4.7 Article

Modelling the Compaction Step of a Platform Direct Compression Process

期刊

PHARMACEUTICS
卷 14, 期 4, 页码 -

出版社

MDPI
DOI: 10.3390/pharmaceutics14040695

关键词

process model; platform process; direct compression; formulation development; porosity; tensile strength; process optimisation; compaction; drug development

资金

  1. Pharmaceutical Manufacturing Technology Centre, an Enterprise Ireland (EI)
  2. Industrial Development Agency funding initiative
  3. EI Innovation Partnership programme
  4. Enterprise Ireland [IP20170589]
  5. Science Foundation Ireland (SFI)
  6. European Regional Development Fund [12/RC/2275-P2]

向作者/读者索取更多资源

The aim of this study was to develop statistical process models to predict tablet properties from compaction parameters, and compare and predict between different deformation characteristics and tablet press models.
The ability to predict formulation behaviour at production scale during formulation design can reduce the time to market and decrease product development costs. However, it is challenging to extrapolate compaction settings for direct compression formulations between tablet press models during scale-up and transfer from R&D to commercial production. The aim of this study was to develop statistical process models to predict tablet tensile strength, porosity and disintegration time from compaction parameters (pre-compression and main compression force, and press speed), for three formulations, with differing deformation characteristics (plastic, brittle and elastic), on three tablet press models (one pilot-scale tablet press (KG RoTab) and two production-scale presses (Fette 1200i and GEA Modul P)). The deformation characteristics of yield pressure and elastic recovery were determined for the model placebo formulations investigated. To facilitate comparison of dwell time settings between tablet press models, the design of experiments (DoE) approach was 9 individual 16-run response surface DoEs (3 formulation x 3 press models), whose results were combined to create a polynomial regression model for each tablet property. These models predicted tablet tensile strength, porosity and disintegration time and enabled the construction of design spaces to produce tablets with specified target properties, for each formulation on each press. The models were successfully validated. This modelling approach provides an understanding of the compaction behaviour of formulations with varying deformation behaviour on development and commercial tablet press models. This understanding can be applied to inform achievable production rates at a commercial scale, during the formulation development.

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