Pullulan based oral thin film formulation of zolmitriptan: Development and optimization using factorial design

The goal 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 selected as casting surface, water-miscible plasticizer and sweetener for OTF, respectively. A 32 factorial design was used to study the effect of amount of PEG 400 (X-1) and sucralose (X-2) as independent variables on tensile strength (Y-1), elasticity (Y-2), % in-vitro drug release in phosphate buffer of pH 6.8 at 5 min (Q(5min), Y-3) and overall taste of OTF (Y-4) as responses. OTF of batch F4 (PEG 400, 200 mg; sucralose, 12 mg) was identified as an optimized batch showing in-vitro, in-vivo disintegration time 20.70 and 21.58 s, respectively; 95.53% Q(5min); 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 in combination to make palatable, stable OTF of zolmitriptan. (C) 2017 Elsevier B.V. All rights reserved.