Oral Liquid Dosage Forms
Prediction of Beyond-Use Date (BUD)
Explainable estimation of the beyond-use date for oral solutions and suspensions based on the molecular descriptors of the API, the formulation characteristics (e.g. solvents, preservatives, viscosity), the environmental parameters (temperature, light/oxidation), and the packaging, using published stability data as a scientific foundation.
What is this module for?
This module helps to scientifically justify the Beyond-Use Date (BUD) of oral liquid preparations, to optimize formulation (choice of solvent, preservative, pH or viscosity adjustment) by quantifying their effects, and to document the decision-making process through an exportable report (PDF/CSV) including the ranking of influential factors.
Input Data
The required input variables include the pharmaceutical characteristics and API content (% API), the key excipients and formulation parameters (pH, solvent, preservative, viscosity), as well as the packaging (material, color) and environmental parameters (temperature, exposure to light).
Outputs
The module provides a predicted beyond-use date (BUD) with a confidence interval, a ranking of influential factors (pH, solvent/preservative, packaging, temperature, etc.), and an exportable report to support traceability and pharmaceutical justification.
Example Cases
Aqueous solution with controlled pH and appropriate packaging → direct BUD prediction.
Viscous suspension with critical pH or specific solvent → detailed analysis of influential factors.
Evaluation of the impact of a change in material/color/closure on the beyond-use date.
Limitations & Precautions
The applicability domain of the model depends on the available stability data for oral liquids. Under extreme conditions (pH, oxidation, or viscosity outside typical ranges), higher uncertainty may occur, requiring experimental confirmation.