Press Room

13th Global DDF Summit - Drug Delivery Formulation

Start
Monday, June 27, 2022 - 09:00
End
Wednesday, June 29, 2022 - 17:00
Location: Berlin, Germany
Booth Number: Table 24

On June 27th, don’t miss the Dispersome® session 

Pedro Valente | Hovione

 

Pedro Valente
R&D Director - Oral Drug Product Development, Hovione
speaker - Korbinian Lobmann | Zerion Pharma

 

Korbinian Löbmann
CSO, Zerion Pharma

 

  • Day 1 - June 27th, Small Molecules Stream
  • 12:10 PM - 12:40 PM - Solution Spotlights
  • 'Dispersome® – Novel Bioavailability Enhancement Technology for Poorly Water-Soluble APIs Scalable from Grams to Tons'

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, one obtains a unique amorphous composition of small molecule drugs and proteins.

The technology has been shown to dramatically increase the solubility and bioavailability of poorly soluble drugs, which will be demonstrated by selected case studies in this presentation. These co-amorphous drug-BLG formulations can be manufactured by Spray Drying which is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. A roadmap of the Spray Drying development process will be presented, with all the main steps to bring these new formulations from the laboratory to production scale suitable for Metric Tons.

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

Why you should attend:

  • Learn more about innovation in bioavailability enhancement using BLG
  • Learn how these formulations can be scaled-up to meet commercial supply demand

 

For more information on our session please visit the DDFevent.com

 

 

 

Also in the Press Room

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Continuous Tableting (CT) is defined as continuous manufacturing of oral dose drugs, specifically tablets. As per ICH's Q13 definition1, a continuous manufacturing process in the pharmaceutical industry comprises at least two unit operations integrated from a mechanical and software perspective. There is a wide combination of possible CT process configurations that are dependent on the needs of the intended product formulation and each of the individual unit operations that constitute the process train can be continuous, semi-continuous, or batch processes. The typical manufacturing processes for tablet formulation are direct compression (DC), dry granulation (DG) and wet granulation (WG)2 - details on these manufacturing processes are beyond the scope of this article, so the interested reader is directed to relevant literature. The actual implementation of CT technology in a facility can broadly vary depending on the level of desired integration and automation. Process trains can be designed to be flexible and converted between multiple configurations (e.g. continuous DC, DG and WG), controlled by the end user from one single software and within a single clean room. The other possibility would be for subsections of the CT process to be divided into multiple clean rooms where inprocess materials are transferred between suites via a bin-to-bin approach (e.g. a granulation suite to prepare granules from raw materials followed by continuous DC (CDC) to blend the granules and produce tablets). The level of automation and instrumentation designed into the CT process (typically involving Process Analytical Technologies, PAT) can open the possibility to implement sophisticated control strategies. Key components of a control strategy that need to be considered for CT are material tracking and genealogy, knowledge of the residence time distribution (RTD), and in-process controls (spectroscopic and/or soft sensors based on process parameters). Holistically, these control strategy elements enable the implementation of a material diversion strategy to automatically divert out of specification material from the process. In their most advanced form, control strategies may also enable real time release testing (RTRt) of the final tablet drug product and reduce the off-line analytical burden and the number of operators needed to manage the process.   Read the full article at gmp-journal.com  

Article

Continuous Tableting and the Road to Global Adoption

Mar 04, 2024