*1.7.9 Generation/extension of intellectual property*

Intellectual property (IP) is vital for pharmaceutical companies. The intellectual property (IP) protection of new ideas, inventions, processes or products grants exclusivity over the manufacturing process and products. Patents, copyright and trademarks, for example, are legal mechanisms that allow individuals or organizations/ companies to gain recognition or financial benefit from their work or investment in a creation. A total of 138 patents are granted to recognize an invention that meets the criteria of global novelty, non-obviousness and industrial application. Pharmaceutical

### *Modification of Physicochemical Properties of Active Pharmaceutical Ingredient… DOI: http://dx.doi.org/10.5772/intechopen.110129*

companies must deal with drug or drug product patent life cycle management to keep their pharmaceuticals on the market for as long as possible. Screening of novel solid dosage forms of marketed drugs, such as polymorphs, salts and co-crystals, provides the opportunity to grant new IP and extend the patent life cycle of those drugs. Pharmaceutical co-crystals have regulatory and intellectual property advantages that provide them with unique possibilities, benefits and challenges. From a regulatory standpoint, drugs containing a novel co-crystal are considered similar to a new polymorph of the API. This guidance takes novel co-crystals to be considered as a new drug substance, which promotes their independent patentability as novel solid forms [129].

#### *1.7.10 Melting point*

Melting point is the physical property of solids, which is used to determine the purity of the product [130]. The high melting point of the new materials demonstrates their thermodynamical stability; that is, the thermal stability of an API can be increased by selecting a coformer with a higher melting point. When working with thermolabile drugs, co-crystals with low melting points can also be useful. The melting point of pharmaceutical co-crystals can be managed by judicious selection of the coformers. Melting point contributes to a major consideration during the formulation of co-crystals. Co-crystals with high melting points are usually needed but they have poor aqueous solubility, whereas low melting point co-crystals have problems with processing, drying and stability, so further study within this area is required [130].
