Development of immediate release liquid fill formulations for soft gels of sumatriptan succinate

Abstract

The present investigation includes the preparation of liquid filling formulations for soft gels using an anti-migraine drug Sumatriptan Succinate (SMT), in order to improve its rate of absorption and thereby its bioavailability. Formulations   were   prepared   using   excipients   like   polyethylene   glycol   (PEG-­400),   propylene   glycol   (PG), Polyvinylpyrrolidone  (PVP  K-­30),  antioxidants,  tween-80,  SLS,  ethanol  and  purified  water.  Prepared  formulations were evaluated for appearance, pH, drug content uniformity, drug-excipients compatibility, viscosity, and stability and  in-­vitro  dissolution  studies.  The  compatibility  between  the  drug  and  excipients  in  the  formulations  was confirmed by FTIR spectra and DSC thermograms. The drug contents were in the range of 97.65 to 99.62 and the viscosity was in the range of 37.95 to 452.93 cps for all the developed formulations. Formulation F1 containing PEG-­400  (20%)/PG  (20%)/water  (52%)  system  gave  superior  drug  release  when  compared  to  other  liquid  filling formulations and complete drug release (100%) was observed at the end of 90 seconds. Stability studies were conducted  for  all  formulations  (F1-­F10)  over  a  period  of  6  months  at  room  temperature  (30ºC/65%RH).  From these studies, it can be concluded that SMT liquid fill formulations for soft gels were successfully prepared. The in-­vitro dissolution properties of SMT liquid fill formulations for soft gels were superior when compared to pure SMT and marketed SMT.