Module 3 Presentations

07/05/2024

Solid State Properties  Majority of candidates are solids at room temperature  Typically properties include:  Surface area  Particle size distribution  Hygroscopicity  Polymorphism  Solid state stability  Intrinsic dissolution rate  Used for the development of solid dosage forms

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

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Solution Properties  Describe the solution properties of the compound  Typical studies:  Association and dissociation constants  Complexation constants  Solubility as function of pH  Solubility in selected solvents  Partition coefficients as a function of pH  Solution stability  Used for development of solution dosage forms and understanding its pharmacological behaviour

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

14