Area of presentation: ICSE General Contract Services - QbD applied to lipid-based pharmaceutical products
1) Alyn McNaughton - Speaker Job Title: Technical Director
- What are the current global trends driving the pharmaceutical sector you are working in? How does your company respond to those trends?
In spite of considerable efforts to reduce physicochemical liabilities, and to design in reasonable ‘developability’ characteristics in prospective drug candidates, pharmaceutical discovery programmes continue to identify drugs with low water solubility, limited cellular permeability and high metabolic clearance—properties that are expected to reduce oral bioavailability. Of the limiting factors to oral drug delivery, low water solubility is perhaps the most amenable to resolution based on the use of enabling formulation approaches. Capsugel is a leader in drug solubility and enhancement of solubility or dissolution rate. Our depth of bioavailability enhancement technologies and their application enables us to work collaboratively with our customers to advance compounds with a range of properties and delivery challenges.
2. What are the top challenges faced by the pharmaceutical sector you represent at this moment? How does your company deal with these challenges?
Industry estimates indicate that between 60-90% of new chemical entities exhibit poor solubility or dissolution rate. Effectively addressing these issues is essential for the development of drugs with adequate bioavailability, which is crucial if a drug is to provide the desired therapeutic benefit to patients. At Capsugel, rather than relying on trial and error, we use a fundamental, model-based approach to select the best technology for each of our customers’ compounds based on key API parameters and in-vitro testing methods. We further build on that approach with formulation optimization and, process development, we are applying quality by design principles to ensure final product performance and robustness during scale-up phases to advance medicines first to the clinic and then to commercialization.
3. What topic are you presenting at the Pharma Insight Briefings and why is this subject so important to the market at this time?
Lipid-based formulation (LBF) approaches — encompassing the use of lipid excipients, solvents, co-solvents in liquid, semi-solid or solid formats — are a key tool for improving solubility. LBF is primarily used for bioavailability enhancement, along with addressing food effects and associated variability. Additionally, liquid or semi-solid LBF approaches are routinely utilized for low dose/highly potent applications, due to the ability to achieve uniform API distribution at low dosing, and to minimize exposure hazard. The presentation more specifically will look at applying the Quality by Design principles to LBF dosage forms
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?
QbD applied through scientific approaches to the development and validation of Lipid based formulations and commercial processes can shorten project timelines while reducing risks and gaining valuable product knowledge. I will review case studies during the presentation looking at both soft gelatin capsule and liquid filled hard capsule products.
5. How do you see your sector of the market evolving in the next 5 years?
The continued growth in specialized and complex medicines are expected to continue driving LBF applications and liquid and semi-solid filled dosage forms. Expertise in QbD and efficient scale-up from concept to clinic and commercial scale is critical in bringing these dosage forms to market. QbD is a proven cost and time efficient approach in design and manufacturing across all dosage formats. Design of Experiment (DoE), risk assessment, and Process Analytical Tools (PAT) are utilized to achieve a better understanding on the materials and processes, and enable QbD applications to be readily applicable to liquid filled hard capsule and soft gel formulations.