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A quality by design framework for developing nanocrystal bioenabling formulations.

Ana Simões1, Ricardo A E Castro2, Francisco Veiga1

  • 1Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal; Associated Laboratory for Green Chemistry of the Network of Chemistry and Technology (LAQV/REQUIMTE), Group of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, 3000-548 Coimbra, Portugal.

International Journal of Pharmaceutics
|September 17, 2023
PubMed
Summary
This summary is machine-generated.

This study developed a stable hydrocortisone nanocrystal formulation using high-pressure homogenization and Quality by Design. The optimized formulation shows enhanced skin permeation and drug release, offering a promising "green" approach for drug delivery.

Keywords:
Central composite designCrystallinityNanocrystalsPerformancePhysical stabilityQuality by designSolid-stateTopical dermatological product

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Area of Science:

  • Pharmaceutical Nanotechnology
  • Drug Delivery Systems

Background:

  • Developing stable and effective topical formulations for drugs like hydrocortisone is crucial for improving therapeutic outcomes.
  • Nanocrystal technology offers a promising avenue for enhancing drug solubility, bioavailability, and skin permeation.

Purpose of the Study:

  • To design and optimize a 1.0% hydrocortisone nanocrystal formulation using a scalable high-pressure homogenization (HPH) technique.
  • To apply a Quality by Design (QbD) approach to ensure a robust and reproducible manufacturing process.
  • To improve skin permeation and stability of the hydrocortisone formulation.

Main Methods:

  • Utilized high-pressure homogenization (HPH) for nanonization of hydrocortisone.
  • Employed a Quality by Design (QbD) approach, including Failure Mode, Effects and Criticality Analysis (FMECA) and a central composite design (CCD).
  • Investigated the impact of squalene concentration, soluplus concentration, and HPH time on critical quality attributes (CQAs).

Main Results:

  • Achieved hydrocortisone nanocrystals with optimal particle size (311.8 nm) and narrow distribution.
  • Demonstrated enhanced in vitro drug release rates and improved permeation flux across the skin compared to conventional forms.
  • Defined a robust Design Space (DS) for critical process parameters, ensuring formulation stability and performance.

Conclusions:

  • The developed hydrocortisone nanocrystal formulation, produced via an organic solvent-free HPH method, exhibits superior physicochemical properties and enhanced therapeutic potential.
  • The QbD approach successfully identified critical variables and established optimal manufacturing conditions for a stable and effective drug product.
  • This 'green' nanocrystal technology presents a significant advancement for pharmaceutical research and development, enabling the creation of improved drug delivery systems.