World Journal of
Pharmaceutical and Life Sciences

DESIGN AND EVALUATION OF NEBIVOLOL HCl IN THE TREATMENT OF HYPERTENSION

K. R. Hemalatha*, V. Kalvimoorthi, L. Gopi, A. Haripriya and M. Eshvandhini

ABSTRACT

This study focuses on the formulation and evaluation of a fixed-dose combination tablet of Nebivolol HCL for the effective management of hypertension. The tablet contains 2.5 mg of Nebivolol HCL as an immediate-release component. The pre-compression parameters of the powder blends used for the formulation were within pharmacopeial specifications, demonstrating good flow and compressibility. A novel formulation utilizing Croscarmellose sodium for the immediate-release layer was developed using the direct compression technique. Excipients were selected based on favorable drug-excipient compatibility results. The highest in-vitro release of Nebivolol HCL was 85.37% within 30 minutes, and the F1 formulation was selected for tablet preparation. The fixed-dose tablet of Nebivolol HCL aims to improve patient compliance by enhancing dosing frequency and bioavailability. Dissolution and stability studies conducted in accordance with ICH guidelines showed promising results within the initial two months, with further studies ongoing. Upon successful completion of stability studies, bioequivalence testing will be performed. If successful, the developed product could be introduced to the market for improved hypertension management.

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