Solid state properties – salts, polymorphs, co-crystals, hydrate, solvates and amorphous forms.
The packing of an API in the solid state can be of huge importance for the processing, stability and use of pharmaceutical products. Furthermore regulatory authorities around the world, such as the FDA and EMEA, require the study of physical form for product registration.
This field is an important area to study for problem solving and is very often the cause of batch-to-batch and supplier-to-supplier variability. Professor Buckton has consulted on this subject with many companies across the world and has worked as an expert witness on a number of patent cases relating to physical form.
During his time as CEO Graham established Pharmaterials as one of the leading companies for contract work in salt selection, polymorphism screening, co-crystal formation and amorphous materials use and testing. The experience of working on many APIs each and every month over a number of years allows Graham to assist you with your physical form questions and challenges.
The question of when to study physical form and how much work to do at different stages in development is a tricky one for companies to deal with and it is important to make the correct decisions for the API that you are working with. Professor Buckton can provide advice and assist with interpretation of data and selection and management of outsourcing companies.
Having spent many years serving on MHRA committees Graham is familiar with the extent to which physical form should be studied in order to satisfy a regulator that a product is of suitable quality.