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首页> 外文期刊>Journal of Drug Delivery and Therapeutics >Formulation and Evaluation of Transdermal Patch for Atomoxetine hydrochloride
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Formulation and Evaluation of Transdermal Patch for Atomoxetine hydrochloride

机译:盐酸阿托西汀透皮贴剂的研制与评价

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The aim of this study was to develop transdermal patch of Atomoxetine hydrochloride which has good mechanical properties. The transdermal patches were preapared used solvent casting method. Different groups of films with drug were prepared using different amalgamations of polymers such as HPMC (various grades), Polyox303, Eudragit RL 100.Considering solubility of drug and polymer, the solvent system of water: ethanol was chosen. In-vitro release of drug substance was performed using phosphate buffer solution (PBS) pH 7.4. Compatibility of drug with different excipient (drug: excipient in the ratio 1:1) was carried out using Fourier Transform Infra-Red Spectroscopy (FTIR). Evaluation test such as weight variation, content uniformity, drug content, folding endurance, thickness, in-vitro dissolution and in-vitro disintegration were done. The folding endurance of the all batches found less than 500 times . The percentages of drug distribution was found in between 72 to 100%.The formulation F4 containing a combination of HPMC and Eudragit showed maximum drug release of 95.26%. The method employed to prepare patches was capable of producing patches with almost uniform drug distribution. Stability studies were conducted as per ICH guidlines (40±2sup○/supC at 75±5% RH) for optimized formulations and was found to be stable.
机译:这项研究的目的是开发具有良好机械性能的盐酸阿托西汀的透皮贴剂。透皮贴剂采用溶剂浇铸法制备。使用不同的聚合物(如HPMC(各种等级),Polyox303,Eudragit RL 100)的不同聚合物制备了不同组的含药物薄膜。考虑到药物和聚合物的溶解性,选择水:乙醇的溶剂体系。使用pH 7.4的磷酸盐缓冲溶液(PBS)进行药物的体外释放。使用傅立叶变换红外光谱(FTIR)进行药物与不同赋形剂(药物:赋形剂的比例为1:1)的相容性。进行了诸如体重变化,含量均匀性,药物含量,耐折性,厚度,体外溶出度和体外崩解性的评估测试。所有批次的耐折性均小于500倍。发现药物分布的百分比在72%至100%之间。包含HPMC和Eudragit组合的制剂F4显示最大药物释放为95.26%。用于制备贴剂的方法能够产生具有几乎均匀的药物分布的贴剂。根据ICH准则(在75±5%RH下40±2 ○ C)进行稳定性研究,以优化配方,发现是稳定的。

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