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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.

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

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.

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.

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
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
Rotary
Simulation

A QbD approach to shorten development time

Reducing “time to market” is the ultimate goal for every pharmaceutical lab. Being the fi rst on the market brings a competitive advantage for prescription, over-the-counter, or generic-drug manufacturers.

Applying quality-by-design (QbD) principles at the formulation phase can prevent tablet defects at an early stage and thereby drastically reduce time during the complex and troublesome phase of “scale-up.”

Energetics Approach

In physics, a force is said to do work if, when acting, there is a displacement of the point of application in the direction of the force.

This bulletin describes the different Work of Forces that are automatically calculated by STYL'One software. Those Works are named Plastic & Elastic energies in Analis. Somes authors use other terminologies, such as Net Energy, Work of Compression (Wc), Work of Decompression (Wd) and Work of Compression+Decompression (Wc/d).


Integrals
Joules

Comparison of the Performance of Single Punch and Rotary Tablet Presses from Different Vendors

As tablets are the most common dosage form for drug delivery, many different rotary presses are available on the market in order to produce tablets with a high throughput. Single punch presses are used for pharmaceutical development or to simulate the compaction process using small material quantities. In this study, 5 different rotary presses and 4 single punch presses were utilized using 3 different model formulations. Tablet masses and tensile strengths were investigated as a function of compaction force and process time.

force-time profiles
rotary tablet presses
single punch tablet presses
tensile strength

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