Press Room

RDD Europe 2019

Start
Tuesday, May 07, 2019 - 09:00
End
Friday, May 10, 2019 - 17:00
Location: Lisbon, Portugal
Booth Number: Table nr. 64

RDD Europe 2019 will be held at the Estoril Congress Center in Portugal and Hovione will be present.

 

Hovione, together with Hovione Technology will present an interactive workshop session:
 

Fully Integrated Dry Powder Solutions

  • Wednesday, May 8th | 2:00pm, 3:15pm and 4:30pm – Room F7
  • Presented by: Beatriz Fernandes, M.Sc., Eunice Costa, Ph.D., João Ventura, Ph.D.and Maria Braga, Ph.D.

This session will review traditional and advanced formulation approaches for inhalation and nasal delivery, coupling key aspects across particle engineering as well as formulation and device design. Case studies will be presented focused on the interaction between traditional carrier-based formulation components and the final outcome in terms of aerodynamic performance, manufacturability and expected lung dose. Further case studies will look at carrier-free formulations for DPIs and for nasal applications, advanced particle engineering technologies applicable to labile biomolecules and finally design optimization of a cost-effective capsule-based inhaler and device development targeting high dose delivery.
 
Hovione will also have two Communications:
 
May 9, 2019 | 11:00 am

  • Spray Drying of Inhalable Biopharmaceuticals of Increasing Size and 3D Structure Complexity: From 30 to 250 kDa (Session 4: Poster in the podium)
    Diana Fernandes, M.Sc., Hovione, Loures, Portugal

 
May 10, 2019 |11:15 am

  • Continuous Processing: Challenging the Current Manufacturing Paradigm for Dry Powder Inhalers (Session 7: New Approaches to Inhalation Product Development and Production)
    Eunice Costa, Ph.D., Hovione, Loures, Portugal

 

If you would like to discuss with us your projects and to find how Hovione can help, schedule a meeting with us. Our team will be pleased to meet you.

 

 

 

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