The success of several drugs in amorphous systems in the commercial market confirm that amorphous drug delivery system is one the efficient ways of enhancing solubility and optimizing bioavailability of poorly soluble drugs. Spray drying and hot melt extrusion are the two technologies most widely used for the preparation of amorphous solid dispersion. In addition, co-amorphous systems are also emerging as an attractive formulation strategy for poorly water-soluble drugs. However, its use in drug development is somehow limited due to a lack of understanding of mechanisms governing drug amorphization, stabilization and absorption in vivo.
In this webinar, a renowned expert will provide an overview of co-amorphous research and its recent findings. In particular, the impact of low molecular weight excipient on developability, stability and solubility will be discussed. A Catalent expert will then discuss the amorphous dispersion formulation via spray drying and hot melt extrusion while covering topics such as determining if an API is suitable for amorphous solid dispersions formulation, leveraging the physical and chemical characteristics of an API to design amorphous solid dispersions, understanding the critical criteria for candidate selection, and assessing the appropriate technology to use for a specific API.
Date: Thursday, May 6, 2021
Time: 11 a.m. CET
Venue: Online
AGENDA
Co-Amorphous Drug Systems with Additional Polymer/Excipient, Mechanism of Stabilization, Impact on in vitro Performance
- The use of low molecular weight excipients to stabilize the amorphous form of drugs, focusing on the three critical quality attributes “co-formability”, “physical stability” and “dissolution/solubility”
- The impact of addition of excipients, including polymers, to co-amorphous systems
- Short gap-analysis in co-amorphous research
Prof. Dr. Dr. h.c. Thomas Rades
Research Chair in Pharmaceutical Design and Drug Delivery
University of Copenhagen
Amorphous Dispersions in Oral Small Molecule Formulation Development
- Spray drying process overview, solvent and polymer screening and identifying lead dispersions
- Hot melt extrusion process overview, polymer selection and drug load optimization
- Hot melt extrusion vs. spray drying and path to finished dosage form
Dr. Matt Ling
Director of Scientific Services, Oral & Specialty Delivery
Catalent
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