Press Room

Webinar - One - fruitful - long shot: extended release approaches for small and large molecules

Start
Wednesday, November 25, 2020 - 16:00
End
Wednesday, November 25, 2020 - 16:00
Location: online

 

Wednesday, November 25th, 2020
4:00pm GMT   |   11:00 am EDT  |   5:00 pm CEST

 

Registrations to the webinar are subject to approval

 

 

Speakers

Cláudia Moura, PhD - Senior Scientist, R&D Drug Product Development
Teresa Marta, MSc - Associate Analytical Chemist, R&D Analytical Development

 

Drug-delivery systems administered by injection that allows controlled-release are highly desirable due to the reduced frequency of administrations that can range from weeks to months or even years, increasing patient compliance while providing the same therapeutic efficiency.

In this webinar, we will address insights into the formulation and available particle engineering technologies for controlled delivery of small molecules and biopharmaceuticals using Poly(lactic-co-glycolic) Acid (PLGA) as biodegradable polymer. We will also explore standard and advanced material characterization techniques including accelerated in vitro release (IVR) methods which have received considerable attention to expedite time required for batch release. 

This webinar will present Hovione’s approach for controlled release PLGA formulations throughout the manufacturing process and product characterization. You can hear about several manufacturing techniques available at Hovione that are followed by case-studies; the analytical characterization will also be showcased focusing on real time and accelerated IVR.

 

What can you learn from this webinar?

  • Controlled release systems - delivery routes
  • Formulation and manufacturing approaches

 

 

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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

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