MEGGLE Excipients

Constanze Mueller

This article is based on an interview with Constanze Mueller, Business Development Inhalation, MEGGLE Excipients.

Engaging with Potential Clients or Partners to Understand Their Specific Needs and Tailor High-Quality Solutions for Inhalation Therapies

At MEGGLE Excipients, we attach great importance to providing our customers with close and intensive support. Therefore, the first step in understanding our customers’ needs is direct contact and conversation with them. Our sales partners, area managers and our R&D team are closely engaged. It is particularly important to emphasise that all our sales managers have a profound knowledge of application technology and are experts in excipients. On the R&D side, we support application studies that help our customers to develop or improve their products faster. For this purpose, we have application laboratories worldwide.

Additionally, our highly experienced product development team might help tailor customised solutions. To stay tuned on the latest developments, my colleagues and I are present at any bigger conference in the inhalation field. We observe that for more tricky inhalation developments, there is an increasing need for consulting. That's why my position is dedicated to bridging the market intelligence. Customer needs into our R&D team and taking care of global customer needs for our inhalation grades (InhaLac^®) together with my local colleagues. The right choice and support with relevant data gives our customers a decisive advantage in the development of new products. 

Experiences from Successful Inhalation Product Development Projects You’ve Managed

We naturally serve a large number of customers worldwide in various markets, from originators to generics manufacturers. It is very important to us to maintain confidentiality, so I do not want to go into individual projects at this point. IP, authorship and confidentiality are of the utmost importance. However, I am happy to talk about an ongoing project in our application and innovation campus. We are currently testing how we can best mimic Spiriva's PSD with our products. I find it interesting that although Spiriva's patent has already expired in 2017, there are still very few generics on the international market. We have investigated to what extent the originator PSD can be mirrored with our grades. It turned out that although we already have a very large portfolio, there is a gap between INH 140 and INH 150. 

We have therefore developed our latest product, INH 145. It is a milled product that has the same excellent characteristics as our other products but closes this PSD gap between INH 140 and INH 145. This enables our customers to be more flexible and to realise any kind of DPI formulation.

"Innovative excipients are, of course, relevant and have their place, but I still think it's wonderful when a very well-known excipient that is proven to be safe and stable can be used in innovative solutions."

Risk-Related Challenges in the Development or Distribution of Inhalation Products

In terms of risk-related challenges, I would like to take this opportunity to briefly address the issue of nitrosamines. As we all know, back in 2018, N-nitrosodimethylamine (NDMA) was found in valsartan formulations. Since then, there have been more and more discoveries of other nitrosamines, and therefore, the authorities have requested that a risk assessment be carried out and appropriate steps be introduced. Nitrosamines can be formed by amines and nitrosating agents. The primary nitrosating agent, which can occur in extremely small quantities in lactose, is nitrite. This is, of course, why we carried out our risk evaluation. I would like to point out that lactose, unlike other excipients such as MCC, contains very small amounts of nitrite. Our lactose is typically below 0.1 ppm. Since, as mentioned, the values for other excipients are significantly higher, other excipient manufacturers are also focusing more on this topic and even using it for marketing purposes. MEGGLE lactose stands for outstanding quality and purity. We support our customers in dealing with the topic in an objective and target-oriented manner. As a consequence, we have prepared training documents for this purpose. Finally, I would like to mention that critical concentrations of nitroamines in DPI formulations are not a problem due to the low dosage. Still, of course, we provide regulatory assistance and documentation.

Exciting Emerging Technologies or Innovations in Inhalation Therapy Solutions

I find the current developments in the field of RNA therapeutics very promising and exciting. The potential field of application includes many indication areas. I am pleased that lactose seems to be very well-suited here. Innovative excipients are, of course, relevant and have their place, but I still think it's wonderful when a very well-known excipient that is proven to be safe and stable can be used in innovative solutions.