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热熔挤出法制备的载克林霉素玻璃体内植入剂的热分析表征

Thermoanalytical characterization of clindamycin-loaded intravitreal implants prepared by hot melt extrusion.

作者信息

Tamaddon Lana, Mostafavi Seyed Abolfazl, Karkhane Reza, Riazi-Esfahani Mohammad, Dorkoosh Farid Abedin, Rafiee-Tehrani Morteza

机构信息

Department of Pharmaceutics, School of Pharmacy and Pharmaceutical Sciences, Isfahan Pharmaceutical Sciences Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

Department of Ophthalmology, Eye Research Center, Farabi Eye Hospital, Tehran, Iran.

出版信息

Adv Biomed Res. 2015 Jul 27;4:147. doi: 10.4103/2277-9175.161563. eCollection 2015.

Abstract

BACKGROUND

The aim of the present study was to evaluate a non-destructive fabrication method in for the development of sustained-release poly (L, D-lactic acid)-based biodegradable clindamycin phosphate implants for the treatment of ocular toxoplasmosis.

MATERIALS AND METHODS

The rod-shaped intravitreal implants with an average length of 5 mm and a diameter of 0.4 mm were evaluated for their physicochemical parameters. Scanning electron microscopy (SEM), differential scanning calorimetry (DSC), Fourier-transform infrared (FTIR), and nuclear magnetic resonance (1H NMR) studies were employed in order to study the characteristics of these formulations.

RESULTS

Drug content uniformity test confirmed the uniformity in different implant batches. Furthermore, the DSC, FTIR, and 1H NMR studies proved that the fabrication process did not have any destructive effects either on the drug or on the polymer structures.

CONCLUSION

These studies showed that the developed sustained-release implants could be of interest for long-term sustained intraocular delivery of clindamycin, which can provide better patient compliance and also have good potential in terms of industrial feasibility.

摘要

背景

本研究的目的是评估一种非破坏性制造方法,用于开发基于聚(L,D-乳酸)的可生物降解磷酸克林霉素缓释植入物,以治疗眼部弓形虫病。

材料与方法

对平均长度为5毫米、直径为0.4毫米的棒状玻璃体内植入物的理化参数进行评估。采用扫描电子显微镜(SEM)、差示扫描量热法(DSC)、傅里叶变换红外光谱(FTIR)和核磁共振(1H NMR)研究来研究这些制剂的特性。

结果

药物含量均匀度测试证实了不同植入物批次的均匀性。此外,DSC、FTIR和1H NMR研究证明,制造过程对药物或聚合物结构均无任何破坏作用。

结论

这些研究表明,所开发的缓释植入物对于克林霉素的长期持续眼内给药可能具有重要意义,这可以提高患者的依从性,并且在工业可行性方面也具有良好的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb45/4549919/12f2feb25361/ABR-4-147-g001.jpg

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