1. Influence on Stability

• Moisture Sensitivity: Smaller granules have a larger surface area, which can increase moisture absorption, leading to hydrolytic degradation of moisture-sensitive drugs.

• Oxidation: Increased surface area also accelerates oxidative degradation. Larger granules are relatively more stable in such cases.

• Flow Properties: Properly sized granules improve powder flow during compression, reducing variability and segregation. Poor granule size distribution can lead to inconsistent tablet weight and drug content.

• Physical Stability: Finer particles may cause capping, lamination, or hardness variation due to poor compressibility, affecting long-term stability.

2. Influence on Bioavailability

• Dissolution Rate: Smaller granules dissolve faster because of higher surface area, which enhances drug dissolution rate and bioavailability—important for poorly soluble drugs (BCS Class II & IV).

• Uniformity of Dosage: Optimal granule size ensures uniform distribution of active pharmaceutical ingredient (API), preventing dose variation and ensuring consistent therapeutic effect.

• Disintegration: Appropriate granule size promotes better tablet disintegration, aiding rapid drug release and absorption. Too large granules may delay disintegration and reduce absorption rate.

• Controlled Release: In sustained-release formulations, controlling granule size helps regulate release kinetics, ensuring predictable plasma drug levels.

✅ Summary:

• Smaller granules → Faster dissolution, higher bioavailability, but more prone to instability.

• Larger granules → Better stability, slower dissolution, may lower bioavailability.

• Optimal granule size distribution is essential to balance stability and bioavailability in tablet formulations.

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