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Solid oral dosage forms

Solid Oral Dosage Forms

Beyond-Use Date (BUD) Prediction

Explainable estimation of the beyond-use date for tablets, capsules, and powders based on the API’s molecular descriptors, formulation characteristics (excipients, assay), environmental parameters (temperature, humidity), and packaging, leveraging published stability data.

What is this module for?

Scientifically justify the beyond-use date (BUD) for solid preparations; optimize the formulation by quantifying the impact of excipients and storage conditions; document decisions with an exportable report (PDF/CSV) and a ranking of influential factors.

Inputs

Dosage form characteristics and % API (assay); key excipients and formulation variables (e.g., moisture, viscosity where applicable); packaging (material, barrier) and environmental parameters (temperature, humidity).

Outputs

Predicted beyond-use date (BUD) with a confidence interval; analysis of influential factors (formulation, packaging, environment); exportable report for traceability and pharmaceutical justification.

Worked examples

Simple case
Standard parameters (known formulation, controlled temperature) → direct BUD prediction.
Advanced case
Specific constraints (high humidity, critical excipient) → analysis of influential factors.
Alternative packaging
Assessing the impact of changing material/barrier on beyond-use date.

Limits & precautions

Applicability domain constrained by available stability data; extreme conditions or outside the training space → increased uncertainty requiring experimental confirmation.

FAQ

Can the model predict if a parameter is missing?
In some cases, yes. The model can estimate the beyond-use date from available variables; however, the confidence interval may widen. Supplying as much information as possible improves robustness.
How should I interpret a wide confidence interval?
A wide interval reflects higher data variability or incomplete information (excipients, humidity, pH, packaging). Refining inputs or confirming with targeted stability studies is recommended.
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⚠ Warning – Demonstration Module
This interactive tool is an experimental prototype developed in KNIME and provided solely for demonstration and training purposes. The results displayed (predicted Beyond-Use Date, influential factors analysis, etc.) are indicative and are not validated for clinical or regulatory use. They do not replace stability studies, official standards (Ph. Eur., USP, ICH), nor the internal procedures of any healthcare institution. The data must not be used as the sole basis for determining an actual Beyond-Use Date. Any interpretation must be carried out under the responsibility of a qualified pharmacist.