- Introduction to Pre formulation studies involve the investigation of physical and chemical properties of a drug to develop safe, effective, and stable dosage.
- Introduction to Pre-formulation: Aims to develop stable and effective dosage forms.
Definition of Pre formulation studies:
- Pre-formulation is the initial phase in the drug development process that involves the comprehensive characterization of a drug substance’s physical and chemical properties.
- This stage precedes formulation development and aims to inform and guide the subsequent steps in creating a stable, effective, and manufacturable pharmaceutical product.
Purpose:
- To gather essential data on the drug substance.
- To identify potential challenges in formulation and manufacturing.
- To select appropriate excipients and processing methods.
- To ensure the drug’s stability, bioavailability, and efficacy.
Scope of Introduction to Pre-formulation:
- Pre-formulation encompasses various study, including solubility, stability, crystallinity, polymorphism, and other physicochemical properties that influence the drug’s behavior during formulation and storage.
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