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Jump to Services NavigationPreformulation Package
According to the Product Quality Research Division of the FDA, the
goal of preformulation is to:
“investigate critical physicochemical factors which assure identity, purity of drug substances, formulatability, product performance and quality.”
Preformulation studies have a significant part to play in anticipating
formulation problems and identifying logical paths in both liquid and solid
dosage form development.The PI CIC offers a complete preformulation
Package that is tailored to the requirements of the client.
Typically our preformulation package consists of the following :
Solubility, pH, solution stability
Moisture content, sorption analysis
Thermal analysis (thermal behavior, melting point)
Structural characterization—FTIR, UV/Vis, fluorescence, NMR, MSn
Particle morphology, size and size distribution
X-ray powder diffraction (XRPD)
Polymorph and salt screening
Solid state and solution stability
Drug-excipient compatibility and packaging component compatibility
Compressibility studies
Solubility
To develop a pharmaceutically acceptable drug, solubility in aqueous fluids greatly
influences the rate and extent to which drug is absorbed from a number of routes of
administration. The solubility of a compound in pharmaceutical vehicles also dictates the
ease to which a formulation can be developed.
pKa
Determination is essential during solubility profiling as it allows the informed use of pH
to maintain solubility and choose salts if required to achieve good bioavailability from
the solid state and improve stability and powder properties
Partition Coefficient
The partition coefficient (logP) or distribution coefficient (logDlogD) is a measure of
partition between two immiscible solvents. The solvents are usually water and
octanol. Hence, both the partition and distribution coefficients measure how
hydrophilic (water loving) or hydrophobic (water hating) a chemical substance is.
This can provide information to help in predicting membrane permeability, tissue
distribution and affinity for pharmacological targets.
