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

Area of Science:

• Pharmaceutical Sciences
• Computational Toxicology
• Pediatric Pharmacology

Background:

• Pediatric extemporaneous compounding is prevalent due to a lack of age-appropriate dosage forms.
• This reliance increases risks of excipient toxicity and physicochemical instability, especially in neonates.
• Existing digital health tools lack integration of real-time formulation data with age-stratified toxicology.

Purpose of the Study:

• To introduce ExcipioForm, a novel 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 processed 50 simulated pediatric formulation cases with a mean latency of 2.27 ms per case.
• ExcipioForm successfully detected risks, including neonatal benzyl alcohol contraindications and polyol concentration thresholds.
• Reproducible risk detection was confirmed across demonstrative scenarios.

Conclusions:

• ExcipioForm translates static toxicological data into an active, auditable verification workflow.
• The framework offers a robust and reproducible foundation for improving pediatric patient safety in compounding.
• ExcipioForm serves as a decision-support tool to mitigate risks and standardize compounding practices, enhancing clinician judgment.