MEDELPHARM STYL’One Nano Benchtop R&D Compaction Simulator for early-stage tablet formulation

MEDELPHARM’s STYL’One Nano research and development compaction simulator provides research scientists with the compact but powerful tool needed to resolve early-stage formulation challenges in tablet and oral solid dose (OSD) manufacturing.

Apart from full and accurate powder characterization, STYL’One Nano can handle a full suite of tablet research tasks, such as screening of monolayer tablet formulations, advanced data-driven tablet formulation development, slugging of compacts, and development of analytical methods.

Powerful solution

MEDELPHARM designed the STYL’One Nano research and development tablet press to assist formulation scientists in understanding compression behavior of APIs, excipients and formulations prior to the manufacturing phase. Often research teams suffer from a lack of preliminary data to make informed decisions when making changes – to a product, to a method, to a process parameter, to a supplier – as well as limited amounts of sample powders at the development stage. In some cases, they must also cope with limited space in the laboratory working area.

The STYL’One Nano R&D Compaction Simulator solves these problems thanks to data collection and full instrumentation needed to optimize the formulation at the early stages of the tablet development. This supports a QbD (Quality by Design) methodology and allowing formulation scientists to detect and analyze complex issues such as capping, lamination, sticking, inappropriate lubrication, hardness loss, etc. at the early stages of tablet development. The ultra-compact benchtop sized design can fit in to the most cramped laboratories.

The STYL’One Nano features force and position control, independent fill height and compression thickness adjustment, along with extended dwell times in line with recently introduced USP <1062> standards, allowing product developers to achieve ideal compression profiles for new tablets.

STYL’One Nano design and engineering

STYL‘One Nano is based on a single-punch press design, which is ideal for small amounts of API and excipient at formulation stage, offering ease of operation and cleaning based on the unique and powerful MEDELPHARM drive technology.

The Nano’s flexibility allows researchers to drive punches at high velocity to replicate the pre- and main compression of a small rotary tablet press, in order to detect at the early stages possibilities of capping and other common tablet defects.

Fully instrumented with standard B&D tooling, this tableting instrument is fully software-controlled in force or position mode to capture material properties and “let your powder speak to you”.

MEDELPHARM’s proprietary ALIX data analysis software running on STYL’One Nano allows researchers to plot the recommended profiles as defined in USP <1062> and to build up their own API & excipient databases.

STYL’One Nano features and options 

The STYL’One Nano comes fully equipped to provide formulation laboratories with precise information on the powders under study and a very wide range of process options.

• Position and force driven allowing design of specific R&D compression profiles, such as V-shape or extended dwell time, for faster API characterization and formulation development. The instrument offers a choice of Force Control for tableting at specified force and quick plotting of tablet breaking force, or Position Control to mimic rotary tablet presses dynamics and to study the effect of turret speed and/or pre-compression level.
• Independent Fill Height & Compression thickness adjustments: Unlike eccentric single-punch presses, the STYL’One Nano allows fill height to be adjusted independent of the compression thickness.
• Pre- and main compression: A powerful drive technology allows accurate replication of pre- and main compression of research rotary presses at the same velocity to allow testing of pre-compression impact on formula.
• Punch force, displacement, and radial measurements: The Nano’s bottom punch velocity is double that of eccentric presses and emulates the movements on rotary tablet presses, where the lower punch applies most of the compression displacement pressure.
• Standard B & D toolings: Supports standard TSM and Euro B and D tooling of any shapes, including multi-tip.
• Choice of Profiles: The USP <1062> profiles include Saw Tooth, Square or pre-& main compression that make deep material characterization accessible.
• Uncompromised instrumentation: High resolution force and position sensors are fitted on both punches placing pre- and main compression forces, ejection force and elastic recovery at the operator’s disposal.
• Comprehensive data generation: tabletability, compactibility, compressibility, ejection stress, elastic recovery, Heckel porosity analysis, and other data can be displayed as graphs or pre-defined reports according to USP <1062>.
• On-screen control: Identical to the flagship STYL’One Evo, STYL’One Nano is entirely controlled by software and the touch screen Human Machine Interface (HMI) that allows each process parameter, such as filling height or compression thickness/force, to be precisely specified.
• Interconnection: STYL’One Nano can be connected to all automatic or semi-automatic 5-parameter hardness testers to transfer testing data on breaking force, thickness, length, width, mass, etc. to software.
• Integrated characterization standards: STYL’One Nano Alix software natively integrates USP <1062> tablet characterization standards to make manufacturability profiles (tablet breaking force vs compression force) or tableting profiles (tensile strength vs pressure) readily available. Compressibility and compactibility profiles are also available when powder true density is known.
• Compact & mobile, with small footprint: This compact table-top unit can be installed on an existing bench, on its optional mobile base or inside a low-rise booth.

Resources

Click on MEDELPHARM Instruments for more information on hardware and software.
Click on MEDELPHARM STYL’One Nano to download brochure.
Click on STYL’One Nano R&D Benchtop Tablet Press for YouTube video.