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Material Characterization with a V-shape compression profile on STYL'One Nano

In the early stages of drug development, APIs are often available in limited amount. However, scientists have to foresee the impact of compaction parameters on tablet attributes. In fact, tablet quality such as its hardness depends on several process parameters including the compression speed, pressure and profile used.

Compaction simulators, such as the STYL’One Nano, can easily explore compression dynamics and allow researchers to deeply understand their powder with only few grams of material. This avant-garde technology is key for fundamental material characterization and deep understanding of their product.

The goal of this bulletin is to dive into the V-shape compression cycle available on STYL’One Nano and to demonstrate its usefulness in powder characterization with real speed sensitivity practical examples.

Material Science
STYL'One Nano
V-shape compression cycle
compaction parameters
compression profile
material characterization
speed sensitivity

Material Characterization with Extended Dwell Time Compression Profile on STYL'One Nano

During the development of a new drug, active materials are often available in small quantities for cost or process reasons. However, scientists have to understand their deformation behavior to design the best formulation possible and find suitable process parameters for production.

Compaction simulators, such as the STYL’One Nano, can easily explore compression dynamics and allow researchers to deeply understand their powder with only few grams of material. This premium technology is key for fundamental material characterization and deep understanding of your powder.

The goal of this bulletin is to dive into the Extended Dwell Time cycle available on STYL’One Nano and to demonstrate its usefulness in powder characterization with real practical examples.


Dwell time
Process parameters
STYL'One Nano
compression profile
deformation behavior

Effect of binder particle size on tablet performance

Binders play a crucial role to ensure acceptable tablet hardness and low friability in direct compression and dry granulation processes. Among all dry binders, low molecular weight hydroxypropyl cellulose (HPC) is the most effective due to its outstanding plasticity. In addition to plasticity and molecular weight, the particle size of the binder can have a considerable effect on its binding capacity. Finer particles may fill the interstitial voids between large particles of the blend, and may exhibit increased toughness and therefore, result in harder tablets. The objective of this study was to evaluate the effect of different types and grades of plastic polymeric binders including HPC and microcrystalline cellulose (MCC) on tablet strength in direct compression and dry granulation processes.

Ashland
hydroxypropylcellulose
klucel™

Material Characterization on STYL'One Nano

Excipients, APIs or formulations can be processed in different ways, thus resulting in different properties. Research has been performed to improve powder properties including powder flow, powder density, particle size distribution and particle shape.

In the case of tableting, these improvements are crucial to guarantee optimal tablet properties, production yield and high production output. 

This case study illustrates how STYL’One Nano can be an efficient tool for scientists to demonstrate material properties, securing their formulation development and their product marketing.

Mannitol
Medelpharm
STYL'One Nano
characterization

Replacing the lubricants stearic acid or magnesium stearate with lubricants based on natural ingredients.

The following data shows a comparison between conventional lubricants (stearic acid / magnesium stearate) and natural based lubricants (rice extract) or excipient premixes (cellulose/rice extract/oil/wax). By working with natural ingredients it would be possible to label your product cleaner than other chemical-sounding words.

The natural lubricant which was used for trials is a vegetable rice extract from RIBUS, a manufacturer of specialty ingredients. Nu-RICE® is a patented hypoallergenic extract from rice bran. This natural processing aid helps hydrate, lubricate and emulsify ingredients to create easier and faster processing.

Biogrund
CompactCel®
Nu-RICE®
comparison
lubrication
natural ingredients

A targeted force in study mode on Analis software

This bulletin explains why you might experience differences between your target force and output force on your STYL’One Evo.

It also presents solutions to improve your system response and be as close as possible to your target force

Medelpharm
controller
powder rearrangement
target force

STYL'One Evolution / Industrial rotary press correlation study on a tab-in-tab dosage form

This case study was presented by SKYEPHARMA during CSF Cambridge 2018 to highlight the development of multilayer and tab-in-tab dosage forms on STYL’One Evo while saving time and cost during the development phase.

Controlled release forms are more complex to design but very interesting to deliver a sustained API dose or a delayed pulse of API to the patient.

Skyepharma
controlled-release
cost saving
industrial rotary tablet press
multilayer
tab-in-tab
time saving

Roller Compactor Hybrid Modelling

Any mathematical model needs to be compared with experimental data. The thin-layer model used within Analis software is no exception. Analis provides a good approximation of the Specific Compaction Force (or Hydraulic Pressure) of a mimicked roller compactor. However, this model requires to be calibrated with a given brand and model with a Kp coefficient.

Medelpharm
dry granulation
roller compaction
stylone

Characterization guidelines

This document describes some best practices in characterizing pharmaceutical powder (API / Excipients).

It reviews the following topics:


Tabletability / Manufacturability Profiles, Ejection Force / Ejection Stress, Transmission Ratio, Strain Rate Sensitivity, True Density measurement (Helium Pycnometer), Compressibility Modelling, Compactibility Modelling, Work of compression, Radial Stress

Material Science
Medelpharm
USP <1062>

Rotary Tablet Press Mimicking

The following case studies were performed to show that tablets made on STYL’One Evo and tablets made on industrial-size rotary tablet presses exhibit the same characteristics, in terms of Tablet Breaking Force (Hardness), but also in terms of Dissolution Profiles.

Dissolution
Hardness
Medelpharm
Rotary
Simulation

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