Volume : 12, Issue : 02, February – 2025

Title:

FORMULATION AND EVALUATION OF NEBIVOLOL FAST DISSOLVING TABLETS BY USING DIRECT COMPRESSION METHOD

Authors :

B.Bhagya Sri * , Pranitha Panda

Abstract :

The objective of this research was to develop fast-dissolving tablets of Nebivolol using the direct compression method. Nebivolol hydrochloride is a racemic mixture (dl-Nebivolol hydrochloride) composed of its enantiomers l-Nebivolol hydrochloride and d-Nebivolol hydrochloride. It is a highly selective β1 receptor antagonist with mild vasodilatory properties, potentially due to its interaction with the L-arginine/nitric oxide pathway.
Six formulations (F1–F6) containing 250 mg of Nebivolol were developed using different concentrations of hydrophilic polymers such as PVP K100 and Soluplus, along with excipients including microcrystalline cellulose (MCC), sodium starch glycolate (SSG), mannitol, talc, and magnesium stearate.
The granules were evaluated for pre-compression parameters, and the resulting tablets were assessed for post-compression parameters, including hardness, friability, thickness, weight variation, in-vitro disintegration, and in-vitro dissolution studies.
Among the formulations, F2 was identified as the optimized formulation, demonstrating the fastest drug release profile and best fitting to the first-order kinetic model with an R² value of 0.999. This suggests that F2 ensures rapid drug dissolution, making it a promising candidate for fast-dissolving Nebivolol tablets.
Keywords: Nebivolol Hydrochloride, PVPK100, SOLUPLUS, Microcrystalline Cellulose (MCC), Sodium Starch Glycolate (SSG), Mannitol, Fast Dissolving Tablets, Direct Compression, In-Vitro Dissolution, First-Order Kinetics

Cite This Article:

Please cite this article in press B.Bhagya Sri et al Formulation And Evaluation Of Nebivolol Fast Dissolving Tablets By Using Direct Compression Method.,Indo Am. J. P. Sci, 2025; 12 (02).

Number of Downloads : 10

References:

1. MohdY,Mohd A, Kumar A, Aggarval A. Biopharmaceutical Classification System: an account. International Journal of Pharm Tech Research. 2010; 2(3):1681- 1690.
2. Reddy B.B and Karunakar A. Biopharmaceutics Classification System: A Regulatory Approach. Dissolution Technologies. 2011; (3): 31-37.
3. Chowdary K.P.R, Pavan Kumar A. Recent Research on Formulation Development of BCS class II drugs – A Review. International Research Journal of Pharmacy and Applied Sciences. 2013; 3(1): 173-181.
4. Wagh M.P, Patel J.S. Biopharmaceutical Classification System: Scientific Basis for Bio waiver Extensions. 2010; 2(1):12-19.
5. Rohilla S, Rohilla A, Marwaha R.K, Nanda A. Biopharmaceutical classification System: A Strategic tool for Classifying Drug Substances. International Research Journal of Pharmacy. 2011; 2 (7): 53-59.
6. Brahmankar D.M, Jaiswal S.B. Biopharmaceutics and Pharmacokinetics a Treatise: Second Edition.VallabhPrakashan. 345-347.
7. Patel R.C, Keraliya R, Jansari J, Patel M.M. Application of Biopharmaceutics Classification System in Formulation Development.PH Tech MED.2013; 2(4): 334- 340.
8. WHO Prequalification of Medicines Program; General notes on Bio pharmaceutical Classification System (BCS)- Based biowaiver Applications. Guidance Document: 2011; 1-5.
9. Rohilla S, Rohilla A, Nanda A. Biowaiver criteria and requirements. International Journal of Pharmaceutical & Biological Archives. 2012; 3(4): 727-731.
10. Budhwaar V, Nanda A, The biopharmaceutical classification system (BCS): present status and future prospective. International Research Journal of Pharmacy. 2012; 3(9):7-11.
11. Habib W, Khankari R, and Hontz J. Fast-dissolving drug delivery systems, critical review in therapeutic. Drug Carrier Systems.2000; 17(1):61-72.