Abstract
The present study involves the formulation and characterization of valsartan (VT) oral disintegrating tablets by using crospovidone (CP) and Hibiscus rosasinensis (HRS) mucilage as complexing agent. Valsartan (VT), anti-hypertensive drug (class II) is an orally active non-peptide triazole-derived antagonist of angiotensin II. The direct compression method was used to obtain 13 such formulations, and the tablets obtained were evaluated for drug content, hardness, friability (FT), disintegration time (DT) and dissolution rate. A significant increase in the dissolution rate of VT was obtained. FTIR and DSC studies showed no interaction between the drug and excipients. The amount of CP (X<sub>1</sub>) and amount to HRS mucilage (X<sub>2</sub>) is selected for 3<sup>2</sup> factorial designs. The DT (Y<sub>1</sub>), FT (Y<sub>2</sub>) and % drug released at 25 min (Y<sub>3</sub>) interval were taken as the response variables. X<sub>1</sub> and X<sub>2</sub> represents the result of changing the variable at a time from low level to high level. The interaction terms (X<sub>1</sub>X<sub>2</sub>, X<sub>1</sub><sup>2</sup>, X<sub>2</sub><sup>2</sup>, X<sub>1</sub><sup>2</sup>X<sub>2</sub> and X<sub>1</sub>X<sub>2</sub><sup>2</sup>) exhibited that Y<sub>1</sub>, Y<sub>2</sub> and Y<sub>3</sub> had changed simultaneously (as analyzed by Design expert software 8 version). The contour and 3D plots revealed that there is an effect of X<sub>1</sub> and X<sub>2</sub> with the interaction on Y<sub>1</sub>, Y<sub>2</sub> and Y<sub>3</sub>. F<sub>2</sub> formulation exhibited minimum errors with CP and HRS in response to dependable variables which is concluded as best formulation.
Highlights
New technologies are revolutionizing the drug discovery and the novel formulation development in pharmaceutical industries
It has been a tough challenge for the pharmaceutical scientists to formulate oral disintegrating tablet for poorly soluble drugs as it requires enhancement in the dissolution rates [3,4,5].The techniques that have been generally employed for enhancing the solubility of drugs include micronisation and cyclodextrin-complexation which involves the use of surfactants, solubilizers and super disintegrants
The current study reveals the optimization procedure of preparing a series of Oral Disintegrating Tablets (ODT) tablet formulations for valsartan by varying the concentrations of formulation ingredients in a systematic manner
Summary
New technologies are revolutionizing the drug discovery and the novel formulation development in pharmaceutical industries. It has been a tough challenge for the pharmaceutical scientists to formulate oral disintegrating tablet for poorly soluble drugs as it requires enhancement in the dissolution rates [3,4,5].The techniques that have been generally employed for enhancing the solubility of drugs include micronisation and cyclodextrin-complexation which involves the use of surfactants, solubilizers and super disintegrants. They improve the solubility of class-II drugs by increasing the dissolution rate and bioavailability significantly [6]. The super disintegrants are added to facilitate drug release and improve the dissolution rate [7,8,9]
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