A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms

Area of Science:

• Pharmaceutical Sciences
• Chemical Engineering
• Materials Science

Background:

• Current methods for selecting drug manufacturing routes lack a standardized risk assessment framework.
• Pharmaceutical development requires robust tools to predict product developability and processability.

Purpose of the Study:

• To propose and develop a Manufacturing Classification System (MCS) for drug products based on processing routes.
• To establish a common understanding of risk in pharmaceutical development by defining critical material attributes.
• To aid in selecting the most suitable manufacturing process and facilitate technology transfer.

Main Methods:

• Summarizing conclusions from an APS conference and working group discussions.
• Developing a system to rank processing route feasibility based on API properties and formulation requirements.
• Soliciting stakeholder input on critical API properties for efficient manufacturing.

Main Results:

• The proposed MCS aims to predict product developability and processability.
• It provides a framework for defining "right particles" for optimal manufacturing.
• The system is designed to enable better process selection and aid in manufacturing transfer.

Conclusions:

• The Manufacturing Classification System (MCS) offers a novel approach to optimize drug product development.
• Further stakeholder collaboration is crucial for refining and implementing the MCS in pharmaceutical practice.
• The MCS has the potential to improve efficiency and robustness in pharmaceutical manufacturing.