Developing high-quality oral formulations specifically for children is increasingly important. For age-appropriate medicines, different physiological needs must be considered. In addition, there are high demands on patient compliance: palatability has to be addressed during the development process and optimized child-friendly dosage forms are required. To support the well being of little patients, the careful selection of excipients plays an important role.
In the webinar, you will gain insights in new requirements for the testing of high-risk components on the impurities diethylene glycol and ethylene glycol. In addition, case studies for child-friendly dosage forms will be presented.
In this webinar, you will learn:
- About the latest regulatory trends and requirements in the EU and in the USA for pediatric formulations, particularly with regards to critical impurities like ethylene glycol and diethylene glycol
- About important aspects for the selection of suitable excipients for oral formulations
- How to develop child-friendly orodispersible mini-tablets and films for enhanced patient adherence
Speakers
Almut von der Brelie
MilliporeSigma
Senior Strategic Product Manager, Excipients Solid Application
As a food chemist by training, Almut von der Brelie has more than 17 years of experience in the global B2B marketing for functional cosmetic, food and pharmaceutical ingredients in highly regulated markets. In her current position as a strategic product manager, she is driving product innovations for solid dosage forms with a focus on the design of tablet film coatings and taste optimization.
Markus Greulich, Ph.D.
MilliporeSigma
Strategic Marketing Manager, Excipients Liquid Application
At MilliporeSigma, Markus is responsible for a broad portfolio of pharmaceutical excipients with a focus on regulatory topics. Prior to coming to MilliporeSigma, he worked in product development at RP Scherer/Catalent Pharma Solutions where he was responsible for formulation development and project management. Markus holds a Ph.D. in Pharmaceutical Sciences from the University of Heidelberg, Germany.
Lars Albermann, Ph.D.
MilliporeSigma
Head of Pharma Registration and Regulatory Projects
A molecular biologist by training, Lars has been working in several regulatory positions in pharmaceutical industry (for both drug products and pharmaceutical raw materials) as well as contributing to a number of industry associations, joining MilliporeSigma in 2012.
Currently, he is responsible for a team of regulatory experts in life science regulatory management. The team is working on regulatory topics mainly related to APIs and excipients, supporting a number of manufacturing sites as well as global activities.
Pharma and biopharma manufacturing
- Liquid Formulation Strategies
Duration:1h 5min
Language:English
Session 1:presented June 13, 2024
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