Development of new active pharmaceutical ingredients (APIs) lengthy poor drug solubility is one of the most inhibiting factors in drug product development. The Developability Classification System (DCS) was developed to assist formulation scientists and provide guidance on the various formulation strategies to overcome solubility issues by physical modifications, using solubilization promoters and solid dispersion technology.
In this context, hot-melt extrusion is one of the key technologies to address poor drug solubility. This webinar will provide you with an overview of the DCS and different formulation strategies as well as give you a deep-dive into hot-melt extrusion technology and which excipients are suitable for this process.
Speakers
Markus Lubda, Ph.D.
Merck
Strategic Business Manager
Markus is a biomolecular engineer. He is responsible for the strategic development and positioning of an excipient portfolio for oral solid dosage form applications. Thereby, the focus is to enhance solubility and bioavailability of the most challenging APIs with specifically engineered excipients for oral solid application. He holds a Ph.D. in biology/chemistry from the Technical University of Darmstadt and is a biomolecular engineer.
Nadine Gottschalk
Merck
Principal Scientist
Nadine is a principal scientist within our process and formulation materials area. She is a pharmacist by training and has a strong background in solid dispersion technology and additive manufacturing. As part of the solid formulation R&D team, she is a technical project lead for excipient development. Her focus areas are solubility enhancement and advanced manufacturing technologies.
Pharma and biopharma manufacturing
- Liquid Formulation Strategies
Durée:1h
Langue:English
Session 1:présenté(e) May 23, 2023
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