Koteswari Poluri, Sravanthi G Puja, Mounika M, Mohammed Rafi S K, Nirosha K
Department of Pharmaceutics, Hindu College of Pharmacy, Guntur, Andhra Pradesh, India.
Department of Pharmaceutics, Vignan Pharmacy College, Guntur, Andhra Pradesh, India.
Int J Pharm Investig. 2016 Oct-Dec;6(4):201-206. doi: 10.4103/2230-973X.195927.
The present investigation involves the development of zolmitriptan oral soluble film (OSF) formulations and optimization with quality by design (QBD) using natural polymers and evaluation.
Initially, various natural polymers such as sodium alginate, pectin, and gelatin were screened by casting films using solvent casting technique and the prepared films were evaluated. Based on the physical and mechanical properties, sodium alginate was selected as best film former and zolmitriptan-loaded films were casted. The formulation was optimized with the help of 2 factorial experimental designs (QBD) in which sodium alginate concentration and plasticizer concentrations were used as factors and at two levels. The drug-loaded films were evaluated for various mechanical, physicochemical properties, and drug release properties. Factor effects were interpreted by calculating the main factor effects and by plotting the interaction plots.
Thickness of the films, disintegration time, and percent drug loading efficiency were in the range of 0.698 ± 0.13-1.318 ± 0.22 mm, 175 ± 3.1-280 ± 1.7 s, and 68.34 ± 0.5-94.70 ± 0.7% w/v, respectively. Cumulative percent drug released was 61.8 ± 2.6-94.7 ± 4.1% after 30 min. Polymer concentration at two levels of plasticizer had statistically significant effect on drug loading efficiency and drug release rate. formulation was found to be excellent in drug loading efficiency and drug release profiles; hence, drug excipient compatibility studies using Fourier transform infrared spectroscopy and stability studies for 60 days were carried out for formulation and found to be stable.
Sodium alginate OSFs containing zolmitriptan was successfully prepared, optimized, and evaluated.
本研究涉及佐米曲普坦口腔可溶性薄膜（OSF）制剂的开发，并采用质量源于设计（QBD）方法，使用天然聚合物进行优化及评价。
首先，采用溶剂浇铸技术通过浇铸薄膜对各种天然聚合物（如海藻酸钠、果胶和明胶）进行筛选，并对制备的薄膜进行评价。基于物理和机械性能，选择海藻酸钠作为最佳成膜材料，并浇铸载有佐米曲普坦的薄膜。借助二因素实验设计（QBD）对制剂进行优化，其中海藻酸钠浓度和增塑剂浓度作为因素，设定两个水平。对载药薄膜的各种机械、物理化学性质及药物释放性质进行评价。通过计算主要因素效应和绘制相互作用图来解释因素效应。
薄膜厚度、崩解时间和药物负载效率百分比分别在0.698±0.13 - 1.318±0.22毫米、175±3.1 - 280±1.7秒和68.34±0.5 - 94.70±0.7% w/v范围内。30分钟后药物累积释放百分比为61.8±2.6 - 94.7±4.1%。在增塑剂的两个水平下，聚合物浓度对药物负载效率和药物释放速率有统计学显著影响。该制剂在药物负载效率和药物释放曲线方面表现优异；因此，对该制剂进行了傅里叶变换红外光谱法药物辅料相容性研究和60天稳定性研究，结果表明其稳定。
成功制备、优化并评价了含佐米曲普坦的海藻酸钠OSF。
