In the current economic climate more and more pharmaceutical companies are recognising the need to optimise the physical form of their new candidate drugs and try to ensure that they maximise their intellectual property (IP) at the same time. The polymorphic form of a solid substance, including most drugs, is patentable and it is theoretically possible to find a new polymorphic form of an existing drug and patent it. If the new polymorphic form has advantageous properties over the existing product on the market, it can, in principle supersede the earlier product. Moreover, if a new polymorphic form suddenly appears (it does happen), it may have properties that are inconsistent with its current formulation. One polymorphic form may be more biologically available than its predecessor or it may be less biologically available. Either way, a lot of money may have been wasted developing a particular polymorph. Recent examples show that it can be very costly if the physical form is not controlled but the pharmaceutical industry has not yet fully embraced this aspect of drug development.
So what is polymorphism? It is simply a different arrangement a molecule might adopt in a crystal. Most drug molecules are crystalline. That is, the molecules pack together in a particular 3 dimensional way. Some molecules, perhaps most, are able to pack together in more than one way and give rise to different polymorphs. A pair of polymorphs might have very different physical properties. It is the skill of the chemist, employed during the process development of the drug, that ensures the desired polymorph is consistently made. Another type of chemist, employed to research the possible variations on polymorphism, could also be extremely effective in ensuring that all bases are covered from an IP perspective.
These days, we all need to keep an eye on the bottom line. Perhaps if your company was to cast an eye over the other lines as well and make use of specialists in
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