Finding Optimal Form

by: Catalent
There are many hurdles in drug development, but your chances of success increase significantly if you pay more attention to API optimization from the outset.

The high costs of bringing a new drug to market are notorious and often dominate discussions about the challenges facing today’s drug developers. With so much attention focusing on financial aspects, it can be easy to overlook more practical development steps. In fact, formulators face many of the key problems at the very early stages of R&D: how do you optimize the molecule’s stability? How do you enhance bioavailability? And how do you select the optimal delivery method? Addressing these issues early – and comprehensively – can lead to less problems down the line, and helps to avoid overly long development times and the associated costs. Long development times, and the selection of the right formulation and delivery platform, have been cited as the top challenges (in addition to cost) for formulators and R&D managers (1).
At the early stage of development, a common  problem  with the molecule is lack of bioavailability. “70 percent or more of new chemical entities (NCEs) face bioavailability challenges, which often expand beyond solubility and permeability,” explains Julien Meissonnier, Vice President of Science & Technology at Catalent “We are also seeing an increasing number of NCEs that, when developed, are not appropriate for their chosen delivery system. Sometimes these compounds eventually reach the market in a sub-optimal form, but they do not realize their true potential, nor meet the expectations and needs of patients. The right delivery technology can make a huge difference.”
The early development stage is actually a golden opportunity to make the most critical decisions. During this period, formulators build a huge body of knowledge about the molecule, such as an understanding of its stability, affinities, and particle and bulk attributes, which can be used to dictate and optimize the molecule’s future development, final dosage form and manufacturing process. Although there is awareness in the industry that optimization and the use of quality-by-design principles at the early stages of development are directly linked to a product’s future success, the big question for many is, how exactly is this achieved – especially when being asked to make formulation decisions quickly…..
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Source: The Medicine Maker