Unit 2: Preformulation Studies
Preformulation studies involve evaluating the physicochemical properties of an API to predict formulation challenges and guide dosage form design. These studies include moisture analysis, solubility, hygroscopicity, and compatibility assessments critical for stability and manufacturability.
Definition
Preformulation studies are the initial phase of drug development that involves investigating the physicochemical properties of an API to design an optimal dosage form.
These studies help identify potential formulation challenges such as solubility, stability, and compatibility with excipients. Preformulation data guides dosage form selection and process design.
Key Points
Determines API characteristics before formulation
Includes solubility, hygroscopicity, particle size, and solid-state properties
Critical for predicting stability and manufacturability
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