01/02/2025
Why Particle Size Distribution (PSD) Matters in Oral Solid Dosage Forms
In pharmaceutical manufacturing, particle size distribution (PSD) plays a critical role in ensuring the quality, efficacy, and performance of oral solid dosage forms (OSDs) like tablets and capsules. Here's why it matters:
• Dissolution & Bioavailability - Smaller particles increase surface area, enhancing dissolution and drug absorption, especially for poorly soluble APIs.
• Content Uniformity - A consistent PSD prevents dose variations, ensuring uniform distribution of the active ingredient.
• Flowability & Compressibility - Optimized PSD improves powder flow, reducing segregation and enabling efficient tablet compression.
• Granulation & Blending Efficiency - Helps in achieving uniform granules, improving formulation consistency.
• Stability & Shelf Life - Reducing particle size variability prevents segregation, caking, and physical instability over time.
• Disintegration & Release Profile - Controlled PSD
ensures predictable drug release, crucial for immediate
and controlled-release formulations.
• Manufacturing Optimization - Understanding PSD
aids in selecting the right milling, granulation, and compression techniques for better product quality. From R&D to large-scale production, PSD is a key factor in developing robust and effective pharmaceutical products.