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Streamlining tablet lubrication design via model-based design of experiments.

Francesca Cenci1, Gabriele Bano2, Charalampos Christodoulou3

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Summary

A new model-based design of experiments (MBDoE) approach optimizes powder lubrication selection for direct compression tablet manufacturing. This method significantly reduces experimental effort and material consumption while ensuring quality.

Keywords:
Lubrication modelModel-based design of experimentsOral solid dosage formParallel designParameters identifiabilitySequential design

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Area of Science:

  • Pharmaceutical Sciences
  • Chemical Engineering
  • Materials Science

Background:

  • Powder lubrication is critical in direct compression tablet manufacturing to ensure manufacturability and quality.
  • Existing semi-empirical models, like the Kushner and Moore model, require extensive experimental data for parameter identification.
  • This extensive experimentation leads to high consumption of Active Pharmaceutical Ingredient (API) and significant time investment.

Purpose of the Study:

  • To introduce a novel model-based design of experiments (MBDoE) approach for optimizing powder lubrication selection.
  • To minimize the number of powder blends needed for model calibration and parameter estimation.
  • To compare the efficacy of sequential and parallel MBDoE configurations.

Main Methods:

  • Development and application of a model-based design of experiments (MBDoE) approach.
  • Calibration of lubrication models using a reduced number of experimental blends.
  • Comparison of sequential and parallel MBDoE strategies.
  • Experimental validation using placebo blends with varying lubrication sensitivity.

Main Results:

  • The proposed MBDoE methodology significantly reduces experimental effort by 60-70% compared to standard practices.
  • Statistically sound parameter estimates and model predictions were achieved with minimized experimental runs.
  • The reduction in experimental effort was consistent across different formulations and MBDoE configurations (sequential vs. parallel).

Conclusions:

  • The novel MBDoE approach offers a more efficient and resource-sparing method for selecting optimal powder lubricants in direct compression.
  • This methodology streamlines the tablet manufacturing process by reducing API consumption and experimental time.
  • MBDoE provides a robust framework for model calibration and prediction in pharmaceutical powder formulation.