The primary goals of pre-formulation studies are:
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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.
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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.
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Optimize Drug Delivery:
- To determine the appropriate delivery method (e.g., oral, injectable, topical) based on drug properties like solubility and permeability.
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Ensure Stability and Compatibility:
- To evaluate how the drug interacts with environmental factors (e.g., heat, light, moisture) and excipients, ensuring long-term stability.
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Enhance Bioavailability:
- To study the solubility, dissolution rate, and absorption potential of the drug, ensuring it can be effectively absorbed by the body.
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Regulatory Compliance:
- To gather data required for regulatory submissions, such as Investigational New Drug (IND) applications.
-
Minimize Development Costs:
- To avoid failures during later stages of formulation development by identifying potential issues early.
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