Knowledge Center
Webinar - ¶Ù¾±²õ±è±ð°ù²õ´Ç³¾±ð® – Understanding formulation principles and manufacturing behind this new Bioavailability Enhancing Technology
Recording available soon
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Speaker |
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| Pedro Valente, PhDÌýÌý–ÌýDirector of oral drug product development at ËÄÉ«AV R&D |
| Korbinian Löbmann, PhDÌý–ÌýCSO at Zerion Pharma |
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Key Learning Objectives:
- Innovation in bioavailability enhancement using BLG
- Amorphous stabilization using proteins as excipients
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 ¶Ù¾±²õ±è±ð°ù²õ´Ç³¾±ð® 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.
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Recording available soon
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