期刊
PHARMACEUTICS
卷 12, 期 9, 页码 -出版社
MDPI
DOI: 10.3390/pharmaceutics12090786
关键词
amphotericin B; gamma-cyclodextrins; stability; fungal keratitis
Fungal keratitis is a sight-threatening disease for which amphotericin B eye drops is one of the front-line treatments. Unfortunately, there are currently no commercial forms available, and there is little data concerning the long-term stability of compounded formulations based on intravenous dosages forms. New formulations of amphotericin B ophthalmic solutions solubilised with gamma-cyclodextrins have shown promising in-vitro results, but stability data is also lacking. The objective of this study was therefore to investigate the stability of a formulation of ready-to-use amphotericin B solubilised in 2-hydroxypropyl-gamma-cyclodextrins (AB-HP-gamma-CD), for 350 days. An amphotericin B deoxycholate (ABDC) formulation was used as a comparator. Analyses used were the following: visual inspection, turbidity, osmolality and pH measurements, amphotericin B quantification by a stability-indicating liquid chromatography method, breakdown product research, and sterility assay. AB-HP-gamma-CD formulation showed signs of chemical instability (loss of amphotericin B) after 28 and 56 days at 25 degrees C and 5 degrees C. Adding an antioxidant (ascorbic acid) to the formulation did not improve stability. ABDC formulation showed signs of physical instability (increased turbidy and amphotericin B precipitation) after 28 days and 168 days at 25 degrees C and 5 degrees C. As such, AB-HP-gamma-CD formulation does not provide long-term stability for ophthalmic amphotericin B solutions.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据