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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Scaling up direct compression tablet formulations presents challenges in predicting compaction behavior across different tablet press models.
  • Extrapolating settings from R&D to commercial production can lead to delays and increased costs.
  • Understanding formulation deformation characteristics (plastic, brittle, elastic) is key to successful scale-up.

Purpose of the Study:

  • To develop statistical process models for predicting tablet tensile strength, porosity, and disintegration time.
  • To evaluate these models across three different tablet press models (pilot and production scale).
  • To enable the creation of design spaces for producing tablets with specific target properties.

Main Methods:

  • Utilized a design of experiments (DoE) approach with response surface methodology.
  • Investigated three model placebo formulations with distinct deformation characteristics.
  • Developed polynomial regression models by combining data from multiple DoEs across different tablet presses.

Main Results:

  • Successfully developed predictive models for tablet tensile strength, porosity, and disintegration time.
  • Enabled the construction of design spaces for achieving desired tablet properties on specific presses and formulations.
  • Validated the predictive accuracy of the developed statistical models.

Conclusions:

  • The developed statistical modeling approach accurately predicts tablet properties during scale-up.
  • This methodology enhances understanding of formulation compaction behavior on various tablet press models.
  • Informed production rate optimization and reduced time-to-market for pharmaceutical formulations.