Pyridoxine chlorhydrate forced degradation.

The treatment of several pediatric metabolic diseases involves vitamins supplementation. Among these, thiamine, riboflavin, pyridoxine and biotin can be prescribed and compounded as hard gelatin capsules. In compounding practice, a medication can be done extemporaneously, leading to a risk of error. However, a medication can also be done in advance, analytically controlled and stored. Such practice reduce the risk of error and decrease the cost, but also imposes the realization of stability studies to establish beyond-use-dates. Thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, and biotin hard gelatin capsules chromatographic and microbiological methods were both validated and used to perform stability studies. Thiamine hydrochloride 50 mg hard gelatin capsules with microcrystalline cellulose and silica as excipients are stable for 6 months when stored at 25 °C/ 60% RH protected from light. Riboflavin 50 mg with microcrystalline cellulose, pyridoxine hydrochloride 50 mg with microcrystalline cellulose and biotin 40 mg with microcrystalline cellulose/silica are stable for one year when stored at 25 °C/ 60% RH protected from light. These results allow the compounding in advance of batches of 300 capsules controlled, stored, and quickly dispensed in case of an emergency, such decreasing the risk of error and/or iatrogenic event.

多种儿科代谢性疾病的治疗需辅以维生素补充疗法。其中，硫胺素（thiamine）、核黄素（riboflavin）、吡哆醇（pyridoxine）与生物素（biotin）可被开具处方，并配制成硬明胶胶囊（hard gelatin capsules）。在药剂调配实操中，药物可临时配制，此举存在引发差错的风险。不过，药物也可预先配制、经分析检验管控后储存。此类做法既能降低差错风险、节约成本，同时也需要开展稳定性研究以确定药品的使用期限（beyond-use-dates）。针对盐酸硫胺素（thiamine hydrochloride）、核黄素、盐酸吡哆醇（pyridoxine hydrochloride）及生物素硬明胶胶囊的色谱法与微生物法均已完成方法学验证，并被用于稳定性研究。以微晶纤维素（microcrystalline cellulose）与二氧化硅（silica）为辅料的50mg盐酸硫胺素硬明胶胶囊，在25℃/60%相对湿度（RH）避光储存条件下，可稳定保存6个月。以微晶纤维素为辅料的50mg核黄素硬明胶胶囊、以微晶纤维素为辅料的50mg盐酸吡哆醇硬明胶胶囊，以及以微晶纤维素/二氧化硅为辅料的40mg生物素硬明胶胶囊，在25℃/60%相对湿度避光储存条件下，可稳定保存1年。上述研究结果支持可预先批量配制300粒经管控的胶囊，储存后可在紧急情况下快速调配发放，从而降低差错风险及/或医源性事件（iatrogenic event）的发生概率。