A novel approach for the formulation optimization and evaluation of antiviral drugs by using starch phthalate A super disintegrant

Abstract

The main intension of the present work is to prepare starch phthalate, study its suitability as newlineSD and compare this with proved superdisintegrants. The best SD is selected to present Oral newlinedisintegrating tablets of Dolutegravir and Tenofovir, which disintegrates in short period of newlinetime in the oral cavity, thereby reducing the time of onset of pharmacological action. newlineStarch phthalate a novel superdisintegrant was prepared using potato starch and phthalic newlineanhydride. CP, SSG and CCS, were used as disintegrants MCC used as Binder and Sodium newlinesaccharin was used as sweetener and Magnesium stearate and talc were used as lubricant and newlineglidant respectively. The results of the drug excipient compatibility studies i.e FTIR newlinespectrum, DSC and XRD studies for Pure and Optimized formulation revealed that there was newlineno chemical interaction between the pure drug and excipients. Direct Compression newlinetechniqueusing 23 newlinefactorial designs (Design Expert) was employed to formulate the tablets, newlinebecause of its cost effectiveness and due to reduced number of manufacturing steps. The newlineprecompression parameters like bulk density, tapped density, Carr s index and angle of newlinerepose were determined. All the formulations showed acceptable flow properties. The post newlinecompression parameters like the hardness, thickness, friability and weight variation, wetting newlinetime, disintegration time, and Invitro release were carried out and the values were found to newlinebe within IP limits. The percentage drug content of all the tablets was found to be between newline86.45±1.75-99.42±0.87% of Dolutegravir and Tenofovir, which was within the acceptable newlinelimits. Among all the formulations TNF10, DF10 shows 90% drug release within 10 minutes. newlineThe drug release kinetics shows that the optimized formulation F10 follows First order drug newlinerelease. newline