Spray Glucagon: A Checklist Guide to Product Qualification & Certification Documents
Abstract: Spray glucagon, a peptide-based rescue therapy for severe hypoglycemia, requires rigorous product qualification and certification documentation. This checklist guide examines peptide composition, stability, and delivery technologies, contrasting brands like Baqsimi (Eli Lilly) with emerging generics. Market trends show a 12.4% CAGR (2023–2030) driven by diabetes prevalence. Key parameters include bioavailability (15–25% intranasal vs. 30–40% injectable), shelf-life (24–36 months), and cold-chain logistics (2–8°C). Certification documents (e.g., FDA NDA, EMA MAA, GMP, ISO 13485) are critical for compliance. Selection criteria prioritize purity (>98%), excipient compatibility, and device reliability. Industry data indicate 78% of clinicians prefer spray glucagon for caregiver ease, yet regulatory hurdles persist. This guide synthesizes technical, market, and regulatory insights for informed peptide product procurement.