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APIs – Continued Growth, Increasing Complexity

Pharmtech 5-2-15I was interviewed back in April for a Pharmaceutical Technology (PharmTech) article about demand drivers for small-molecule APIs. The article by Agnes Shanley – Pharma APIs:  It’s Still a Small World – points out that while biopharma may be hot news-wise, most of the drugs being developed today are still small molecule-based.

While small molecule APIs may not be sexy and are widely ignored by the media in favor of the most recent gazillion dollar reverse merger M&A deal, there’s plenty happening in the industry – and much of it is driven by complex chemistry developments.

In the article, I discussed Neuland’s more recent foray into deuterium chemistry.  Still a relatively young field, most products are currently still in pre-formulation. Nonetheless, the use of deuterated compounds might potentially increase the bioavailability of active drug compounds and result in improved safety profiles.

Quality by Design

Regulatory changes have also had an impact on the production of pharmaceutical actives. Quality by Design (QbD) is an example of an emerging trend in pharma development. At Neuland, we’ve started utilizing a multidimensional approach to our projects, using Design of Experiments (DOE) and Design Space concepts from the earliest phases. By acquiring a better understanding of the process as early as possible during the development phase, we can potentially improve the efficiency of scale-up and minimize out-of-spec (OOS) issues.

Delivery Developments

Other developments are occurring in the field of delivery, with the search for alternatives to the ‘little white pill’ (still the mainstay of small molecule pharma). Much is occurring in the fields of injectables, inhalables and topical administrative routes, leading to more complex development work. In the article I referenced anti-asthmatics, in which very precise control over particle size distribution is needed.

For us, small molecule APIs have been our bread and butter for over 30 years.
And while they may not make it consistently above the fold of the New York Times, neither does rubber.
But it’s difficult to drive without tires.
And it’s difficult to take a prescription drug without small molecule APIs.

Read the full article at PharmTech.


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