MEDELPHARM White Paper: Material Characterization on STYL’One NANO

Research-based manufacturer and powder compaction specialists MEDELPHARM has produced a further White Paper bulletin detailing a research case study carried out using a STYL’One Nano benchtop research instrument to reveal influence of Mannitol grades on tablet hardness.

The paper, authored by STYL’One Product Marketing Manager Quentin Boulay and MEDELPHARM Science Lab Head Dr. Bruno Leclercq, investigates the effects of Mannitol production processes and particle size distribution on tablet properties.

Influence of different grades and particle sizes

The STYL’One Nano compaction simulator was used to produce tablets at different forces ranging from 5 to 25 kN, using a standard EU-B 11.28-mm round flat tooling and a V-shape research compression profile to ensure constant speed of the punch during the compaction process.

The study confirms that Mannitol produced by a spray dried process exhibits higher tablet strength compared to crystalline grades at equivalent particle size.

More surprising, the paper demonstrates that particle size plays a more influential role on tablet hardness, with finer grades of Mannitol producing harder tablets. Decreasing particle size of the crystalline grades also had an influence on manufacturability, with an increase on total surface area, combined with a higher plastic energy, resulting in an increase in tablet hardness due to higher cohesion between particles.

Harnessing STYL’One Nano abilities

The study highlights key benefits of the STYL’One Nano in laboratory use, allowing impact of formulation process changes to be assesses quickly, using only a few grams of material.

The STYL’One Nano allows researchers to assess:

• Impact of granulation process parameters on tablet properties
• Influence of milling conditions on quality attributes
• Effect of mixing conditions on tablet properties
• Approval of a new excipient/API supplier

Other benefits include:

• Compact & mobile
• Standard tooling
• Quick product or tooling changeover
• Easy to clean and handle
• Intuitive HMI for fast experiment setup and results

STYL’One Nano capabilities can be further expanded with additional Alix software modules, along an external lubrication system.

Resources

Click on MEDELPHARM Science Lab for more information.
Click on MEDELPHARM Instruments  for further resources.