Modeling moisture change of packaged dry tablet dosage forms under consumer use condition

Area of Science:

• Materials Science
• Chemical Engineering
• Food Science

Background:

• Determining the in-use shelf life (ISL) of dry solid products is crucial for maintaining quality.
• Consumer handling, involving product removal, significantly impacts internal product moisture levels.
• Existing methods for ISL determination often lack precision, necessitating advanced predictive tools.

Purpose of the Study:

• To develop and validate a mathematical model for predicting moisture content in dry solid tablets during consumer use.
• To establish a science-based approach for accurate ISL determination.
• To provide a tool for optimizing product packaging and management strategies.

Main Methods:

• Developed a mathematical model integrating product moisture sorption isotherms and package moisture transmission.
• Incorporated a mass balance equation accounting for the amount of product remaining in the package.
• Validated the model using literature data (desiccant canisters) and experimental data (refresher candies) under various environmental conditions.

Main Results:

• The model accurately predicted moisture content in dry solid tablets under simulated in-use conditions.
• Validation against literature data (desiccants) and experimental data (candies) confirmed model efficacy.
• The model demonstrated capability in predicting moisture changes at 76% and 90% relative humidity.

Conclusions:

• The developed mathematical model offers a reliable method for predicting in-use moisture content in dry solid products.
• This model facilitates accurate, science-based determination of in-use shelf life (ISL), serving as a consumer guideline.
• The model is valuable for recommending product management schemes throughout the entire product lifecycle.