Pullulan based oral thin film formulation of zolmitriptan
28. October 2017
Thegoal of study was to formulate and characterize pullulan based oral thin film (OTF) of zolmitriptan by solvent casting method. Based on preliminary trials, glass, PEG 400 and sucralose were selectedas casting surface, water-miscible plasticizer and sweetener for OTF, respectively. A 32 factorial design was used to study the effectof amount of PEG 400 (X1) and sucralose (X2) as independent variables on tensile strength (Y1), elasticity (Y2), % in-vitro drug release in phosphate buffer of pH 6.8 at 5 min (Q5min, Y3) and overall taste of OTF (Y4) as responses. OTF of batch F4 (PEG 400, 200 mg; sucralose, 12 mg) was identified as an optimized batch showing in-vitro, in-vivo disintegrationtime 20.70 and 21.58 s, respectively; 95.53% Q5min; satisfactory thickness, strength, % elongation, ease of handling, smooth mouthfeel,excellent overall taste; even distribution of all ingredients in pullulan OTF (SEM study); and stable film at specified conditions concluding that pullulan, PEG 400 and sucralose are used incombination to make palatable, stable OTF of zolmitriptan.