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Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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In precipitation gravimetry, the precipitating agent should react specifically or selectively with the analyte. While a specific reagent reacts with the analyte alone, a selective reagent can react with a limited number of chemical species.
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The one-compartment model is a pharmacokinetic tool that models the body as a single, uniform compartment, facilitating the understanding of drug distribution and elimination. This model is particularly beneficial for intravenous (IV) bolus administration, where the drug rapidly circulates throughout the body.
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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Related Experiment Video

Updated: Jul 15, 2025

Disposable Dosators for Pulmonary Insufflation of Therapeutic Agents to Small Animals
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Emerging Process Modeling Capabilities for Dry Powder Operations for Inhaled Formulations.

Hao Lou1, Li Ding1, Tian Wu1

  • 1Drug Product Technologies, Process Development, Amgen, One Amgen Center Drive, Thousand Oaks, California 91320, United States.

Molecular Pharmaceutics
|October 2, 2023
PubMed
Summary
This summary is machine-generated.

Manufacturing dry powder inhalers (DPIs) involves critical steps like milling, blending, and filling. Process modeling, particularly discrete element method (DEM) simulation, is key for optimizing DPI development and performance.

Keywords:
Dry powder inhalationDry powder manufacturingMechanistic modelingQuality by Design (QbD)Simulation

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Area of Science:

  • Pharmaceutical Manufacturing
  • Powder Technology
  • Computational Modeling

Background:

  • Dry powder inhaler (DPI) products are typically formulated as micronized drug particles mixed with larger carrier particles.
  • DPI manufacturing involves critical unit operations: particle size reduction, blending, and powder filling into various dose containment systems.

Purpose of the Study:

  • To review critical process parameters (CPPs) in DPI manufacturing unit operations.
  • To highlight the application of empirical and mechanistic models, especially discrete element method (DEM) simulations, in DPI process development.

Main Methods:

  • Review of critical process parameters for jet milling, high-shear blending, and capsule filling.
  • Analysis of recent advancements in modeling and simulation for DPI process development.

Main Results:

  • Identification of key process parameters influencing DPI manufacturing.
  • Demonstration of the growing role of modeling and simulation, particularly DEM, in understanding and optimizing DPI processes.

Conclusions:

  • DPI process design and development are increasingly driven by modeling and simulation.
  • Advancements in computational power will enable more accurate and complex simulations for real-world DPI operations, improving process performance evaluation.