MEDELPHARM STYL’One Evo Compaction Simulator for secure tablet development and scale-up

MEDELPHARM’s STYL’One Evo R&D Compaction Simulator provides an all-in-one solution to the needs of tablet development teams, from early API characterization and powder formulation to final development and scale-up to high-speed production.

The STYL’One Evo is a multi-functional R&D press that can gather data to assess formulation behavior and tabletting characteristics, mimic a whole range of tabletting presses, and produce pilot batches of tablets.

Meeting industry needs

Incorrect powder formulations and tabletting parameters can create significant issues that arise during tablet production on industrial rotary presses, ranging from high proportion of defective tablets or need to stop production to troubleshoot formulation problems that cause expensive delays, high wastage and prolonged time to market.

The STYL’One Evo answers these challenges by supporting a data-driven Quality by Design (QbD) approach during development that avoids need for subsequent troubleshooting at the manufacturing stage. It thus provides an essential tool for assessing the overall suitability and robustness of the powder formulation and early detection of potential problems that might occur during full-scale production on high-speed rotary presses, including sensitivity to speed or heat, sticking, picking, capping and delamination.

STYL’One Evo design and features

STYL’One Evo is above all designed for precision and versatility. At the core of its single punch design are twin planetary roller screws and powerful torque engines that allow it to mimic the exact kinetics (position, speed and acceleration) of the punch movement of a rotary tablet press, as well as replicate relaxation between rolls, at various speeds.

It can generate punch velocities up to 490 mm/s, with acceleration of 2.6G, to match those typically found on front-line rotary tablet presses at high rotation speeds. The simulator is designed to be used in conjunction with the bundled ANALIS data analysis software platform that includes an extensive database library of more than 100 commercially available tablet presses, including those from industry leading sister company KORSCH AG, as well as Fette, Courtoy, etc.

STYL’One Evo advantages

The STYL’One Evo design features allow this simulator to give a far more accurate picture of the impact of speeds on powder behavior when it comes to scale-up and make it the most versatile single-punch tablet press for scale-up and production support, providing users with an array of tangible benefits:

• Powerful yet easy-to-use with an intuitive control interface integrated with full instrumentation and data analysis via ANALIS operating system software package.
• Compact working area that is easy to clean and lends itself to fully isolated applications.
• Economical, needing only a few grams of powder to fully test formulation and tablet behavior during scale-up and roll compaction mimicking for ultimate material sparing.
• Fully functional pilot press for production of test and proving tablet batches, including multilayer formats.
• Fully instrumented “tabletting robot” that can fully explore the QbD design space (QbD) and analyze any formula with utmost efficiency.
• High flexibility with many modules and accessories to fit specific needs, including safety/isolation options for High Potency APIs and GMP guidelines and GMP production software module with automatic weight regulation and tablet rejection system as well as external lubrication option for cGMP production.
• Target thickness settings to mimic any rotary tablet press.
• Powerful software platform: User-friendly Analis software can be installed on a laptop or desktop PC to control STYL’One Evo, while collecting and analyzing generated data against USP<1062> benchmarks for manufacturability, tabletability, compressibility and compactibility. Customized plots for any data parameters are easily developed to explore porosity, ejection stress, elastic recovery, etc.
• Tabletting versatility: able to develop multi-layer tablets with up to three formulations in five layers and automatic core feeding system for tab-in-tab.

STYL’One Evo is also backed by global MEDELPHARM’s Science Lab and KORSCH INNOVATION CENTERS advanced laboratory expertise and consulting services to provide a full range of R&D, scale‑up and production support solutions.

Resources

Click on MEDELPHARM Instruments for further information.
Click on STYL’One Evo Compaction Simulator to download brochure.
Click on STYL’One Evo: Most versatile compaction simulator to watch YouTube video.
Click on MEDELPHARM YouTube video channel for further resources.