ExcipioForm: Operationalizing excipient safety through a deterministic decision system for pediatric extemporaneous formulations - Part i.

The lack of age-appropriate dosage forms forces a heavy reliance on pediatric extemporaneous compounding, increasing risks of excipient-related toxicity and physicochemical instability, particularly in neonates. However, current digital health tools rarely integrate real-time formulation parameters with age-stratified toxicological metrics. This study introduces ExcipioForm, a deterministic screening framework designed to automate excipient safety assessment in pediatric liquid formulations, using oral antihypertensives as initial models. The system operates risk assessment by processing multi-dimensional inputs through a three-layer validation pipeline: age-dependent clinical toxicity boundaries, active pharmaceutical ingredient pH-stability constraints, and quantitative exposure limits. Powered by a standardized relational database of 81 excipients and 128 clinical rules, the engine evaluated 50 simulated formulation cases with a mean execution latency of 2.27 ms per case. Demonstrative scenarios confirmed reproducible risk detection, including neonatal benzyl alcohol contraindications and concentration-dependent polyol thresholds. By translating static toxicological data into an active, auditable verification workflow, ExcipioForm provides a robust, reproducible foundation to enhance patient safety and compounding governance at the point of care. Ultimately, this framework functions as a robust decision-support tool designed to mitigate toxicological risks and standardize compounding practices, serving to inform and enhance clinician judgment in pediatric pharmacotherapy.