CritiTech, Inc, 1321 Wakarusa Drive, Suite 2102, Lawrence, Kansas 66049, USA.
AAPS PharmSciTech. 2012 Jun;13(2):582-9. doi: 10.1208/s12249-012-9777-4. Epub 2012 Apr 14.
A process is described using supercritical carbon dioxide to extract organic solvents from drug solutions contained in 30-mL serum vials. We report drying times of less than 1 h with quantitative recovery of sterile drug. A six-log reduction of three spore types used as biological indicators is achieved with direct addition of peracetic acid to a final concentration of approximately 5 mM (~0.04 %) to the drug solution in the vial. Analysis of two drugs, acetaminophen and paclitaxel, indicated no drug degradation as a result of the treatment. Furthermore, analysis of the processed drug substance showed that no residual peracetic acid could be detected in the final product. We have demonstrated an effective means to simultaneously dry and sterilize active pharmaceutical ingredients from organic solvents directly in a dispensing container.
介绍了一种使用超临界二氧化碳从 30mL 血清小瓶中含药物溶液中提取有机溶剂的方法。我们报告了不到 1 小时的干燥时间，并且可以定量回收无菌药物。通过向小瓶中药物溶液中直接添加终浓度约为 5mM（~0.04%）的过氧乙酸，可实现三种孢子类型的生物指示剂的六对数减少。对两种药物（对乙酰氨基酚和紫杉醇）的分析表明，处理后药物没有降解。此外，对处理后的药物进行分析表明，最终产品中无法检测到残留的过氧乙酸。我们已经证明了一种有效的方法，可以直接在分配容器中从有机溶剂中同时干燥和灭菌活性药物成分。
