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Application of Failure Mode Effect Analysis in Wurster-Based Pelletization Technology: a Technical Note.

Aarti Patel1, Asha Patel2, Rakesh Patel2

  • 1Department of Pharmaceutics, Parul Institute of Pharmacy, Parul University, P.O. Limda, Ta: Waghodia, Vadodara, Gujarat, 391760, India. patelasha1405@gmail.com.

AAPS Pharmscitech
|October 27, 2019
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Summary

This review explores variables in Wurster coating for oral multi-unit pellet formulations. It highlights using Failure Mode and Effects Analysis (FMEA) to identify critical factors for robust drug product development.

Keywords:
Wurster technologyfailure mode effect analysisfluidized bed coatingpelletsrisk assessment

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Process Engineering

Background:

  • Oral multi-unit pellet formulations are increasingly used for modified release and acid resistance.
  • Fluidized bed coating, particularly the Wurster technique, is vital for pellet manufacturing but involves complex, numerous variables.
  • Developing robust pellet formulations requires identifying and controlling critical process parameters.

Purpose of the Study:

  • To comprehensively review variables involved in the Wurster coating process for pellet manufacturing.
  • To demonstrate the application of Failure Mode and Effects Analysis (FMEA) in identifying critical factors for robust pellet production.
  • To illustrate how risk assessment tools can optimize development by reducing experimental trials.

Main Methods:

  • Literature review of variables in Wurster coating processes.
  • Application of Failure Mode and Effects Analysis (FMEA) as a risk assessment tool.
  • Case study illustrating FMEA's use in analyzing critical factors for pellet manufacturing.

Main Results:

  • Identification of numerous variables influencing Wurster coating outcomes.
  • Demonstration of FMEA's capability to screen critical parameters from a large set.
  • Case study showing reduced trials through risk assessment in pellet development.

Conclusions:

  • Risk assessment tools like FMEA are effective in managing complexity in Wurster coating.
  • Systematic identification of critical variables using FMEA aids in developing robust oral pellet formulations.
  • FMEA facilitates optimized product development by reducing the number of necessary experimental trials.