Process Development

• 3.2 Process Development

3.1.1 Pre-formulation Studies

• Key Activities: Solubility analysis, particle size characterization (laser diffraction), and excipient compatibility testing (DSC/TGA).

• Purpose: Identify optimal API forms (polymorphs, salts) and predict stability challenges for robust formulation design.

3.1.2 Formulation Design

• Solutions: Develop tablets, capsules, injectables, or topical products using QbD (Quality by Design) principles.

• Technologies: Hot-melt extrusion, nanoemulsions, and sustained-release matrices for enhanced bioavailability.

• Compliance: Align with ICH Q8 guidelines for design space definition and critical quality attributes (CQAs).

3.1.3 Stability Testing

• Protocols: ICH Q1A (R2)-compliant accelerated (40°C/75% RH), intermediate, and long-term studies.

• Analytics: Monitor potency, degradation products (HPLC), and physical stability (dissolution, pH) over shelf life.

• Outcome: Establish expiry dates and storage conditions for global regulatory submissions.