CSF. Compaction Simulator Forum Tablet Presses, Compaction Simulators What does the future hold?
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1 CSF Compaction Simulator Forum 2012 Tablet Presses, Compaction Simulators What does the future hold? Jean LeFloch Huxley Bertram servohydraulic compaction simulators 14 November 2012 Cambridge, MA
2 Structure and Themes 1. Tablet Presses, Compaction Simulators 2. Simulators and Compaction Research 3. Integrated Compaction Research/Simulation Systems 4. What does the future hold? Themes not much happening with tablet presses a lot happening with simulators simulator>integrated simulation/research platform collaboration is the path to success a timeline 2
3 1. Tablet Presses, Compaction Simulators Timeline 1843 Brokendon patent rotary presses: 36,000 tabs/hr (Burroughs & Wellcome) 1938 invention of the strain gauge 1945 Takeru Higuchi ( father of physical pharmacy ) Wisconsin and Kansas 1946 Hindman & Burr, first material testing machine 70/76 first hydraulic simulators (UK and Basel) 60/80 complex compacts (dry coating and bilayer) nd generation servohydraulic simulators (UK) 1980s 1990s first presses with removable turrets; fully-computerised presses complex compacts, modern designs (tablet presses) rd generation servohydraulic simulators 2012 CSF2012 3
4 1. Tablet Presses, Compaction Simulators Tablet press developments, centrifugal die-feeding and Wash-in-Place 2000 Exchangeable Compression Module equal porosity tableting (re-launch) 2000 advanced, modular platforms for complex compacts 2005 from discrete dies to die plates 2010 increased tooling stations density direct compression, 3 rolls single-chamber feeder 4
5 1. Tablet Presses, Compaction Simulators Recent innovations centrifugal die-feeding, down-ejection equal porosity tableting (hybrid control) segmented turret instead of individual dies exchangeable die disc; die shells 12 mm punches (25 kn), 87 stations, single-sided 550 mm PCD turret at 120 RPM, tablets/hr direct compression, 3 pressure rolls ( kn) mini-micro tablets (multiparticulates, multi-tipped tooling) advanced, modular presses for complex compacts 5
6 1. Tablet Presses, Compaction Simulators Multi-tipped tooling for minitablets UNDERCUT DEPTH courtesy of Elizabeth Carbide Die Co., Inc. 6
7 1. Tablet Presses, Compaction Simulators Tablet presses status a very stable technology (unit operation) emphasis on complex compacts no drastic process-related evolution or revolution multi-sourced equipment, Europe & Asia vendors compete on versatility, containment, WiP, output, changeover, support a return to single-sided presses is external lubrication the Next Big Thing? 7
8 1. Tablet Presses, Compaction Simulators External lubrication originated in the early 90s? lubricant is sprayed onto the die and punch tips no lubricants in the formulation multiple advantages, functional and operational desirable for continuous tableting trains approaches: solvent-based dry, sprayed electrostatic, corona discharge (JP) applicability to roller compaction? not reliable at production scales; maturity expected in
9 2. Simulators and Compaction Research Areas of research: structures, properties, performance, characterisation, process we have only scratched the surface! post-dwell behaviour in-die analytics thermodynamics/temperature adherence/sticking de-aeration tri-axial testing friction feeding/deposition humidity lubrication, internal/external punch tip shape/design batch/continuous punch head (optimisation & harmonisation) microstructures (Eurostandard, ISO, TSM/IPT) tip/tablet interaction complex compacts chip-in-tablet extrudates, HME microcracking modelling viscoelasticity anisotropy 9
10 2. Simulators and Compaction Research Complex compacts 10
11 3. Integrated Compaction Research/Simulation Systems Extension of the simulation scope to other unit operations roller compaction: simulation or mechanical emulation by pseudo-rolls? formal approach, libraries advanced features (deaeration ) lubrication (internal/external) Fitzpatrick, Alexanderwerk, Gerteis roller compaction, simulation or mechanical emulation (pseudo rolls) encapsulation (if required by marketplace) low-force powder compression physics two approaches tamp-filling design (Germany) dosator nozzle design (Italy) 11
12 3. Integrated Compaction Research/Simulation Systems Integration integration of simulation and research functionalities integration of analytical and characterisation functions in-die on-simulator at-simulator in-lab out-of-lab integration of information and knowledge internal/external data bases excipients data bases experimental information (experiment, real-time data, analytics, characterisations) knowledge management 12
13 4. What does the future hold? 2012 assessment, planning first CSF 2013 presses & simulators parity/alignment prioritisation of the research/characterisation directions extension of the simulation focus CSF presses with external lubrication research/characterisation hybrid compacts modelling CSF knowledge management research/characterisation modelling CSF
14 4. What does the future hold? Development steps (subject to market directions) 2012 usability improvements minitablets instrumentation hybrid control (1) 2013 usability improvements complex compacts hybrid control (2) hybrid control (3) roller compaction simulation external lubrication (simulators) 2014 analytics/characterisation hybrid compacts modelling 14
15 4. What does the future hold? Rational design and compaction simulators Rational design is: material-sparing, small-scale methods, mini-piloting, science of scale.. rapid science-based multidisciplinary and collaborative based on previous and formal knowledge reliant on simulation & modelling (in-silico and physical) The most effective contributors to pharmaceutical sciences in the 21st century.will benefit from a fundamental understanding of the properties of pharmaceutical materials. Pharmaceutical Materials Science focuses on connecting phenomena that occur at a molecular and microscopic scale to macroscopic performance. Gregory E. Amidon, Ph.D. 15
16 4. What does the future hold? Tableting evolution 16
17 4. What does the future hold? Conclusion tablet presses: stability, complex compacts, external lubrication simulators: parity with presses, then focus on advanced research feature from simulator to research/simulation/knowledge platform collaboration is the path to success 17
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