MEDELPHARM White Paper: Material characterization using extended dwell time compression

The latest White Paper bulletin from research-based manufacturer and powder compaction specialists explores how extended dwell time profiles allow scientists to identify different viscoplastic and viscoelastic behaviors in excipients, and how different studies can be easily performed on the STYL’One Nano benchtop research press to optimize formulation for tableting.

The bulletin Material characterization with an extended dwell time compression profile on STYL’One Nano is based on studies carried out in the MEDELPHARM Science Lab by formulation Scientist Sixtine Caquant and Product Marketing Manager Quentin Boulay.

Particle deformation

The bulletin is designed to meet the needs of formulation scientists and researchers to gain deeper understanding of particle deformation behavior to optimize formulations and process parameters using the smallest possible quantities of active ingredient.

Compaction simulators, such as the STYL’One Nano, can easily explore compression dynamics and allow researchers to deeply understand powder properties using only a few grams of material. The bulletin provides full explanation of how the Extended Dwell Time cycle available on STYL’One Nano can be used to evaluate powder viscoelasticity/viscoplasticity in powder characterization with real practical examples.

Detailed studies

Monograph 1062 of the US Pharmacopeia (USP) defines Extended Dwell Time profile as “square punch displacement–time profile”. The dwell time is the period during which a punch is static throughout the compression cycle. Having the capability to modify this dwell time in the range of 1 ms to 3 000 ms with the Extended Dwell Time profile will allow scientists to define the viscoelasticity/viscoplasticity behavior of their powders, which can contribute to forming the tablet.

The bulletin studies the deformation behaviors of three well-known excipients: microcrystalline cellulose grade 105 (MCC), partially pregelatinized starch (starch), and di-calcium phosphate (DCP) and how they are affected by dwell time. The study finds that viscoplastic and viscoelastic materials like MCC or starch keep rearranging during the extended dwell-time, whereas DCP does not exhibit this trend.

STYL’One Nano benefits

By combining study results with energy calculation and manufacturability profile, formulation scientists are given better data to design the best formulation based on the behaviour of their APIs and excipients.

The bulletin shows how STYL’One Nano’s features and benefits can directly aid powder characterization and formulation development, allowing researchers to:

• Understand API/excipient compression behavior (plastic, elastic, brittle, etc.)
• Offer improved performances (tableting properties, lubrication effect, etc.)
• Find optimal formulation to meet tablet quality attributes (hardness, dissolution, disintegration, friability, etc.) and cost target
• Explore process parameters (dry granulation, wet granulation, drying, milling, compression, etc.) and their impact on tablet quality attributes
• Save time and money during development

Resources

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