J Am Pharm Assoc (2003). 2019 Jul-Aug;59(4):514-520. doi: 10.1016/j.japh.2019.02.012. Epub 2019 Apr 9.
To investigate the stability and beyond-use date (BUD) of topical gabapentin in 3 commonly used bases.
Lipoderm cream, Versabase gel, and Emollient cream were used to compound gabapentin (10%). The products were stored in Ecolojars, kept at 25°C, 4°C, and 40°C, and samples were collected on different days (days 0, 14, 28, and 90). Potency, stability, and organoleptic changes were monitored.
At 25°C and 40°C, the potency of gabapentin in Lipoderm cream significantly increased (P < 0.05) after 28 and 90 days, respectively. In contrast, gabapentin degraded in Emollient cream (P < 0.05). At 25°C, the organoleptic properties of the drug compounded with Lipoderm cream (25°C) remained consistent for up to 28 days but showed signs of physical changes in other bases. Gabapentin recrystallized from Versabase gel and Emollient cream within 14 days.
Gabapentin compounded with Lipoderm cream for topical use was stable in Ecolojars for 28 days at 25°C. Under the same conditions, the drug was not stable in Versabase gel and Emollient cream. Based on our stability and potency data, the beyond-use date of currently dispensed gabapentin (10%) formulations with Lipoderm cream should not be extended beyond the currently assigned 30-day mark, even when refrigerated. It is unclear whether the stability of these formulations is improved if stored in air-tight containers.
研究三种常用基质中局部应用加巴喷丁的稳定性和失效日期（BUD）。
使用脂乳膏、Versabase 凝胶和润肤霜来配制 10%的加巴喷丁。将产品储存在 Ecolojars 中，分别在 25°C、4°C 和 40°C 下保存，并在不同时间（第 0、14、28 和 90 天）采集样品。监测效力、稳定性和感官变化。
在 25°C 和 40°C 下，脂乳膏中加巴喷丁的效力在分别在 28 和 90 天后显著增加（P < 0.05）。相比之下，加巴喷丁在润肤霜中降解（P < 0.05）。在 25°C 下，用脂乳膏（25°C）配制的药物的感官特性在长达 28 天内保持一致，但在其他基质中显示出物理变化的迹象。加巴喷丁在 14 天内从 Versabase 凝胶和润肤霜中重新结晶。
在 25°C 的 Ecolojars 中，脂乳膏中局部应用的加巴喷丁在 28 天内稳定。在相同条件下，该药物在 Versabase 凝胶和润肤霜中不稳定。根据我们的稳定性和效力数据，即使冷藏，目前配制成脂乳膏的加巴喷丁（10%）制剂的失效日期不应超过目前规定的 30 天标记。如果将这些制剂储存在密封容器中，其稳定性是否会提高尚不清楚。
