Application of ICH Q9 Quality Risk Management Tools for Advanced Development of Hot Melt Coated Multiparticulate...

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Quality Risk Management

Background:

• Early-stage development of multiparticulate systems requires robust quality control.
• The International Conference on Harmonisation guideline Q9 provides a framework for quality risk management.
• Hot melt coating is a key process for modifying drug release and masking taste.

Purpose of the Study:

• To apply quality risk management (QRM) principles to the early development of hot melt coated multiparticulate systems.
• To identify and control critical quality attributes (CQAs) and critical process parameters (CPPs).
• To enhance product development sustainability and regulatory compliance.

Main Methods:

• Utilized failure mode and effects analysis (FMEA) for CQA prioritization.
• Employed process FMEA and design of experiments (DOE) to identify and confirm CPPs.
• Applied hazard and critical control points (HACCP) analysis for control strategy definition.
• Conducted fault tree analysis (FTA) to evaluate potential process failures.

Main Results:

• Defined CQAs: particle size, taste-masking efficiency, and immediate release profile.
• Identified CPPs: spray rate, atomization air pressure, and air flow rate.
• Identified critical material attributes: coating amount and polysorbate 65 content.
• Established control strategies at critical process points.

Conclusions:

• A standardized QRM approach effectively optimizes the development of hot melt coated systems.
• This methodology supports regulatory aspects and enhances product development sustainability.
• The study demonstrates the successful application of ICH Q9 principles in pharmaceutical development.