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Inhalable Ipratropium Bromide Particle Engineering with Multicriteria Optimization.

Bhavani Prasad Vinjamuri1,2, Rahul V Haware1, William C Stagner3

  • 1College of Pharmacy & Health Sciences, Department of Pharmaceutical Sciences, Campbell University, Buies Creek, North Carolina, USA.

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Summary
This summary is machine-generated.

Spray-dried ipratropium bromide (IPB) microspheres were developed using Quality by Design principles. This study established a design space for inhalable microparticles, enabling the rational development of a commercial dry powder inhaler.

Keywords:
design of experimentsdry powder inhaleripratropium bromidemulticriteria optimizationquality by designspray drying

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Process Engineering

Background:

  • Ipratropium bromide (IPB) is a crucial medication for respiratory diseases.
  • Developing effective dry powder inhalers (DPIs) requires precise control over microparticle properties.
  • Quality by Design (QbD) offers a systematic approach to product development.

Purpose of the Study:

  • To engineer spray-dried ipratropium bromide (IPB) microspheres for oral inhalation using QbD.
  • To establish a robust operating design space for inhalable microparticle production.
  • To enable the rational design of a commercial IPB dry powder inhaler.

Main Methods:

  • Utilized a 2^7-3 screening design to identify critical process parameters and material interactions.
  • Employed a response surface custom design for optimization and determination of the design space.
  • Developed statistically significant predictive models for key quality attributes like particle size, span, yield, and outlet temperature.
  • Confirmed model predictive capability through an independent verification batch.

Main Results:

  • Identified the Maillard reaction between L-leucine and lactose at outlet temperatures >130°C.
  • Developed predictive models with high statistical significance (adjusted R² > 0.79 for all).
  • Achieved inhalable microparticles with a volume median diameter of 3.32 ± 0.09 μm and span of 1.71 ± 0.18.
  • Observed a process yield of 50.3% and an outlet temperature of 100°C in the verification batch.
  • Confirmed label strength of IPB microparticles within 99.0-105.9% w/w, indicating enrichment during spray-drying.

Conclusions:

  • The QbD approach successfully enabled rational design of IPB microspheres.
  • The established design space supports the production of inhalable microparticles.
  • The findings provide a foundation for the development of the first commercial IPB dry powder inhaler.