Dispersome® – Understanding formulation principles and manufacturing behind this new Bioavailability Enhancing Technology

Register Free: https://www.pharmtech.com/pt_w/Dispersome

Event Overview:
Poor drug solubility is one of the most challenging issues in drug development. Up to 90 % of all newly discovered drugs show insufficient aqueous solubility in their crystalline form, resulting in too low bioavailability, because the drug must dissolve in order to be absorbed and reach its pharmacological target. Many promising drug candidates are thus discontinued during early-stage development due to poor bioavailability resulting from low solubility.

The Dispersome® technology is a novel solubility enhancing approach that is based on using the protein beta-lactoglobulin (BLG) as novel pharmaceutical excipient. By mixing a drug compound with this by-product from cheese production, a unique amorphous composition of small molecule drugs and proteins is obtained.

The technology has been shown to dramatically increase the solubility and bioavailability of poorly-soluble drugs, which is demonstrated by case studies. These co-amorphous drug-BLG formulations can be manufactured by spray drying. In this presentation, a roadmap of the spray-drying development process, including solution preparation, spray drying and secondary drying, will be covered. Considerations are made on both, formulation and manufacturing processes, all of which are important to bring these new formulations from the laboratory to production scale.

A focus will be given to the importance of lab-scale familiarization and supporting studies throughout the development process as well as how computational, statistical tools combined with prior knowledge can be capitalized to reduce risk while maximizing time and resources.

Key Learning Objectives:

• Innovation in bioavailability enhancement using BLG
• Amorphous stabilization using proteins as excipients
• How formulations can be scaled up to meet commercial supply demand
  

Who Should Attend:
This webinar is targeted at scientists and managers working in the field of pre-formulation, formulation, and CMC. The webinar has a focus on solid oral dosage form development for poorly-soluble drugs.

Speakers

Pedro Valente
Oral Drug Product Development
Hovione

Dr. Pedro Valente is the director of oral drug product development at Hovione R&D, specializing in formulation, particle engineering, and process development of pharmaceutical drug products for oral delivery. Prior to joining Hovione as an R&D scientist in 2015, Pedro worked as aerothermodynamics engineer at Volvo Aero Corp. in Sweden (now GKN aerospace) and later on was an invited lecturer and researcher at the University of Lisbon, covering the areas of fluid mechanics and turbulence. Valente holds a PhD from Imperial College London (UK) in aeronautics and MScs from the U. Lisbon, Portugal (Mech. Eng.), and from Chalmers Technical University, Sweden (fluid dynamics and turbulence).

Email: pvalente@hovione.com

Korbinian Löbmann
CSO
Zerion Pharma

Dr. Korbinian Löbmann is the CSO at Zerion Pharma, a university spin-out that he co-founded in 2019. He has more than 10 years of experience in solid formulation and dosage form development, including preformulation, formulation, processing, and manufacturing together with the relevant solid-state characterization and quality control. This includes the development of new enabling formulation strategies for poorly soluble drugs using amorphous drug delivery systems. Löbmann received his PhD in pharmaceutical sciences in 2013 from the University of Otago, New Zealand and then joined the University of Copenhagen, where he was appointed assoc. prof. in 2017. He has authored more than 100 peer-reviewed papers and patents.

Email: kl@zerion.eu

Register Free: https://www.pharmtech.com/pt_w/Dispersome