Area of presentation: ICSE General Contract Services - Spray Drying for Inhaled Dosage Forms
Speaker Name: Dr David Lyon - Technical Director
1. What are the current global trends driving the pharmaceutical sector you are working in? How does your company respond to those trends?
The personalized medicines era is shifting the focus of pharmaceutical development and manufacturing activities within small molecules and inclusive of biologic drug products. Though local treatments utilizing pulmonary delivery remain dominant, e.g. COPD, asthma, there is increasing exploration of the use of the lung for more systemic treatments, e.g. pain management. There is growing utilization of complex macromolecule delivery to the lung, e.g. vaccines, however, these applications are not as straightforward as their small-molecule counterparts. Most biologic products are still delivered via parenteral administration but interest is huge for alternative routes including oral administration as well as pulmonary or nasal delivery. We, at Capsugel, have developed the expertise and capabilities to help the pharmaceutical industry respond to these growing needs.
2. What are the top challenges faced by the pharmaceutical sector you represent at this moment? How does your company deal with these challenges?
As mentioned before, there is growing interest in delivering biotherapeutics to the lung such as vaccines that might promote enhanced antigen response in the area where the virus first enters the body. But, often these molecules are challenging to deliver utilizing the most established delivery options because they are not compatible with reducing sugars and are sensitive to attrition milling. There is also increased interest in delivering antibiotics to the lung to aid patients with compromised lung function (typically CF patients) that tend to have increased risk of lung infection due to poor escalatory clearance. These therapies require the delivery of large doses, often much higher than 5mg of active per respiratory event, which is very limited with lactose blend DPI or pMDI technologies. Thus, an enabling technology platform such as spray drying for effective particle engineering and precluding the need for carrier-based delivery systems is required to tackle such issues.
3. What topic are you presenting at the Pharma Insight Briefings and why is this subject so important to the market at this time?
New concepts and actives – both small and large molecules - being utilized in inhaled therapeutics increasingly require innovative approaches and technologies. Therapeutic approaches and devices are becoming much more tailored to specific patient populations. Many of these actives require formulation and delivery beyond the performance range of more precedented technologies such as DPI based on conventional lactose blended formulations. The presentation will look at spray drying as a powerful enabling technology platform that avoids carrier-based systems, achieves superior particle size control, and brings more flexible in terms of formulation options for enhanced inhalation therapeutics.
4. What can attendees to your session expect to gain and which challenges does this content address? Why should they include your presentation in their agenda?
During the session, we will look at how particle engineering via spray drying can enable inhalable formulation development of a wide range of APs including large biological molecules. Process and formulation attributes will be discussed as well as approaches that can further streamlined timelines and costs. Supportive data will be shared that demonstrates effective drug concept development based on spray dry processing and encapsulation.
5. How do you see your sector of the market evolving in the next 5 years?
We see Pharmaceutical companies, large, medium and small increasingly relying on CDMO partners especially for specialized enabling formulation technologies that require specialized expertise and manufacturing capabilities. But finding the right partner is not only about technology, I think what matters is to always keep in mind that there is a patient at the end and also to understand all the regulatory implications of the technology choice.