Defination, objective, Goal and Area of Pre-formulation study of Tablet
Definition
Investigation of physico chemical properties of the new drug compound that could affect drug performance and development of an efficacious dosage form.
Objective
- To establish its compatibility with common excipients.
- To determine its kinetics and stability.
- To establish the physico chemical parameters of a new entity.
- To increase drug stability
- To improve drug bioavailabilty.
Goal
- To establish physical characteristics.
- To determine kinetic rate profile.
- Develop a stability indicating assay.
- Establish drug compatibility with common excepients.
Area of preformulation
- Organoleptic Characters
- Bulk Characters
- Crystallinty and polymorphism
- Hygroscopicity
- Fine particle characterization
- Powder flow properties
3. Solubility Analysis
- Ionization constant PKa
- pH solubility profile
- Common ion effect Ksp
- Thermal effects
- Solubilization
- partition co - efficient
- Dissolution
4.Stability Analysis
- Stability in toxicology formulations
- Solution Stability
- pH rate profile
- Solid state stability
- Bulk stability
- Compatibility
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