Thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, and biotin hard gelatin capsules prepared in advance and stored for the treatment of pediatric metabolic diseases: a safer alternative

Abstract

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.

Fig 1. Content variation of vitamin capsules stored at ambient temperature (25 ^°C/ 60% RH) over time.

Fig 2. Content variation of thiamine hydrochloride 50 mg capsules from protocol 2 stored at ambient temperature (25 ^°C/ 60% RH) over time.