross carmellose sodium.