Parenteral and Ocular Dosage Forms
Prediction of Beyond-Use Date (BUD)
Explainable estimation of the beyond-use date for solutions and suspensions intended for parenteral or ocular administration, based on the molecular descriptors of the API, the formulation characteristics (pH, osmolarity, solvent, preservative), the packaging (glass, plastic, filter, syringe), and the environmental parameters (temperature, light, sterilization), using published stability data as the scientific basis.
What is this module for?
This module helps to scientifically justify the Beyond-Use Date (BUD) of parenteral and ocular preparations, to optimize formulation by considering sterilization, material compatibility, and chemical stability, and to document pharmaceutical decisions through an exportable report (PDF/CSV) including the ranking of influential factors.
Input Data
The parameters to be entered include the pharmaceutical characteristics and API concentration, the formulation parameters (pH, osmolarity, viscosity, preservative, solvent), as well as the packaging (syringe, vial, filter, material) and the environmental parameters (temperature, exposure, sterilization).
Outputs
The module provides a predicted beyond-use date (BUD) with a confidence interval, an analysis of influential factors (effect of pH, temperature, packaging, sterilization), as well as an exportable report for traceability and pharmaceutical justification.
Example Cases
Sterile aqueous solution with controlled pH and standard packaging → direct BUD prediction.
Concentrated solution with extreme pH or excipients sensitive to sterilization → detailed analysis of destabilizing factors.
Comparative study: vial vs prefilled syringe, with or without filter.
Limitations & Precautions
The applicability domain of the model is limited to sterile dosage forms covered by published data. Under extreme conditions (pH or osmolarity outside typical ranges, new materials), increased uncertainty may occur, requiring additional experimental validation.