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Preformulation
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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).
Physicochemical tests conducted during prenomination and lead optimization enable rational decisions for compound, salt or polymorph selection that maximize the probability of compound success and are essential to the establishment of a sound intellectual property position. 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 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 go from there. Working together in this way ensures the best chance of drug candidate success.
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