Oral solid dosage forms, including tablets and capsules, continue to be the dominant mode of delivery in the pharmaceutical market. They are the preferred option for many drug products because they continue to offer the most cost-effective and patient compliant solutions to drug delivery. In fact, in 2015, out of 45 new molecular entities (NMEs) approved by the FDA, more than 50% were solid dose products—15 tablets, 8 capsules.

As the growing market for large molecule drugs continues to pick up pace, the future of oral solids will likely rely heavily on not just generics, but also niche drugs and especially high-potency compounds. Markets for oncology and central nervous system (CNS) disorder drug products, for example, are growing somewhere in the mid-teens in terms of units over the next 5-plus years.

Perhaps partly in response to these types of trends, former U.S. President Barack Obama in his January 2015 State of the Union address launched the National Precision Medicine Initiative, created “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized treatments.”

With regards to the outsourcing of oral solid dose manufacturing, it is likely that innovation will come in the areas of improved drug delivery and enhanced efficacy. In, “Oral Solid Dosage Outsourcing: Trends & Challenges,” we talked to several contract service providers about the dynamics of today’s oral solids market.

One thing for certain is that pharma sponsors today are increasingly demanding of their contract service partners to provide expertise and sophisticated solutions. Gone are the days when all a sponsor wanted was a straightforward manufacturer of tablets.

They expect close relationships on quality, scientific collaboration and supply chain integration. Sponsors are also looking for partners who have the technical expertise to maximize a product’s value and provide complete lifecycle management of products.

True innovation also requires a deep understanding of patient needs and wants, according to Emilie Branch from That’s Nice. She offers a look into the psychological associations related to a drug’s physical appearance and says  there is not a one size, shape or color fits all solution and these efforts will require a deeper understand of patient psychology.

From a more technical perspective, experts from Patheon look at how to narrow down the many available approaches to solubility enhancement and formulation development to ensure product success, while in, “Know Your Drug: A Solution to Dissolution,” a team of Hovione experts examine key strategies for solubility and dissolution assessment of new drug products, drug product intermediates and APIs.


Tim Wright, Editor
twright@rodmanmedia.com