Preformulation
Drug preformulation services, customized to your specific needs.
Physiochemical tests conducted during candidate prenomination and lead optimization enable rational decisions for compound salt or polymorph selection that maximize the probability of compound success and are essential to establishment of a sound intellectual property position.
During the preformulation phase, most people understand the importance of setting chemical specifications and addressing chemical stability, but many fail to understand the importance of assessing physical properties of their active pharmaceutical ingredient (API).
Salt forms with advantageous physical properties are patentable as new chemical entities, and knowledge of the potential existence of multiple salt forms may help to strengthen a patent by including other forms in the application.
When outsourcing drug preformulation work, it is important to consider a provider that offers more than a pre-defined set of solutions. A good contract research organization will work to understand the product development goals, the physical and chemical properties of the compound itself, put this in the context of your budget, and create a preformulation strategy that addresses each of these aspects. Working together in this way ensures the best chance of drug candidate success.
Excellent preformulation testing will come only after careful consultation with a client regarding their exact needs. Xcelience can carefully tailor the results of the testing to include only those readings and results that will be important to the specific dosage being used in the preformulation study.
Xcelience drug preformulation services include solid state characterization, solution characterization, excipient compatibility, accelerated stability, chiral stability and X-ray diffraction (XRD).
Click on the links below to get more information our preformulation offerings in each of these areas, or click on “get a solution” above to contact one of our experts who can reach out to you about your specific preformulation needs.
