使用因子设计开发Lornoxicam加载热触发眼部in-situ凝的配方开发
Heybet Kerem Polat1, Sedat Ünal2, Eren Aytekin3
1Republic of Turkey Ministry of Health, Turkish Medicines and Medical Devices Agency, Ankara.
Drug development and industrial pharmacy
|October 3, 2023
概括
开发了用lornoxicam装载的用于眼部炎症的in situ凝,其中包括基甲基纤维素和poloxamer 407以加强应用和控制释放. 优化的配方在体内表现出良好的细胞活力和安全性.
科学领域:
- 眼科医生 眼科 眼科
- 药品制造 药品制造 药品制造
- 材料科学 材料科学 材料科学
背景情况:
- 眼部炎症需要有效的药物输送系统.
- 洛诺西卡姆是一种非类固醇抗炎药物,有可能用于眼科.
- 现有的配方在眼睛表面的应用和去除方面可能会带来挑战.
研究的目的:
- 开发和评估用于眼部炎症治疗的洛诺西卡姆载入的in situ凝.
- 为了优化配方,使用基甲基纤维素和poloxamer 407来改善性能.
- 评估开发的眼部药物输送系统的体外和体内性能.
主要方法:
- 使用基基甲基纤维素和波洛克萨默 407.7 制备洛诺西卡姆加载的 in situ 凝.
- 使用三级因数设计,优化配方参数 (聚合物度,类型).
- 评估物理性质 (粘度,pH,凝温度/时间) 和体外药物释放动力学.
- 评估细胞活力 (体外) 和眼睛安全性 (体内Draize测试).
主要成果:
- 通过15%的波洛克萨默407和1%的氧基甲基纤维素实现了优化的配方.
- 优化的配方表现出适当的粘度,pH值和在体温下快速凝结.
- 实验室研究表明,最初的突发释放,随后持续释放洛诺西卡姆超过8小时.
- 该配方表现出良好的细胞活力,并且在体内没有不良影响.
结论:
- 配合基基甲基纤维素和波洛克萨默407配制的Lornoxicam载体的in situ凝是治疗眼部炎症的有希望的选择.
- 优化的配方在应用和持续的药物释放方面提供了优势.
- 开发的系统显示了安全有效的眼部药物输送的潜力.
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