How has Dow’s presence evolved in the life sciences space, and how has the DuPont merger impacted the company’s strategy?

Dow has had a strong presence in the pharmaceutical industry through its excipients offering for a long time. Some of the more prominent changes include the acquisition of the other half of Dow Corning, which brought a range of silicon-based products into our portfolio, introducing new applications such as topical development and transdermal films – areas in which Dow has traditionally not had a strong presence. Historically, our main competence has been oral solid dose, an area in which we continue to be very strong.

The merger with DuPont plus DuPont’s acquisition of FMC has added another set of excipients to our portfolio, primarily focused on oral solid doses but very complementary to Dow’s existing portfolio. We now have a product portfolio that touches almost every aspect of oral solid dose, from tablet binders for compression and granulation binders to tablet coating systems and modified release matrices.

Bioavailability and solubility enhancement are primary considerations for any drug development company. In what ways can Dow support the efforts of these companies?

We have been heavily researching the area of solubility enhancement for some time. Many new APIs coming out of development need significant solubility enhancement to boost their effectiveness. A couple of our polymer products are already in the market as lead candidates. One of these is hydroxypropyl methylcellulose acetate succinate (HPMC-AS), a soluble polymer with PH-dependent solubility, which can be used to get a drug past the stomach and into the intestine, for example, before the coating dissolves and releases the drug. This works particularly well in spray-dry dispersions, a technology by which a poorly-soluble drug can be dissolved in a non-aqueous solution and spray dried – the polymer helps to lock in the active ingredient in a higher-energy but more soluble form.

What we really bring to the table is the ability to modify the polymer within monograph ranges, so it is appropriate for drug solubilization. Not many companies have the scale or scientific expertise for this. We have put together a Formulation-By-Design kit, which enables customers to test different ranges and find the polymer that works best for solubility enhancement.

Whilst oral solid dose remains the leading dose form, are there any trends towards other dose forms?

Oral solid dose remains the largest market and most preferred way to administer medication. Topical administration is becoming more popular, as well as transdermal. These are interesting because they include technologies with favorable applications in pediatric and geriatric care, with drivers from both a regulatory perspective and population demographic perspective. Being able to administer medication to geriatric patients in a way that does not require the patient to remember to take a pill in favor of a long-acting patch, for example, is a huge advantage.

Companies are pursuing more challenging therapeutic areas and approaches, which is driving a lot of earlier-stage interest in parenteral-type applications. However, these trends are not yet seen in the mass market. Even in these instances, there is still a preference to move away from injectable formulations to an oral formulation where possible.

What are the advantages of Dow’s global presence, and are there any areas of strategic focus within the United States?

The pharmaceutical market is very much global and ebbs and flows – a formulation developed in one region may end up being manufactured in another region. It is critical to have a global perspective and reach. We have a number of production facilities in the United States in various locations, plus manufacturing sites in Europe. Our supply chain is very extensive and robust. We see a great deal of activity in Boston/Cambridge and the Bay Area for emerging technologies – there are a lot of smaller independent companies that are eager to pursue next generation solutions. We try to connect with as many of these teams as possible to show them what we can offer from a polymer science perspective and get feedback on their performance needs and requirements.

What are the next areas of focus in terms of R&D and new additions to the portfolio?

We remain primarily focused on excipients and we are not developing new dosage form technology ourselves. However, we are participating in the development of many of these new doses – we are interested in working with companies in 3D printing, for example, to work out the excipient needs. There is also currently a great deal of research around continuous manufacturing and better flow performance – we want to be part of these conversations from an excipients perspective. For example, Dow’s METHOCEL^TM DC2 polymers have better flow performance to enable direct compression and skip granulation steps, which is more amenable to a continuous manufacturing process. We are constantly in a feedback loop with the industry to understand its excipient needs.