Press Room

2016 AIChE Annual Meeting

Start
Sunday, November 13, 2016 - 00:00
End
Friday, November 18, 2016 - 00:00
Location: San Francisco, United States
Cocrystals amorphous solid dispersions | Hovione

HOVIONE PRESENTATIONS

1. Multi-Scale Modeling in Pharmaceutical Drug Substance Manufacturing
José L.C. Santos, Rui C. Silva and Filipe A.P. Ataíde
Date: Monday, Nov 14
Presentation Time: 12:30 PM
Location: Continental 5 (Hilton San Francisco Union Square)

2. Evaporation of Binary Mixtures and Shell Formation in Spray Dried Droplets
Pedro Valente, Íris Duarte, Tiago Porfirio, Xu Liu, Feng Zhang and Márcio Temtem (in collaboration with University of Texas)
Session: Tools for Accelerating Pharma Development and Innovations in Biopharmaceutical Discovery, Development, and Manufacturing 
Date: Tuesday, Nov 15
Presentation Time: 1:58 PM - 2:20 PM 
Location: Continental 5 (Hilton San Francisco Union Square)

3. Evaluating Mixing Performance in a Stirred Tank Reactor with Different Impeller Geometries and Reactor Size By CFD
Rui C. Silva
, Filipe A.P. Ataíde and José L.C. Santos
Date: Wednesday, Nov 16
Presentation Time: 8:30 AM
Location: Union Square 1 & 2 (Hilton San Francisco Union Square)

4. Scale-up of Reaction and Crystallization Steps of a Commercial Manufacturing Process in a Multi-Purpose Plant Using Mechanistic Modeling 
Filipe A.P. Ataíde, Rui C. Silva and José L.C. Santos
Date: Thursday, Nov 17
Presentation Time: 10:15 AM
Location: Continental 4 (Hilton San Francisco Union Square)

5. Secondary Drying Scale-up Methodology: Eliminating a bottleneck with a Lean Development Approach
Tiago Porfirio, Pedro Valente, Ines Matos, Jorge Moreira, João Vicente, Márcio Temtem and Viriato Semião
Session: Quality By Design in Drug Product Formulation, Design, & Process Development I 
Date: Thursday, Nov 17
Presentation Time: 1:08 PM - 1:27 PM 
Location: Continental 4 (Hilton San Francisco Union Square)

 

HOVIONE POSTERS at POSTER SESSION

Date: Monday, November 14, 2016
Session Time: 3:15 PM - 5:45 PM
Location: Grand Ballroom B (Hilton San Francisco Union Square)

 

1. Modelling Approaches to Spray Drying Process Development, Scale-up and Troubleshooting
Pedro Valente, Íris Duarte, Filipe  Neves and Márcio Temtem

2. Predicting the In Vivo Performance of Amorphous Solid Dispersions Based on Molecular Descriptors and Statistical Analysis
Íris Duarte, João Henriques, João F. Pinto, Márcio Temtem

 

Contact us if you would like to schedule a meeting or to find more about the Hovione presentations at 2016 AIChE Annual Meeting.

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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