Applications that are water soluble are absolutely crucial to the pharmaceutical industry. World Pharmaceutical Frontiers speaks to Labaratoria Smeets managing director Dr Jef Verplaetse about the importance of having the right technology in order to deliver drugs more effectively to patients.
Dr Jef Verplaetse: We are a Belgian-based pharmaceutical company that specialises in the manufacturing of pharmaceutical powders and also the packaging of these powders into different types of container, including sachets. The company was founded in 1973 as a family-owned business, and was bought ten years ago by private investors. In 2004, due to strong growth in demand, a new site was added in Antwerp, Belgium. This plant specialises in the mixing of powders and liquids and is equipped with a state-of-the-art analytical laboratory.
Over the last year, we have also just built another new facility, which means we now have three different plants. The new one has been custom-built for one of our customers.
We are using two totally different technologies. One is a hotmelt extrusion and the other is co-crystallisation. We have applied these technologies to active pharmaceutical ingredients (APIs) that could be interesting for veterinary as well as human applications. In veterinary medicine, there is a tendency to use fewer antibiotics and to administer them only at the moment where animals are sick, rather than as a preventative treatment. But if animals are sick they usually stop eating and only drink, which means you can't blend the antibiotic into the animal feed. So you have to administer it through the drinking water.
The problem here is that a lot of products on the market are not water soluble. Most of the newly developed molecules for pharmaceutical applications have problems when it comes to water solubility. If a molecule is not water soluble, it is highly unlikely to be very active and will probably lack bioavailability. It will simply pass through the body and have no effect.
Thankfully, we have a lot of expertise in making products water soluble. We recently developed a technique for converting drugs with poor water solubility (such as class II or class IV of the Biopharmaceutics Classification System) into highly soluble granules, in collaboration with Ghent University. Our technique significantly improves the rate and, to a lesser degree, the extent, of dissolution. This means the API is getting to higher plasma levels, which makes it more effective.
Laboratoria Smeets uses a twin-screw hotmelt granulation technique. What is specific about this technology is that it operates at a low temperature (50°C).
Usually hotmelt technology is associated with relatively high melting temperatures, around 150-200°C. For some APIs, this is acceptable, but for others, it's a problem, because you start to see degradation.
Also, if you melt something at 150-200°C, you get a hard material - like plastic - from your extruder. You then have to grind it in order to make it usable. But we have developed a technology that works at 50°C. So it's a much lower temperature, which most of the APIs can stand. It also means we get a very soft powder directly out of the extruder. From there, we can put it straight into the consumer packaging and it's ready to use - we don't have to treat it with anything afterwards. It's a very simple, straightforward, one-step process.
There a number of particular examples I'd like to share. The first is that we have developed a lot of expertise in the restoration of human intestinal flora in dysbiosis. This situation is present in an estimated 30% of human beings and it leads to conditions such as allergies, irritable bowel syndrome and more. It is a condition of chronic inflammation. We have succeeded in restoring a balanced intestinal flora with a treatment of 90 days, with almost 100% success rate. This offers fantastic opportunities for improving the health of everyone - young and old alike.
We have also developed a product that can effectively restore cartilage. This works in animals such as cats, dogs and horses, but also humans. And a third example is a product we have that can help to restore the biochemical balance of women going through menopause.
The philosophy of our development programme for food supplements is that we recognise that our bodies are able to restore a healthy condition if the circumstances are corrected. This means that we are looking at all the biochemical processes that are involved in certain diseases and trying to compensate for deficits where we find them. We also try to push biochemical processes back into balance by using several innovative ingredients.
There are now new owners of the company, including myself, and, as a company, we are starting to really grow again, which is exciting. Our growth strategy is based entirely upon innovation.
We are fundamentally a manufacturing company, but we are trying to work together with customers and partners who have the capability of marketing the ideas we have. We are helping people to innovate, and sharing our ideas and developments with partners who want to bring these concepts to the market.