ExcipioForm: Operationalizing excipient safety through a deterministic decision system for pediatric extemporaneous...

Area of Science:

• Pharmacology
• Pharmaceutical Technology
• Computational Toxicology

Background:

• Pediatric patients often lack age-appropriate dosage forms, leading to reliance on extemporaneous compounding.
• This practice increases risks of excipient toxicity and formulation instability, especially in neonates.
• Existing digital health tools lack integration of real-time formulation data with age-specific toxicology.

Purpose of the Study:

• To introduce ExcipioForm, a novel screening framework for automated excipient safety assessment in pediatric liquid formulations.
• To utilize oral antihypertensives as initial models for evaluating the framework's efficacy.
• To enhance patient safety and compounding governance at the point of care.

Main Methods:

• ExcipioForm employs a deterministic screening framework with a three-layer validation pipeline.
• Inputs include age-dependent clinical toxicity, API pH-stability constraints, and quantitative exposure limits.
• A standardized database of 81 excipients and 128 clinical rules powers the risk assessment engine.

Main Results:

• The framework successfully evaluated 50 simulated pediatric formulation cases with high efficiency (mean latency of 2.27 ms per case).
• Reproducible risk detection was confirmed, identifying issues like neonatal benzyl alcohol contraindications and polyol concentration thresholds.
• The system translates static toxicological data into an active, auditable verification workflow.

Conclusions:

• ExcipioForm provides a robust and reproducible foundation for improving pediatric patient safety in compounding.
• The framework acts as a decision-support tool to mitigate toxicological risks and standardize compounding practices.
• It enhances clinician judgment in pediatric pharmacotherapy by providing real-time safety verification.