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Multivariate Data Analysis to Assess Process Evolution and Systematic Root Causes Investigation in Tablet

Rita Mathe1, Tibor Casian1, Ioan Tomuta1

  • 1Department of Pharmaceutical Technology and Biopharmacy, "Iuliu Hatieganu" University of Medicine and Pharmacy, 400012 Cluj-Napoca, Romania.

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|February 26, 2025
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Summary
This summary is machine-generated.

This study identified key variables impacting tablet hardness in high-shear wet granulation, leading to improved product quality and reduced variability. Optimized process conditions ensure robust tablet hardness, enhancing manufacturing efficiency and yield.

Keywords:
active ingredient variabilitybatch modelinghardness improvementmultivariate data analysisroot causes investigationtablet manufacturing

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Analytical Technology (PAT)
  • Quality by Design (QbD)

Background:

  • Limited industrial-scale studies address input variability's impact on product quality in non-simulated conditions.
  • Investigating root causes of low and variable tablet hardness in high-shear wet granulation is crucial.

Purpose of the Study:

  • To identify root causes of low and variable tablet hardness using batch statistical modeling.
  • To verify the effectiveness of improvement actions for tablet hardness.

Main Methods:

  • Utilized multivariate methods for complex data assessment at an industrial scale.
  • Analyzed data from two proportional composition strengths with varying tablet shapes and sizes.
  • Identified inter-related active ingredient and process variables impacting hardness.

Main Results:

  • Identified four critical variables: API particle size, granulation nozzle type, wet discharge, and drying intensity.
  • Developed an updated control strategy with specific ranges for these variables.
  • Demonstrated ability to accommodate wider API particle size (d0.5 up to 70 microns) while maintaining adequate tablet hardness.

Conclusions:

  • Reduced risk of out-of-specification hardness results.
  • Achieved cost avoidance and yield improvement.
  • Confirmed significant average hardness increase (15-20%) and decreased batch variability, reaching sigma quality levels of 2.5.