Selection of Granulation Process for Solid Dosage Form
Selecting the right processing platform for solid dosage forms is essential for ensuring product quality, efficacy, and manufacturability. This decision-guiding flowchart provides a structured approach to choosing the best processing method based on key formulation parameters.
Key Considerations:
1. Solubility: The Biopharmaceutics Classification System (BCS) class determines solubility. For Class II & IV compounds, solubility enhancement techniques like particle size reduction and water-soluble excipients may be needed.
2. Dose: Low or high dose affects the approach. High doses often require assessment of the API’s flow and mechanical properties to prevent manufacturing issues.
3. Blend Segregation Potential: For low-dose formulations, it’s crucial to consider blend homogeneity and the risk of segregation during processing.
4. API Sensitivity: If the API is moisture and/or heat-sensitive, dry granulation might be preferable over wet granulation.
Pathway to Processing:
- Direct Compression: When the API is stable and there’s low risk of segregation.
- Dry Granulation: Suitable for sensitive APIs that cannot tolerate moisture or heat.
- Wet Granulation: When good API flow and stability support the wetting process.
This flowchart serves as a quick reference to help formulation scientists navigate the initial stages of selecting an optimal processing method for a target product profile (TPP). Simplifying the decision-making process enables efficient development of robust formulations.
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