Bott Rubiana F, Oliveira Wanderley P
Faculdade de Ciências Farmacêuticas de Ribeirão Preto, Universidade de São Paulo, Ribeirão Preto, SP, Brazil.
Drug Dev Ind Pharm. 2007 Apr;33(4):393-401. doi: 10.1080/03639040600975022.
A review of the methodology for determination of the storage conditions for stability testing according to Schumacher/Grimm is presented in this paper. The purpose is to provide scientific information useful for the definition of storage conditions for stability testing of pharmaceuticals suitable to the region where the product will be dispensed. Special attention is given to stability testing in the new markets located in developing countries with very hot and humid climates. Finally, storage conditions for stability testing in the Brazilian regions were derived and examined comparatively with the guidelines of the world health organization (WHO) and regulatory bodies. The storage conditions were derived from the calculated values of the mean kinetic temperature and the relative humidity (RH). These parameters were estimated from daily values of dry and dew point temperatures of all Brazilian capitals from 1998 to 2002; collected in the morning (9 a.m.), in the afternoon (3 p.m.), and at night (9 p.m.). The Brazilian Center of Weather Forecast and Climatic Studies of the National Institute of Spatial Research (CPTEC/INPE) kindly furnished these data. Significant differences of the mean kinetic temperature (MKT) and relative humidity (RH) for Brazilian regions were observed. These results indicate the existence of a high climatic diversity between the Brazilian regions, making challenging the definition of a single storage condition for the stability testing. Some regions present RH values higher than 80%, giving support to the concerns of the WHO, indicating the necessity of revision of existing guidelines for stability testing mainly for very hot and humid regions.
本文介绍了根据舒马赫/格林方法确定稳定性试验储存条件的方法。目的是提供科学信息，有助于确定适合产品将被分发地区的药品稳定性试验的储存条件。特别关注气候非常炎热潮湿的发展中国家新市场的稳定性试验。最后，得出了巴西各地区稳定性试验的储存条件，并与世界卫生组织（WHO）和监管机构的指南进行了比较。储存条件是根据平均动力学温度和相对湿度（RH）的计算值得出的。这些参数是根据1998年至2002年巴西所有首府的干球温度和露点温度的日值估算的；在上午（9点）、下午（3点）和晚上（9点）收集。国家空间研究所巴西天气预报和气候研究中心（CPTEC/INPE） kindly提供了这些数据。观察到巴西各地区的平均动力学温度（MKT）和相对湿度（RH）存在显著差异。这些结果表明巴西各地区气候多样性很高，这使得为稳定性试验定义单一储存条件具有挑战性。一些地区的RH值高于80%，这支持了WHO的担忧，表明有必要修订现有的稳定性试验指南，主要针对非常炎热潮湿的地区。
