Characterization - small molecules

Physicochemical characterization of small molecular drug compounds

Solubility and stability of new drug candidates may sound trivial to do in discovery, but nevertheless are disciplines that are often neglected or given low priority. Frequently these parameters will not be addressed until unsatisfactory absorption has been experienced in animal studies, thus delaying or even stop further development of a promising new drug candidate.
Bioneer:FARMA will in collaboration with the client customize an experimental plan that will  address the  solubility and stability issues and identify possible obstacles in the absorption of the compound. Together with an in-depth evaluation other physico-chemical properties for the compound this (tailormade) experimental plan will also provide the information necessary to define a formulations strategy for the compound. A non-exhaustive list of experiments covered by Bioneer:FARMA is shown below.

Classification of your compound in the Biopharmaceutics Classification System (BCS)

Equilibrium solubility:
Intrinsic solubility
pH dependent solubility
Solubility in excipients

Log D and pKa determinations:
GLpKa-meter
HPLC

Dissolution
Intrinsic dissolution (rotating disc)

Chemical stability assessment
In buffers and/or biorelevant media

Salt selection and solid state characterization:
X-Ray Diffraction (XRPD)
Differential Scanning Calorimetry (DSC)
Elementary analysis
Thermometric Gravity Analysis (TGA)
Particle size distribution
Infrared Spectroscopy (IR)
RAMAN spectroscopy

For further information, please contact head of Bioneer:FARMA, Anette Müllertz by phone (+45 45160444) or email.