- Particle size and shape are critical physical parameters in pre-formulation studies that significantly influence the behavior and performance of pharmaceutical dosage forms.
- Particle size and shape determine the surface area, flowability, dissolution rate, and bioavailability of a drug, making them critical factors in pre-formulation and product design.
Particle Size:
Definition:
- Refers to the diameter or dimension of individual drug particles.
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Importance:
- Dissolution Rate: Smaller particles have a larger surface area, enhancing dissolution and absorption.
- Uniformity: Ensures consistent dosing in tablet or capsule formulations.
- Flow Properties: Poorly sized particles may lead to aggregation and poor flow, impacting manufacturing efficiency.
- Bioavailability: Influences drug absorption, especially for poorly soluble drugs.
Example:
- Micronization reduces particle size to improve the solubility of drugs like griseofulvin and fenofibrate.
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Particle Shape:
Definition:
- Describes the geometric form of particles (e.g., spherical, irregular, needle-shaped).
Importance:
- Flow Properties: Spherical particles flow better than irregular ones.
- Packing Density: Impacts compression characteristics during tablet manufacturing.
- Dissolution Rate: Shape can influence the effective surface area exposed to the solvent.
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