Selecting the right manufacturing process for tablet dosage forms is a critical decision influenced by multiple factors, including API content, bioavailability challenges, and patent constraints. Here’s a structured approach:
API Strength & Content:
- High-dose APIs (e.g., >30-40% w/w): Often suitable for direct compression (DC) if the API has good flow and compressibility. If not, roller compaction (dry granulation) or high-shear granulation (wet granulation) can be employed.
- Low-dose APIs (<5% w/w): Require uniform distribution, often achieved through high-shear wet granulation (RMG) or fluid bed granulation (top-spray granulation) to improve blend homogeneity.
Bioavailability Enhancement:
- Poorly soluble APIs: Technologies like spray drying (SD) and hot-melt extrusion (HME) can enhance solubility and dissolution rates. These techniques are particularly effective for BCS Class II and IV drugs.
Regulatory & Patent Considerations:
- Selection of excipients and process parameters must be strategically planned to ensure non-infringement of existing patents while maintaining formulation performance.
- Exploring 505(b)(2) pathways for innovative process-based differentiation can provide a competitive advantage in regulated markets like the USA.
A strategic approach to process selection ensures not only manufacturability but also compliance with regulatory and intellectual property landscapes.
Read also: Advanced Granulation Techniques
Resource Person: Ashish Makwana
