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.