Development of an automation system for a tablet coater

Area of Science:

• Pharmaceutical technology
• Process engineering
• Materials science

Background:

• Tablet film-coating is crucial for drug delivery and stability.
• Traditional monitoring methods lack precision, impacting reproducibility.
• Automated systems offer enhanced control over critical process parameters.

Purpose of the Study:

• To design and validate an automated pan-coating system with novel airflow measurement.
• To monitor and analyze critical process parameters during tablet film-coating.
• To assess the impact of airflow on coating quality and process reproducibility.

Main Methods:

• Development of an instrumentation and automation system for a side-vented pan coater.
• Continuous monitoring of thirteen process parameters, including a novel airflow rate measurement.
• Validation using over 20 pilot-scale batches of hydroxypropyl methylcellulose (HPMC) coated tablets.
• Surface roughness analysis using laser profilometry.

Main Results:

• The automated system provided comprehensive, quantitative data on monitored parameters.
• Coating process reproducibility was confirmed through analysis of process parameters and tablet responses.
• Inlet airflow rate significantly influenced coating quality, with high rates causing defects and increased material loss.
• Increased airflow accelerated tablet surface drying, impacting final coating quality.

Conclusions:

• The instrumented and automated pan-coating system is a valuable tool for controlling and characterizing tablet film coating.
• Monitoring critical process parameters, especially airflow, enhances coating process efficiency and predictability.
• The system's historical data storage aids in process optimization and quality assurance.