Pharmaceutica Analytica Acta

Abstract

Design, Development and Formulation of Orodispersible Tablets of a Model Drug Using Response Surface Methodology

Lokesh PNV, Abdul Althaf S and Sailaja PB

The present investigation deals with preparation of Fast Dissolving Tablets (FDT) of Model drug (Telmisartan) and to determine the influence of the certain excipients on physical properties of the tablets and solubility. Direct compression technique was used because of its ease of access and contains limited number of unit operations. Glycine and SLS are used as wetting agent. Various superdisintegrants like Croscarmellose, Sodium starch glycolate, Crospovidone, Crospovidone-XL10 and Polacrallin potassium were screened to find the best formulation with good friability and disintegration values. Employing a 32 factorial design, the joint influence of two formulation variables like superdisintegrant concentration and ratio of diluents (MCCP: MANNITOL) on the disintegration time and friability were determined. The drug excipient compatibility studies were performed by FTIR and solubility changes are observed by dissolution using HPLC. The physical characteristics were analyzed by X-ray diffraction and supported by DSC studies. The multiple linear regression analysis was used to find the effect of these variables on physical properties of final formulation. Finally, a check-point batch is prepared to prove the validity of evolved method. Using the contour plot, effect of the independent variables on the responses was represented graphically. The stability studies of the optimized formula were carried as per ICH guidelines.