Area of presentation: Excipients - HPMC Capsules in prescriptions pharmaceuticals: Emerging trends
Speaker Name: Laurent Bouché - Pharmaceutical Project Manager, Capsugel Ploërmel France
- What are the current global trends driving the pharmaceutical sector you are working in? How does your company respond to those trends?
The pharmaceutical industry is being reshaped with the demand for more specialized medicines and treatments. More highly potent compounds are in the development pipeline. Virtual, small and specialty companies are driving early stage pipelines, and rapid screening of API candidates is more critical than ever. Capsugel is assisting our customers with specialized API feasibility assessment tools such as Xcelodose Precision Powder Micro-Dosing Systems and services that can be utilized for rapid and effective POC through phase II studies.
2. What are the top challenges faced by the pharmaceutical sector you represent at this moment? How does your company deal with these challenges?
Due to the high cost of the development of new chemical entities and the current low overall productivity of obtaining successful candidates, the pharmaceutical industry is being required to develop accelerated POC strategies. This start with the formulation design for the early clinical programs. At Capsugel, Micro-dosing for PIC evaluations is a key component of our early stage product development offering aimed at accelerated feasibility studies and first-in-human (FIH). By combining market-leading experience in micro-dosing and Capsugel’s Xcelodose® Precision Powder Micro-Dosing Systems, we provide premier PIC evaluations and services for preclinical studies in support of client projects. PIC programs are generally completed 45% faster than traditional formulation development approaches using excipients, resulting in time savings of 13-17 weeks
3. What topic are you presenting at the Pharma Insight Briefings and why is this subject so important to the market at this time?
The presentation will look at rapid advancement tools and approaches that allow to accelerate first in human studies while sparing API consumption essentially through the microdosing approach combined with functional capsules and encapsulation technologies for immediate or modified release.
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?
Attendees will be able to hear how microdosing approach combined with use of functional capsules can dramatically accelerate feasibility and FIH studies while sparing API consumption. I will be sharing some of Capsugel developed best practises around API in capsule dosing utilizing the Xcelodose equipment.
5. How do you see your sector of the market evolving in the next 5 years?
I believe Pharmaceutical companies, whether large, medium and small increasingly relying on CDMO partners especially for specialized enabling formulation technologies that require specialized expertise and manufacturing capabilities but also to support them in meeting their timeline targets when it comes to supplying FIH clinical batches. Moving forward, in an environment where development budgets are tight and where there is pressure to minimize development spend before proof of concept, the direct and indirect cost savings associated with adopting an API-in-capsule approach continue growing as an attractive screening and development approach.