What common API problems continue to plague pharmaceutical manufacturers?
The solubility and, hence, bioavailability of APIs — particularly new APIs — is an increasing industry problem for many reasons
- High-throughput screening is resulting in more complex API structures with an increase in BCS Class II (low solubility and
high permeability) and Class IV (low solubility and low permeability).
- A large number of recent drug candidates or new APIs are in Class II.
- About 40% of the APIs currently on the market show poor solubility and 90% of the APIs in development are poorly soluble!
Numerous APIs do not even enter development due to extremely low solubility in water.
In many cases, the formulation has to bring a high dosage of the drug to increase its bioavailability, which can lead to unreliable
efficacy, an increase in costs and stability problems.
For many years, the industry has conducted research and development into new excipients in order to help overcome the above
issues. Today, a wide range of solubilisers and solvents are available. One technology that has gained significant interest
is hot melt extrusion (HME). Although this technique has been used in the plastics and food industries for decades, it is
relatively new in the pharmaceutical industry and only a few drug products are currently available on the market. The technology
shows numerous benefits over traditional/classical methods including shorter processing times because of continuous downstream
processes, environmental advantages due to elimination of solvents, and increased efficiency in drug delivery.
Looking ahead five years for now, how do you see the market for APIs evolving?
The market for APIs continues to grow above the overall pharma market because of the trend towards generics in both the established
and emerging markets. For pharma companies, we will see ongoing consolidation and a stronger focus on the emerging markets,
which are experiencing high-growth rates because of their increased expenditure on healthcare.
Suppliers and pharma companies will have to address the specific needs of the consumers in this regions with specially tailored
products and new solutions that serve these markets in a cost-competitive way. To meet this challenges, it can be beneficial
for companies to partner with global suppliers that help them to both reduce costs and cope with the unique challenges posed
by emerging markets, such as local regulatory requirements and the fluctuations that are often seen in demand. Indeed, because
of the rising complexity of business in the pharma landscape, selecting the right API supplier is becoming ever-more important.