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Particle Agglutination Method for Poliovirus Identification

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Published on: April 20, 2011

Quality by Design (QbD) based process optimisation to develop functionalised particles with modified release

Eman Z Dahmash¹, Ali Al-Khattawi¹, Affiong Iyire¹

¹Aston School of Pharmacy, Aston University, Birmingham, United Kingdom.

|November 2, 2018

Summary

Quality by Design (QbD) optimizes pharmaceutical dry particle coating. This systematic approach efficiently improved particle functionality, content uniformity, and dissolution rates, demonstrating QbD

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Area of Science:

Pharmaceutical Science
Chemical Engineering
Materials Science

Background:

Quality by Design (QbD) is a systematic approach to pharmaceutical development.
It emphasizes designing quality into products and processes from the outset.
Dry particle coating is a key technology for modifying particle functionalities.

Purpose of the Study:

To apply QbD principles for optimizing dry particle coating process parameters.
To enhance the production of particles with modified functionalities.
To identify optimal process conditions for improved product attributes.

Main Methods:

Utilized Quality by Design (QbD) principles for process optimization.
Conducted an initial risk assessment to identify critical process parameters.
Employed Design of Experiments (DOE) with MODDE software and a D-optimal design.
Analyzed effects on content uniformity, dissolution rate, particle size, and FTIR spectra.

Main Results:

Batch size significantly impacted dissolution rate, particle size, and FTIR intensity.
Increased batch size enhanced dissolution, reduced particle size, and increased FTIR intensity.
Content uniformity was influenced by interaction terms, notably speed and batch size.
Optimal conditions included maximum air pressure, low batch size, specific speed ranges, and processing times.

Conclusions:

QbD provides an effective and cost-efficient method for pharmaceutical process development and optimization.
The study successfully defined an optimal design space for producing functionalized particles.
The QbD model demonstrated reliability and predictive capability for process validation.