Department of Pharmaceutics, S.S.R. College of Pharmacy, Sayli-Silvassa Road, Sayli, Silvassa, U.T. of Dadra and Nagar Haveli, 396230, India.
Department of Pharmaceutics, S.S.R. College of Pharmacy, Sayli-Silvassa Road, Sayli, Silvassa, U.T. of Dadra and Nagar Haveli, 396230, India.
Int J Biol Macromol. 2018 Feb;107(Pt B):2075-2085. doi: 10.1016/j.ijbiomac.2017.10.082. Epub 2017 Oct 23.
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 3 factorial design was used to study the effect of amount of PEG 400 (X) and sucralose (X) as independent variables on tensile strength (Y), elasticity (Y), % in-vitro drug release in phosphate buffer of pH 6.8 at 5min (Q, Y) and overall taste of OTF (Y) as responses. OTF of batch F4 (PEG 400, 200mg; sucralose, 12mg) was identified as an optimized batch showing in-vitro, in-vivo disintegration time 20.70 and 21.58s, respectively; 95.53% Q; 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.
本研究的目的是通过溶剂浇铸法制备并表征依托泊苷的普鲁兰基口腔薄膜（OTF）。基于初步试验，选择玻璃、PEG400 和蔗糖作为浇铸表面、水混溶性增塑剂和甜味剂分别用于 OTF。采用 3 因素设计研究 PEG400（X）和蔗糖（X）的用量对拉伸强度（Y）、弹性（Y）、在磷酸盐缓冲液（pH6.8）中 5min 的体外药物释放率（Q，Y）和 OTF 整体口感（Y）的影响。批 F4（PEG400，200mg；蔗糖，12mg）的 OTF 被鉴定为优化批次，具有体外、体内崩解时间分别为 20.70 和 21.58s；95.53%Q；满意的厚度、强度、伸长率、易于处理、口感光滑、整体口感极佳；普鲁兰 OTF 中所有成分均匀分布（SEM 研究）；以及在规定条件下稳定的薄膜，这表明普鲁兰、PEG400 和蔗糖联合使用可制备出可口、稳定的依托泊苷 OTF。
