Chilamkurti R N
Baxter Healthcare Corporation, I.V. Systems Division, Round Lake, Illinois.
J Parenter Sci Technol. 1992 Jul-Aug;46(4):124-9.
Many of the intravenously administered drug compounds are formulated as frozen dosage forms due to lack of sufficient chemical stability at room or refrigerated temperatures. The product is stored in a freezer in the hospital pharmacy and thawed prior to its use. These products therefore, require a long-term frozen shelf-life plus a short-term room temperature and/or refrigerated temperature shelf-life. The formulation is optimized for overall stability in the frozen state as well as in the thawed state. In this paper, the significance of phase changes in the frozen state and the influence of various formulation factors such as drug concentration, diluent, buffer concentration, pH, and raw material purity on the drug stability in the frozen state is reviewed. An overview of analytical and manufacturing considerations unique to frozen products is also presented.
由于许多静脉给药的药物化合物在室温和冷藏温度下缺乏足够的化学稳定性，因此被制成冷冻剂型。该产品储存在医院药房的冰箱中，并在使用前解冻。因此，这些产品需要长期冷冻保质期以及短期室温保质期和/或冷藏温度保质期。该制剂针对冷冻状态以及解冻状态下的整体稳定性进行了优化。本文综述了冷冻状态下相变的重要性以及药物浓度、稀释剂、缓冲液浓度、pH值和原料纯度等各种制剂因素对冷冻状态下药物稳定性的影响。还介绍了冷冻产品特有的分析和生产方面的考虑因素概述。
