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Press Clipping / Feb 08, 2018

Hovione Researcher on month-long study visit to ISAB Labs

LAB BLOG: Inhalation Sciences, February 8, 2018

Hovione Researcher on month-long study visit to ISAB Labs | Hovione

Hovione doctoral researcher Beatriz Noriega returns to ISAB’s labs in Stockholm for her ongoing research into preclinical in vitro dissolution testing. She talks to Lab Blog about why she believes dissolution testing is critical, and how she’s hoping to prove it.

 

Hovione Ph.D. researcher Beatriz Noriega has been working for two years so far on her doctoral thesis, authoring four well-received posters and with two accepted for the next Respiratory Drug Delivery (RDD) Conference in April 2018. This is Beatriz’s second research visit to ISAB’s labs to use the in vitro simulation tool DissolvIt, as part of her work in the Particle Design and Inhalation Development department of Hovione’s R&D Drug Product Development. Her mission? “No matter how similar formulations may seem, until you analyze dissolution you never really know,” says Beatriz. She took time out from her research to talk to our ISAB Lab Blog.

 

 

Read the entire interview at Inhalation.se

 

 

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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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