TROUBLE SHOOTING GUIDE |
Granulation & Tablet Compression
Abstract: This troubleshooting guide provides a structured approach for resolving common issues encountered in pharmaceutical
granulation and tablet compression. It is intended for R&D, MS&T, and production teams across product development, scale-up, and commercial manufacturing.
The guide outlines critical process parameters (CPPs) and critical quality attributes (CQAs) for wet granulation, dry granulation, direct compression, and tablet compression. For each step, typical issues are linked to likely root causes, with recommended corrective actions categorized into process adjustments, formulation modifications (Level 1: excipient grade or supplier changes), and reformulation strategies (Level 2).
Special focus is given to challenges with low-dose and highdose APIs, segregation risks, and chemical stability considerations. Recommendations for MEGGLE excipients are provided throughout, highlighting their functional advantages in different processes. The guide aims to support systematic problem-solving, improve robustness in manufacturing, and facilitate life-cycle management of solid oral dosage forms.
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