Every material has intrinsic chemical and physical properties which to be considered before development of pharmaceutical formulation. From this aspect preformulation study is required for characterization of API and excipients used in the formula.
Preformulation study is a group of studies to determine the characteristics of active substance and/or excipients that may influence the formulation, process design and drug performance.
Following Parameters to be checked or measured as a Preformulation Study of a new Generic Drug Product
Physical characterization
- Pharmacopoeial status (BP/USP/JP/INN)
- Molecular formula
- Molecular weight
- Chemical structure
- CAS number
- BCS class (I/II/III/IV)
- OEL / OEB
- pKa value
- Appearance
- Polymorphism (Crystal, Amorphous etc.)
- Solubility
- pH solubility study (1.2, 4.5, 6.8)
- Particle size distribution
- Density (Bulk & Tapped)
- Microscopic observation
Chemical Characterization
- Assay
- Stressed Analysis
- Degradants (Expected)
- Hygroscopicity
- Melting point
- XRD / DSC
- Impurity profile (Organic, Elemental etc.)
- Optical rotation
- Enantiomeric purity
- Residual Solvents
- Others (if required)
Importance of Preformulation Studies
In pharmaceutical drug product development, preformulation study play a vital role to optimize the formula and process. When a preformulation study completed successfully and find out details about the API and excipients used in the formula, it’s become easier to identify the CMA, CPP & CQA of the product.
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