Press Room

14th Global DDF Summit - Drug Delivery & Formulation Summit

Start
Wednesday, May 31, 2023 - 00:00
End
Friday, June 02, 2023 - 00:00
Location: Berlin, Germany
Booth Number: Table #25

Hovione will be exhibiting at the Global DDF Summit, the premier drug delivery, formulation and device development event from 31 May – 2 June in Berlin. 

Don’t miss the chance to speak with our experts – Table #25 – and learn how our extensive knowledge and experience can support you from the early stages of development for low solubility APIs, increasing drug product performance to commercialization.

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Get to know more about ASD-HIPROS, the most advanced and accurate screening platform able to identify the most efficient and stable Amorphous Solid Dispersion formulations by Spray Drying. Requiring as little as 5g of API, ASD-HIPROS rapidly screens for the best combination of drug loads, excipients – including Dispersome® BLG novel protein-based excipient – and surfactants with an advanced computational tool followed by Spray Drying of up to 24 of the most promising formulations.  

 

 

On May 31st at 2:40 PM (local time), don’t miss our Technology & Innovation session with Mafalda Paiva, Senior Manager, R&D Analytical Development at Hovione

 

"ASD-based oral drug product development: the role of biopredictive tools"

Abstract:
A faster and reliable early development phase is what the industry seeks, the patient expects, and the scientific community contributes to. At Hovione, we’re working to second this with high-throughput approaches for amorphous solid dispersions (ASD)-based oral drug product development with the most adequate functional excipients. This is supported by the understanding of the mechanisms that underly enhanced performance. Dissolution and permeation mechanisms of ASDs are complex and have increasingly been studied over the last years. This knowledge and the link between enhanced drug exposure and process parameters are key when formulating BCS II and IV poorly soluble compounds. One of the mechanisms identified relates to the ability of some ASDs to form drug rich colloids. These structures can, and often do, behave as a drug reservoir acting as a continuous supply of drug as it permeates. Along with the increasing demand for complex formulations comes the need for appropriate in vitro methodologies capable of predicting their corresponding in vivo performance and the mechanisms controlling the drug release which can impact on in vivo drug absorption. In this presentation we'll review formulation strategies to enhance drug exposure and the in vitro methodologies that can support effective in vitro formulation screening. Also, the data presented can shed light on the important dissolution and permeation mechanisms that govern increased drug product performance and how this knowledge - currently part of Hovione portfolio - can be a reliable partner at the early stages of development for low solubility APIs. 

 

Schedule a meeting with our experts and learn how we can increase your drug solubility with clear benefits for patients.

 

 

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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  

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Continuous Tableting and the Road to Global Adoption

Mar 04, 2024