Stability of Pyridoxine-Enriched Parenteral Nutrition for Homocystinuria Management

Homocystinuria, a rare metabolic disorder, often requires an individualized medical approach, including parenteral nutrition (PN) in cases where oral or enteral feeding is not possible.This study investigated the stability of PN admixtures enriched with a high dose of pyridoxine (vitamin B6, 100 mg/ day) that can be used to treat homocystinuria.Six different PN formulations were analyzed, including one lipid-free (2-in-1) and five all-in-one (3-in-1) admixtures, stored under varying conditions: 5 1C and 25 1C, with and without light exposure.Key stability parameters, including mean droplet diameter (MDD), zeta potential (ZP), pH of the PN admixture, and pyridoxine content, were systematically monitored over a seven-day period.The results showed that all PN admixtures maintained physical stability in accordance with USP standards, with MDD below 500 nm, stable pH levels, and negative ZP.However, the stability of pyridoxine was significantly influenced by its composition and storage conditions.The PN admixtures stored at 5 1C under light-protected conditions showed minimal degradation of pyridoxine, whereas those exposed to light at 25 1C exhibited the highest degradation rates.These findings emphasize the critical importance of preparing PN admixtures enriched with a high dose of pyridoxine immediately before use, and storing them under light-protected conditions to preserve their therapeutic efficacy.The study provides valuable insights into the stability of pyridoxine in PN, supporting safe and effective treatment protocols for patients with homocystinuria.