Formulation and evaluation of fast dissolving oral films containing ropinirole HCl and pramipexole dihydrochloride monohydrate

Abstract

ix newlineABSTRACT newlineThe present research outline the systematic approach for design and evaluation of fast newlinedissolving oral films (FDOFs) of Pramipexole HCl monohydrate and Ropinirole HCl newlineto enhance the therapeutic efficacy and provide rapid onset of action in patients newlinesuffering from cancer drugs induced vomiting. newlineInitially 27 formulations each of Pramipexole HCl and Ropinirole HCl were prepared newlineby solvent casting method and evaluated.The evaluation parameters including the drug newlinecontent, folding endurance, thickness and disintegration time were found within the newlinelimit. All the formulation parameters optimized using 33 response surface method with newlinethree polymers at three different levels (low, middle and high concentrations) by using newlineDesign of experiment software. newlineFor Pramipexole HCl the formulation PF24 with minimum newlinethickness(0.10mm),maximum tensile strength(16gm/cm2),maximum folding newlineendurance(120),maximum content uniformity(99.29 %), minimum disintegration time newlineof 19 sec, maximum drug of 99.21% in 10 min was chosen as optimized formulation. newlineThe pharmacokinetic study conducted on rabbits indicate that enhanced drug absorption newlinewith higher amount of drug concentration in blood from film formulation in comparison newlineto marketed product. Hence the fast dissolving film formulation of Pramipexole HCl newlineproved to be innovative approach for the delivery of drug for treating Parkinson s. newlineSimilarly the formulations F4 of Ropinirole HCl with minimum disintegration time of newline11 sec, 99% content uniformity, maximum thickness (16 gm/cm2), maximum folding newlineendurance (120)and optimal surface pH of 6.9 and 99.68±1.52% drug release in 10 newlinemin was choosen optimal.The pharmacokinetic evaluation of Ropinirole HCl fast newlinedissolving film (F4) conforms improved delivery and quick onset of action of newlineRopinirole HCl. A significant increase in Cmax observed in F4 when compared to newlinex newlinemarketed product. AUC0-and#8734; infinity for film formulation was higher than the marketed newlineproduct indicating enhancement systemic absorption of drug when compared to newlinemarketed product. Henc