新型基质型盐酸曲马多透皮贴剂的制备与评价。

IF 1.8 Q3 PHARMACOLOGY & PHARMACY
Shankhadip Nandi, Saptarshi Mondal
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引用次数: 1

摘要

目的:经皮给药作为一种新型的给药系统,因其药物释放控制和提高患者依从性而成为科学家研究的热点。本研究采用适量合适的聚合物制备盐酸曲马多透皮贴剂。还计划控制药物从装置的渗透速率,以实现持续释放模式。材料与方法:通过改变辅料的用量,制备了若干剂型。通过理化参数和生物制药参数的校核,得到了符合要求的最佳配方。结果:傅里叶变换红外光谱结果未见异常峰,认为药物与聚合物具有相容性。不同理化参数的最小标准偏差值保证了制备方法能够熟练地开发出批次内变异性最小的贴剂。羟丙基甲基纤维素(HPMC)含量越高,贴片的拉伸强度、含水率和水蒸气透过率越高。高折叠耐力值(>200)表明制备的贴片具有柔韧性和与皮肤的完整性。编码为F26的仅含HPMC聚合物的透皮贴剂,通过体外透皮研究,在12小时内达到了理想的药物透皮率(65.51%)。结论:编码为F26的制剂具有持续的药物渗透速率和通口扩散动力学,是最优的贴剂,这也证实了该制剂具有基质型给药的能力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Fabrication and Evaluation of Matrix Type Novel Transdermal Patch Loaded with Tramadol Hydrochloride.

Objectives: Transdermal drug delivery as a novel drug delivery system has become a major research interest to the scientists for its controlled drug release and improved patient compliance. This study was conducted to develop an optimized transdermal patch of tramadol hydrochloride using an appropriate amount of suitable polymers. It was also planned to control the drug permeation rate from the device to achieve a sustained release pattern.

Materials and methods: Several numbers of formulations were prepared by altering the amount of excipients. Physicochemical and biopharmaceutical parameters were checked to get the optimized formulation with desired characteristics.

Results: Fourier transform infrared spectroscopy results displayed no abnormal peaks and hence concluded that the drug and polymers were compatible with each other. The minimum standard deviation values of different physicochemical parameters assured that the method of preparation was skilled to develop patches with least intra-batch variability. A higher percentage of hydroxypropyl methylcellulose (HPMC) resulted in the greater tensile strength, moisture content and water vapor transmission rate of the patches. A high folding endurance value (>200) indicated the flexibility of the prepared patches and their integrity to the skin. The transdermal patches coded as F26 containing only HPMC polymer demonstrated the desired drug permeation rate (65.51%) within 12 hours through ex vivo permeation studies.

Conclusion: The formulation coded as F26 was found to be the most optimized patch as it exhibited sustained drug permeation rate followed by higuchi diffusion kinetics, that also confirmed the capability of the formulation to exhibit matrix type drug delivery.

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来源期刊
CiteScore
3.60
自引率
5.90%
发文量
79
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