The challenge of bolstering the bioavailability of drugs remains a major talking point across the pharmaceutical industry. In response, Merck Millipore continues to provide its toolbox approach to customers’ demands, aimed at enhancing solubility and better controlling release profiles. World Pharmaceutical Frontiers caught up with Steffen Denzinger, head of technical marketing pharma raw materials, to find out more.

What have you identified at Merck Millipore as the key means of improving bioavailability across the pharmaceutical industry?

Steffen Denzinger: There is presently one major challenge for the pharmaceutical industry and, depending on which statistical group you look at, most indicate that 90% of drugs in the clinical pipeline are either BCS class II and IV, meaning they have low solubility and often an even lower permeability. It is also a real challenge for our customers to improve bioavailability by adjusting the formulation.

So, that’s one of the big things at the moment. At Merck Millipore, we feel that it is important to offer a toolbox solution to our customers, working together with them to pick the best-fit solution.

We want to assist our customers by adding more products to our portfolio that are dedicated to enhancing either the solubility of the drugs, targeting or release profiles.

Would you say that there’s a growing sense of awareness among your customers that the bioavailability of active pharmaceutical ingredients is a key to success?

Definitely. As I said, they have this problem in their daily work, and it’s getting more and more difficult to find a solution that is new and really improves the efficiency of disease treatment. For instance, solubility is still a big issue.

So we need more solutions for that, which is what we are hearing from our customers. We have received a lot of positive feedback about our toolbox approach, because a lot of people were coming up to us, usually with a particular problem. And they weren’t looking for a one-size-fits-all solution, but assistance with specific problems.

Could you give some background to Merck Millipore’s new bimodal silica product?

It is a new product, but not novel – which is an important differentiation. In response to the innovative needs of the pharmaceutical industry, we have worked to develop a new silica, which can dramatically help to enhance the solubility of drugs.

We are currently in the pre-launch phase, and have already signed seven contracts with several of our customers, who want us to help them. We have found that there is a wide interest. Obviously, we have other solutions, which are similar, so we are able to benchmark ourselves; we truly have some excellent benchmarking here.

Given the levels of interest already shown in the product, there must be a great sense of optimism for the future?

Sure. But we are not the only ones working in enhanced solubility, which is significant. If you look towards academia, there are about 100 publications published every year on enhancing bioavailability, which highlights the fact that it is a topic that is appreciated and accepted in academia and the scientific community at the moment. That’s the reason we see a high willingness among customers to test this material.

You also have to understand that there is a great deal of technology behind the material, which requires a lot of interaction between us and our customers. We don’t just supply stand-alone products; we help them make the best use of these products.