Physicochemical Studies

There is universal recognition that the physicochemical properties of the API are usually key to its behaviour when formulated as well as its bioavailability in-vivo. The API physical properties are defined and significantly affected by the unit operations in the final isolation step.

RML Pharma Consulting can provide the following services:

  • Review the physicochemical data for the current salt/polymorph of API and provide an assessment of the long term developability.

      • If your current salt/polymorph has issues (eg solubility, stability, crystallinity, bioavailability) then we can coordinate a salt and polymorph screen, review the data and identify potential back-ups.

          • Review the formulation strategy and consider the potential impact of the physicochemical properties of the API on the performance of the drug product.

              • Coordinate and manage a program of work aimed at developing a final stage crystallisation to control API physical properties.
                • RML Pharma Consulting can provide all of these services as part of an outsourcing campaign at contract or we can provide a more tailored approach to support your projects in-house.