Solubility

Pion's Miniaturized Shake-Flask Method is a quick, affordable, API-Sparing way providing equalibrium solubility for compound over a range of pHs in a variety of different media.

 

SOLUBILITY SCREENING:

 

Solubility by Miniaturized Shake Flask, µSOL Method (DMSO solutions)

Pion’s patented µSOL assay for solubility determination is applied to a compound in aqueous buffer. UV, LC or LCMS detection available. Compounds submitted as 10mM DMSO solutions (250µL).  API in formulations or excipients is also possible and requires analysis of both the API and placebo.              

 

 

Solubility by Miniaturized Shake Flask Method (DMSO Free)      

The shake flask assay for solubility determination is applied to a compound in one aqueous buffer. UV, LC or LCMS detection available. Compounds submitted as pre-weighed solids.  API in formulations or excipients is also possible and requires analysis of both the API and placebo.                

 

 

SOLUBILITY MONITORING:

 

Supersaturation & Kinetic Solubility

API solubility as a function of time is performed using in situ measurement or off-line LC or LCMS analysis.                                        

Different salts, polymorphs or API preparations can be analyzed to provide a comprehensive solubility characterization of a drug substance.

 

Formulation analysis can be done for an API in:

  • Different formulations
  • Blends (Excipients/Placebos)
  • Micro and Nano-suspensions
  • Multicomponent Systems                      

 

Dynamic Media Change Solubility

API or formulations can be studied as the dissolution media transitions from a simulated gastric composition to that of a FeSSIF or FaSSIF state.  Analysis by in situ monitoring instrumentation as well as off-line LC or LCMS is available.  Dynamic pH studies can also be designed around a customer's specific needs.                        

                             

THERMODYNAMIC SOLUBILITY:

 

Solubility in Pure Solvents

Traditional shake flask solubility determination of pure API in one media is performed using a defined load.  UV, LC or LCMS detection is available.

 

Intrinsic Dissolution Rate:

 

Pressed pellets or loose powders are placed in dissolution media.  The concentration is measured in time by in situ monitoring instrumentation for maximum data density.  Compounds are submitted as powders and samples run in duplicate.  Small volume and large volume format available.