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Use of chitosan as pharmaceutical excipient in ocular drug delivery systems: Sterilization and pharmacokinetics.
Journal of Biomedical Materials Research Part B: Applied Biomaterials ( IF 3.4 ) Pub Date : 2020-01-22 , DOI: 10.1002/jbm.b.34560
Juçara R Franca 1 , Leonardo L Fuscaldi 2 , Tatiana G Ribeiro 1 , Giselle Foureaux 3 , Aina L A Cesar 1 , Rachel O Castilho 1 , Sebastião Cronemberger 4 , Anderson J Ferreira 3 , Simone O A Fernandes 2 , Valbert N Cardoso 2 , André A G Faraco 1
Affiliation  

The use of chitosan as a pharmaceutical excipient in the ocular field is already established. Nevertheless, some aspects related to its ocular administration, such as sterilization and excipient's pharmacokinetics, remain unclear. So, in this study, we evaluated those two relevant aspects, related to chitosan administration in eye. We used chitosan‐based ocular inserts (CI) as formulation model. CI were produced by solvent/casting method and sterilized by saturated steam. Sterilization was confirmed by direct inoculation of inserts in suitable microbiological growth media. Physicochemical characterization of inserts before and after sterilization was performed. Results suggested that, although steam sterilization changed the arrangement of the matrix, the heat and the humidity did not modify the structure of the main polymeric chain. Pharmacokinetics of CI radiolabeled with technetium‐99m (99mTc) was assessed by scintigraphic images and ex vivo biodistribution study, after ocular administration in male Wistar rats. Scintigraphic and images analysis and ex vivo biodistribution study showed that the insert remained mainly in the eye until 6 hr after administration and its degradation products began to migrate to the abdominal cavity after 18 hr. Together, these data represent an important step forward the manufacturing and the clinical application of CI in the ophthalmic field.

中文翻译:

壳聚糖在眼部给药系统中作为药物赋形剂的用途:灭菌和药代动力学。

壳聚糖作为眼科药物赋形剂的用途已经确立。然而,与其眼部给药相关的一些方面,如灭菌和赋形剂的药代动力学,仍不清楚。因此,在本研究中,我们评估了与眼部壳聚糖给药相关的两个相关方面。我们使用基于壳聚糖的眼部插入物 (CI) 作为配方模型。CI采用溶剂/浇铸法生产,饱和蒸汽灭菌。通过在合适的微生物生长培养基中直接接种插入物来确认灭菌。执行灭菌前后插入物的物理化学表征。结果表明,虽然蒸汽灭菌改变了基质的排列,但热量和湿度并没有改变主聚合物链的结构。在雄性 Wistar 大鼠眼部给药后,99m Tc) 通过闪烁扫描图像和离体生物分布研究进行评估。闪烁扫描和图像分析以及离体生物分布研究表明,在给药后 6 小时内,插入物主要留在眼内,18 小时后其降解产物开始迁移到腹腔。总之,这些数据代表了 CI 在眼科领域的制造和临床应用的重要一步。
更新日期:2020-01-22
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