QbD-based Development for the Compression Process of Trimebutine Maleate Tablets

Key Points

• The study aims to propose a model for developing the compression process of Trimebutine Maleate tablets using a Quality by Design (QbD) approach.
• Established product quality target profile (QTPP) in the first step.
• Designed the amounts of active pharmaceutical ingredients in tablet formulation and established processes for mixing, granulating, and compressing.
• Identified critical quality attributes (CQAs) for the products, such as dissolution and hardness.
• Conducted risk assessments to evaluate the impact of compression parameters on CQAs, identifying critical process parameters (CPPs).
• Developed control strategies based on the evaluation of product quality against varying CPPs.
• Defined CQAs included dissolution, content uniformity, hardness, and weight variation.
• Identified compression pressure and speed as critical process parameters impacting CQAs.
• Established control strategies for managing tablet quality based on findings.
• Demonstrated the applicability of the QbD approach in the regulatory framework.

Abstract