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.

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

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.

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.”

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).

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.

All what you need to know about the size & format of Punches & Dies.

Some terminology such as D, B, 441, EU, TSM + a list of Punches & Dies compatible with STYL'One Evolution.

In this article, Aline Moulin, PhD, Head of the New Product Introduction Department, and Lucile Kowalski, PhD, Pharmaceutical Development Project Manager, both of Skyepharma, examine two case studies comparing compaction simulation with industrial compression.

Why an internal play?

On rotary tablet presses with multilayer capabilities, just after the fill of the second blend, the first and second layers are pushed down by the upper punch.

On STYL’OneEvolution, the “internal play” on the lower punch aims at mimicking this very process.

When the upper punch is going down for compaction, it pushes the powder bed and the lower punch at the same time, the latter one being only retained by the punch break.

This case study aims at showing that compaction simulation can be used as a QbD tool to develop complex oral solid dosage forms, at any step of development (prototyping, scale-up, manufacturing optimization) and in particular for complex oral solid dosage forms (tab in tab, multi-layer tablet)