Formulation and Evaluation of Immediate Release Bilayer Tablets of Telmisartan and Hydrochlorothiazide

DOI:

https://doi.org/10.37285/ijpsn.2011.4.3.6

Authors

  • Natarajan R
  • N Patel
  • Rajendran N N
  • M Rangapriya

Abstract

The main goal of this study was to develop a stable formulation of antihypertensive drugs telmisartan and hydrochlorothiazide as an immediate-release bilayer tablet and to evaluate the dissolution profile in comparison with a reference product. The formulation development work was initiated with wet granulation. Telmisartan was converted to its sodium salt by dissolving in aqueous solution of sodium hydroxide to improve solubility and drug release. Lactose monohydrate and microcrystalline cellulose were used as diluents. Starch paste is prepared in purified water and was used as the binder. Sodium starch glycolate is added as a disintegrating agent. Magnesium stearate was used as the lubricant. The prepared granules were compressed into a double-layer compression machine. The tablets thus formulated with higher proportion of sodium starch glycolate showed satisfactory physical parameters, and it was found to be stable and in vitro release studies are showed that formulation (F-T5H5) was 101.11% and 99.89% respectively. The formulation T5H5 is further selected and compared with the release profile of the innovator product, and was found to be similar (f2 factor) to that of the marketed product. The results suggest the feasibility of developing bilayer tablets consisting of telmisartan and hydrochlorothiazide for the convenience of patients with hypertension.

 

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Keywords:

Bi-layer tablets, telmisartan, hydrochlorothiazide, super disintegrant.

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Published

2011-11-30

How to Cite

1.
R N, Patel N, N N R, Rangapriya M. Formulation and Evaluation of Immediate Release Bilayer Tablets of Telmisartan and Hydrochlorothiazide. Scopus Indexed [Internet]. 2011 Nov. 30 [cited 2024 May 18];4(3):1477-83. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/440

Issue

Vol. 4 No. 3 (2011): October-December 2011

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

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