Abstract
FORMULATION AND EVALUATION OF LIQUID FILL FORMULATIONS FOR SOFT GELS OF ELVITEGRAVIR

Devineni Jyothirmayee*, Nunna Sravya and Rangani Vasumathi

ABSTRACT

The present investigation includes the preparation and evaluation of liquid fill formulations for soft gels using an anti retro-viral drug Elvitegravir(EVG), in order to improve its dissolution properties and there by its bioavailability. Formulations were prepared using excipients like polyethylene glycol-400(PEG 400), propylene glycol (PG), Polyvinylpyrrolidone (PVPK-30), DMSO, SLS and ethyl alcohol. Prepared formulations were evaluated for appearance, pH, drug content uniformity, viscosity, stability, and in-vitro dissolution studies. The compatibility between the drug and excipients in formulations was confirmed by FT-IR spectra. The drug content of the liquid fill formulations was found to be in the range of 97.55 to 99.63 and the viscosity was in the range of 34-132cps for all the developed formulations. Formulation F5 prepared using ethyl alcohol( 20.5% w/v),PEG-400(20% w/v), PG(15% w/v), DMSO(35% w/v) and 1% SLS w/w showed superior drug release when compared to other formulations (F1 , F2, F3 &F4), hence F5 was selected as optimized formulation and the complete release(100%) was observed at the end of 120seconds. Stability studies were conducted for all the formulations for a period of 6 months at room temperature(~30ºC/65%RH). From the studies, it can be concluded that EVG liquid fill formulations for soft gels were successfully prepared with in vitro dissolution properties superior when compard to EVG laboratory prepared formulation.EVG was earlier identified as a P-gp/MDR1 substrate. High concentrations of EVG present relatively briefly in the intestinal lumen during drug absorption can inhibit intestinal efflux transporters, such as P-gp.

Keywords: Elvitegravir, Bioavailability, Viscosity, Soft gels, p-gp efflux.


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