Hard Capsules: Facts and evidence throughout a new product development
Pharmaceutical companies and contract manufacturers oftentimes select the final oral dosage form according to the manufacturing equipment and qualified personnel within the production sites, especially those with a history of positive performance, in an attempt to mitigate possible risk. However, from the financial perspective, it is important to take into account not only the production speed and yield of existing certified installed machines during commercial production, but also other variables that influence the entire process of arriving at the final drug product.
When considering hard capsules as an alternative to the more common tablet, this includes aspects such as the benefit of using fewer excipients, faster R&D timelines, and the fewer number of manufacturing steps in several types of developments, with subsequent less analytical and validation effort, as well as less maintenance and cleaning cost. Especially attracting interest in hard capsules is the fact that capital investment is reduced to a significant degree, due to the simplicity of the manufacturing process for filling hard capsules.
In this webinar, some key considerations of hard capsule R&D activities will be described in comparison to tablets, as well as core differences in the manufacturing and validation processes. Results from survey studies will be shown regarding patient perception and preferences, in order to round out the most important characteristics of delivering a solid oral dosage form.
Attend this webinar presented by Qualicaps® and the University of Heidelberg for a better understanding of the relevant aspects when undertaking a new drug development cost/benefit analysis, as well as the versatility and positive appreciation of the capsule solid oral dosage form.
Presented by
Susana Ecenarro Probst,
Qualicaps®, Director of Scientific Business Development
Susana Ecenarro is the Scientific Business Development Director of Qualicaps Europe. She holds a MBA and a bachelor degree in Pharmacy. Prior to Qualicaps she worked for the german pharma company Schering AG for 18 years in different quality positions and covering several functions as analytical development, process validations, technology transfers, operation excellence projects, etc., followed by 5 years of experience leading an analytical R&D unit of a Bayer Healthcare facility.
Her main work mission in Qualicaps is to support R&D centers within the Pharmaceutical industry in new drug developments by providing the scientific and technical expertise they might need, as well as promoting collaborations with European universities or third parties focusing on the application of state of the art capsule technologies.
Gabriele Reich, PhD,
Academic Director / Research Group Leader
Gabriele Reich is academic director and research group leader at the University of Heidelberg, Institute of Pharmacy and Molecular Biotechnology (IPMB), Dept. of Pharmaceutical Technology and Biopharmaceutics.
She holds a PhD in Pharmaceutical Technology and has more than 20 year experience in scientific research, academic teaching and international industrial consulting with a proven record of accomplishments in diverse areas of pharmaceutical technology, analytics, biopharmaceutics and polymer chemistry.
Her research activities are focused on solid oral dosage forms with special emphasis on QbD approaches and PAT solutions. Current projects of her research group comprise the development and characterization of innovative hard and soft capsule products as well as polymer-based drug delivery systems with tailored release characteristics.
She is a member of AAPS and the APV focus group ‘solid oral dosage forms` and has been responsible for the organization of numerous international pharmaceutical conferences, seminars and workshops.