Crystal Pharmatech’s deep understanding of the solid state allows us to design solubility and dissolution experiments carefully considering variables such as supersaturation and solid form conversion.  Besides measuring a concentration, understanding changes in the solid phase is extremely important for an accurate solubility measurement.

Even though dissolution and solubility are terms closely related, they are different. Dissolution is the measurement of the concentration in solution over time and very frequently the dissolution is accompanied by form changes. Understanding the dissolution of solid forms (API, tablets, suspension, amorphous solid dispersion) in aqueous media is very important to select the right API form and dosage form.

In addition, understanding precipitation, the reverse process, is very important to assess the performance of solution formulations.  Dilution of a solution formulation in gastric fluid are commonly associated by generation of supersaturation followed by precipitation, the “speed” as well as the form that precipitates can affect the performance of the formulation.

Benefits of our solubility determination and dissolution services include

Solubility and Dissolution (Precipitation) in Biorelevant media (SGF, FaSSIF, FeSSIF)

     •     Understanding dissolution/precipitation profile throughout the GI tract

     •     Selecting the right API form

     •     Designing robust formulations

Solubility at several pHs

     •     Designing robust aqueous formulations

     •     Designing reliable crystallizations

     •     Designing robust analytical methods (HPLC)

Solubility in Non- Aqueous and Aqueous Vehicles

     •     Designing robust formulations in cyclodextrins, micellar and lipidic solutions

     •     Enabling formulations with enhanced bioavailavility.

     •     Solving the poor bioavailability of “brick dust” or “grease balls”.

Solubility in organic solvents

     •     Providing reliable API crystallizations by selecting the right solvent composition and process.

     •     Planning efficient salt screening and polymorph screening.

         •     Designing robust formulations processes such as amorphous solid dispersions.