室温下耐热性药物的稳定性。复习一下。

IF 1.3 Q4 PHARMACOLOGY & PHARMACY

FARMACIA HOSPITALARIA Pub Date : 2025-09-01 DOI:10.1016/j.farma.2024.12.001

Paloma Suárez-Casillas , Santiago José Lora-Escobar , Elena Montecatine-Alonso , Tao Li , Hector Acosta-García

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引用次数: 0

摘要

目的：本研究的目的是根据产品特性摘要（SmPC）中包含的信息、已发表的文献和生产制药公司提供的信息，以易于获取的格式审查和汇编有关室温（22-25 °C）下耐热性药物稳定性的现有信息。方法：选择本院纳入的需要在2 ~ 8 °C温度下保存的药品。用于临床试验的药物、冷冻药物和复方制剂均被排除在外。稳定性数据的第一个信息来源是SmPC。在没有资料的情况下，回顾已发表的文献和灰色文献。如果没有通过这些来源找到信息，则联系生产实验室。结果以表格格式显示，使信息更易于管理。该表包含以下信息：药品、商品名称、品牌（生产厂家）、室温最大稳定性、信息来源。所有药物的稳定性数据都包括在SmPC中，对于那些通过研究中使用的来源获得的额外信息，这被包括在一个单独的列中。结果：共筛选出203种耐热药物。37种（18.2%）室温稳定性为24 h， 36种（17.7%）室温稳定性为48 h-1 周，63种（31%）室温稳定性为1 周-1 月，52种（25.6%）室温稳定性大于1 月。然而，12种药物（6.3%）的稳定性小于24 h， 3种药物（1.4%）在室温下有其他稳定性数据。95种（46.7%）药物的稳定性信息来自SmPC， 56种（27.5%）来自已发表文献，36种（26.2%）来自生产厂家。在其中21个案例中，稳定性信息仅对特定案例、特定存储条件和特定批次的产品有效。结论：近年来，耐热药物的数量和影响呈指数增长。这些药物中的绝大多数在室温下可在一段可接受的时间内保持足够的稳定性，其中一些在相对较长的时间内保持稳定。迄今为止，我们的研究提供了这些药物稳定性的最大数据集。因此，我们的研究结果构成了一个非常有用的和最新的工具，为节省时间和金钱在医院药房单位。药品制造商应考虑在非推荐的储存条件下在SmPC中发表稳定性研究结果。

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Stability of thermolabile drugs at room temperature. A review

Purpose

The aim of this study was to review and compile the available information, in an easily accessible format, regarding the stability of thermolabile drugs at room temperature (22–25 °C), according to information contained in summary of product characteristics (SmPC), published literature, and information provided by the manufacturing pharmaceutical companies.

Methods

Drugs included in our hospital that required storage at a temperature between 2 and 8 °C were selected. Medications used in clinical trials, frozen drugs, and compounded formulations were excluded. The first source of information consulted for stability data was the SmPC. In case of no information available, published literature and gray literature were reviewed. If information was not found through these sources, the manufacturing laboratory was contacted.

The results are shown in table format to make the information more manageable. The table contains the following information: Drug product, trade name, brand name (manufacturer), maximum stability at room temperature, and information source. Stability data from SmPC were included for all medications, and for those with additional information obtained through the sources used in the study, this was included in a separate column.

Results

A total of 203 thermolabile drugs were selected. Thirty seven (18.2%) had a stability of 24 h at room temperature, 36 (17.7%) had a stability of 48 h–1 week, 63 (31%) had a stability of 1 week–1 month, and 52 (25.6%) had a stability of more than 1 month. However, 12 drugs (6.3%) had a stability of less than 24 h, and 3 drugs (1.4%) had other stability data at room temperature.

Stability information for 95 (46.7%) drugs was obtained from the SmPC, 56 (27.5%) from published literature, and 36 (26.2%) from manufacturers. In 21 of these cases, the stability information was valid exclusively for a specific case, with particular storage conditions and for a specific batch of the product.

Conclusion

The number and impact of thermolabile drugs have increased exponentially in recent years. The vast majority of these drugs maintain adequate stability at room temperature for an acceptable period of time, with some remaining stable for relatively long periods. To date, our study presents the largest dataset on the stability of these drugs. Therefore, the results of our study constitute a highly useful and up-to-date tool for saving time and money in hospital pharmacy units. Pharmaceutical manufacturers should consider publishing stability study results under non-recommended storage conditions in the SmPC.

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来源期刊

FARMACIA HOSPITALARIA PHARMACOLOGY & PHARMACY-

CiteScore

1.90

自引率

21.40%

发文量

审稿时长

37 days

期刊介绍： Una gran revista para acceder a los mejores artículos originales y revisiones de la farmacoterapia actual. Además, es Órgano de expresión científica de la Sociedad Española de Farmacia Hospitalaria, y está indexada en Index Medicus/Medline, EMBASE/Excerpta Médica, Alert, Internacional Pharmaceutical Abstracts y SCOPUS.