The primary goals of pre-formulation studies are:
Understand the Drug’s Characteristics:
To determine the physical and chemical properties of the drug substance.
To understand how these properties influence the drug's performance, stability, and compatibility.
Support Formulation Development:
To guide the selection of excipients, processes, and packaging materials for dosage form development.
To identify and mitigate any formulation challenges early in development.
Optimize Drug Delivery:
To determine the appropriate delivery method (e.g., oral, injectable, topical) based on drug properties like solubility and permeability.
Ensure Stability and Compatibility:
To evaluate how the drug interacts with environmental factors (e.g., heat, light, moisture) and excipients, ensuring long-term stability.
Enhance Bioavailability:
To study the solubility, dissolution rate, and absorption potential of the drug, ensuring it can be effectively absorbed by the body.