台灣地區藥品安定性試驗的平均動力學溫度及相對濕度   全文下載

The Mean Kinetic Temperature and Relative Humidity for Drugs and Products Stability Testing in Taiwan

本報告根據1991至1995年的台灣氣象資料，導出台灣地區的平均動力學溫度及相對濕度。對10至30 Kcal ／ mol 的活性化能位，計算各對應的平均動力學溫度。在台灣地區，分解反應的活性化能位為20 Kcal ／ mol 時，其平均動力學溫度為24.5°C，代表性相對濕度為77%。依據美國，日本及歐聯協調會（ICH）對氣候區I及II所用的安全係數，台灣地區藥品長期儲存試驗的溫濕度條件應為28 ± 2°C及90 ± 5%。此條件比ICH所規定的條件高3°C及高17%。溫度昇高3°C會導致分解速率常數增大34%。因之，在ICH地區有三年有效期限的藥品，在台灣地區將只有二年的有效期限。本報告也提出適用台灣地區的藥品安定性試驗條件。

In stability testing, the mean kinetic temperature (MKT) and relative humidity (RH) are two important factors which have an impact on the determination of the shelf-life of a drug product. This report presents the MKT and RH of Taiwan based on climate data from different areas of Taiwan between the years of 1991 and 1995. The data used in the calculation is from the Central Weather Bureau of Taiwan. Activation energies of 10 to 30 Kcal/mol are considered. The results show that the MKT of Taiwan is 24.5 °C given a typical activation energy of 20 Kcal/mol, and the RH is 77%. Drug products degrade faster under higher MKT and RH. Based on analogous safety margins for MKT and RH in climatic zones I (19.7 °C/43.9%, MKTIRH) and II (22.8 °C/52.9%) as specified in the international conference on harmonization (ICH) stability testing guideline, the long-term storage test conditions for Taiwan would be 28 ± 2 °C and 90 ± 5% for temperature and humidity, respectively. These derived storage conditions are in fact 3 °C and 17% higher than those in the ICH guideline specified for the tripartite countries (EC, Japan and USA). For a 3 °C increment in MKT, the degradation rate constant will actually increase by about 34 %. In consequence, a product marketed in Taiwan will only have about 75% of the shelf-life that it would have in the tripartite countries. In this communication, the implications of the climatic conditions of Taiwan are examined. Appropriate storage test conditions for drugs and products stability testing in Taiwan are also proposed. 本報告根據1991至1995年的台灣氣象資料，導出台灣地區的平均動力學溫度及相對濕度。對10至30 Kcal ／ mol 的活性化能位，計算各對應的平均動力學溫度。在台灣地區，分解反應的活性化能位為20 Kcal ／ mol 時，其平均動力學溫度為24.5°C，代表性相對濕度為77%。依據美國，日本及歐聯協調會（ICH）對氣候區I及II所用的安全係數，台灣地區藥品長期儲存試驗的溫濕度條件應為28 ± 2°C及90 ± 5%。此條件比ICH所規定的條件高3°C及高17%。溫度昇高3°C會導致分解速率常數增大34%。因之，在ICH地區有三年有效期限的藥品，在台灣地區將只有二年的有效期限。本報告也提出適用台灣地區的藥品安定性試驗條件。