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Manufacturing and Process Scale-Up

Stability‑Optimized High‑Concentration Hydroxocobalamin (50 mg/mL) for Pediatric Parenteral Administration

Léanne Bui – Master’s Student in Pharmaceutical Sciences, Pharmacy, Université de Montréal; Jean-Marc Forest – Lead of Compounding and Manufacturing Unit, Pharmacy, CHU Sainte-Justine; Grégoire Leclair – Full Professor, Pharmacy, Université de Montréal
Introduction:

Hydroxocobalamin is essential for rare pediatric metabolic disorders requiring high doses [1,4]. Current injectable forms (5 mg/mL) lead to large intramuscular volumes poorly tolerated in children [1]. In Canada, no marketed product is available, limiting access. A higher‑concentration formulation is needed for hospital compounding. This study aimed to develop and evaluate a stable 50 mg/mL injectable solution to reduce injection volume and ensure safety and feasibility [2,3].

Learning Objectives:

  • describe the buffer‑dependent stability determinants of 50 mg/mL hydroxocobalamin.
  • explain the analytical methods used to quantify chemical stability over time.
  • discuss the implications of high‑concentration formulations for pediatric compounding.