al-Zein H, Riad L E, Abd-Elbary A
Department of Pharmaceutics, College of Pharmacy, Cairo University, Egypt.
Drug Dev Ind Pharm. 1999 Feb;25(2):223-7. doi: 10.1081/ddc-100102163.
The effect of packaging and storage on carbamazepine (CBZ) tablets was examined using Tegretol and Tegral, dispensed in strip seals, and Finlepsin, dispensed in bottles. Tegretol and Tegral tablets were stored in their original strips at 40 degrees C, 50 degrees C, and 60 degrees C for 6 months, 3 months, and 1 month, respectively, at 75% relative humidity (RH). Also, tablets were removed from their strips, placed in bottles, and exposed daily to 97% RH at 40 degrees C for 5 min for 30 days. Finlepsin tablets were exposed to 97% RH at 25 degrees C or 40 degrees C for 1 month by removing bottle caps daily for 5 min. Dissolution was used to assess in vitro tablet performance, and high-performance liquid chromatography (HPLC) was used to evaluate the chemical stability of CBZ. Results show that Tegretol tablets were not affected by the tested stress conditions. Tegral tablets, stored in their strips at 50 degrees C or 60 degrees C and 75% RH, showed increased disintegration and dissolution. The effect of 40 degrees C/75% RH for 6 months was similar to 1-month storage at 40 degrees C/97% RH; the tablets hardened and dissolved less than fresh Tegral tablets. Removal of Tegral tablets from their original strips resulted in only 7% dissolved in 60 min. For Finlepsin, the effect of 97% RH at 40 degrees C was more profound than 97% RH at 25 degrees C, but both conditions caused a decrease in dissolution, the extent of which was dependent on tablet position in the bottle. Stressed CBZ tablets, however, showed no change in the chemical stability of CBZ under all tested conditions.
使用以条密封包装的得理多（Tegretol）和 Tegral 以及以瓶装的利必通（Finlepsin），研究了包装和储存对卡马西平（CBZ）片剂的影响。得理多和 Tegral 片剂在相对湿度（RH）75%的条件下，分别于 40℃储存 6 个月、50℃储存 3 个月、60℃储存 1 个月，均保持原包装条形式。此外，将片剂从包装条中取出，放入瓶中，于 40℃下每天暴露于 97%RH 环境 5 分钟，持续 30 天。通过每天取下瓶盖 5 分钟的方式，使利必通片剂在 25℃或 40℃下暴露于 97%RH 环境 1 个月。采用溶出度来评估片剂的体外性能，并用高效液相色谱法（HPLC）评估 CBZ 的化学稳定性。结果表明，得理多片剂不受所测试的应力条件影响。Tegral 片剂在 50℃或 60℃以及 75%RH 条件下以原包装条形式储存时，崩解和溶出增加。40℃/75%RH 条件下储存 6 个月的效果与 40℃/97%RH 条件下储存 1 个月相似；片剂变硬，溶出度低于新鲜的 Tegral 片剂。将 Tegral 片剂从原包装条中取出后，60 分钟内仅有 7%溶解。对于利必通，40℃下 97%RH 的影响比 25℃下 97%RH 更显著，但两种条件均导致溶出度降低，降低程度取决于片剂在瓶中的位置。然而，在所有测试条件下，经处理的 CBZ 片剂的 CBZ 化学稳定性均未发生变化。
