Display options
Cite
Shaikh SA, Shaikh SS, Shahi SR, et al. Formulation and evaluation of s-(-)-amlodipine besylate and nebivolol hydrochloride tablets. J Adv Pharm Technol Res. 2010;1(2):199-206
Shaikh, S. A., Shaikh, S. S., Shahi, S. R., Shookur, M. A., Reddy, L. K., Padalkar, A. N., & Thube, M. (2010). Formulation and evaluation of s-(-)-amlodipine besylate and nebivolol hydrochloride tablets. Journal of advanced pharmaceutical technology & research, 1(2), 199-206.
Shaikh, S A, et al. "Formulation and evaluation of s-(-)-amlodipine besylate and nebivolol hydrochloride tablets." Journal of advanced pharmaceutical technology & research vol. 1,2 (2010): 199-206.
Shaikh SA, Shaikh SS, Shahi SR, Shookur MA, Reddy LK, Padalkar AN, Thube M. Formulation and evaluation of s-(-)-amlodipine besylate and nebivolol hydrochloride tablets. J Adv Pharm Technol Res. 2010 Apr;1(2):199-206. PMID: 22247846; PMCID: PMC3255425.
Copy Download .nbib Format: NLM
Share it on

J Adv Pharm Technol Res. 2010 Apr;1(2):199-206.

Formulation and evaluation of s-(-)-amlodipine besylate and nebivolol hydrochloride tablets.

Journal of advanced pharmaceutical technology & research

S A Shaikh, S S Shaikh, S R Shahi, M A Shookur, L K Reddy, A N Padalkar, Mahesh Thube

Affiliations

  1. Jeevanjyoti Pharmaceutical, Aurangabad, Maharastra, India.

PMID: 22247846 PMCID: PMC3255425

Abstract

The objective of the present study was to develop a tablet formulation of S-(-)-amlodipine besylate chiral separation drug and nebivolol hydrochloride for better management of hypertension, while reducing or avoiding undesirable adverse effects, which are often associated with administration of a racemic mixture of amlodipine. The composition containing the optically pure S-(-)- isomer of amlodipine 2.5 mg has calcium channel blocking activity and, nebivolol hydrochloride 5 mg has beta-receptor blocking activity.The study was also carried out to design a suitable dissolution medium for S-(-) - amlodipine besylate and nebivolol hydrochloride. Amlodipine besylate and nebivolol hydrochloride had maximum solubility in pH 1.2 and thus pH 1.2 was selected as the most suitable media for S-(-) - amlodipine besylate and nebivolol hydrochloride dissolution studies. The RSD below 2% indicated insignificant batch-to-batch variation. The accelerated stability study of the optimized formulation was performed as the ICH guidelines. The results indicated no change in optical rotation of S-(-) - amlodipine besylate. Hence, combination of two drugs can be formulated into the tablet by wet granulation technique having satisfactory release profile.

Keywords: S-(-) - amlodipine besylate; Tablet; combination therapy; dissolution; nebivolol hydrochloride; wet granulation

References

  1. Am J Ther. 2003 Jan-Feb;10(1):29-31 - PubMed
  2. J Chromatogr B Biomed Sci Appl. 1997 Dec 5;703(1-2):185-93 - PubMed
  3. J Chromatogr B Biomed Sci Appl. 1997 Jun 6;693(2):367-75 - PubMed
  4. Chirality. 1994;6(7):531-6 - PubMed
  5. JAMA. 2002 Oct 16;288(15):1882-8 - PubMed
  6. Clin Pharmacokinet. 1992 Jan;22(1):22-31 - PubMed

Publication Types