Module 3 Presentations

07/05/2024

Factors affecting Physical Drug Product Stability

• Polymorphs • Polymorphic transition

• Hydrate/solvate formation • Dehydration/desolvation • Crystallization of amorphous materials

• Particle size/surface area • Other quality attributes • Resuspendibility • Aggregation

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Physical modifications

Stability affecting physical processes ● change of crystal structure ● change of texture respectively the state of aggregation

● modification of the solubility conditions ● modification of the hydration conditions

Consequences of physical modifications ● change in physical properties

– decrease in hardness, breaking strength – increase of abrasion (friability) – change of release properties – change of color properties

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