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Inhaled Medications01:23

Inhaled Medications

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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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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Site-Targeted Drug Delivery Systems: Polymeric Carriers01:24

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Polymeric carriers enhance targeted drug delivery by increasing efficacy while minimizing off-target effects. These carriers comprise a biodegradable polymeric backbone integrated with functional elements that enable targeting, improve physicochemical properties, and regulate drug release.Targeting MechanismsThe targeting ability of polymeric carriers is mediated by a homing device, which is a molecular recognition component designed to selectively bind to specific tissues or cells. Monoclonal...
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Drug Delivery: Miscellaneous Routes01:22

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Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection,  and rectal administration provide localized effects with reduced toxicity.
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Modified-Release Drug Delivery Systems: Rate-Programmed I01:22

Modified-Release Drug Delivery Systems: Rate-Programmed I

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Rate-programmed drug delivery systems (DDS) are designed to release drugs at specific, controlled rates to maintain consistent therapeutic levels. These systems are categorized based on their release mechanisms, including dissolution-controlled DDS, diffusion-controlled DDS, and combined dissolution-diffusion-controlled DDS.In dissolution-controlled DDS, the release rate depends on the slow dissolution of the drug itself or the surrounding matrix. Drugs with inherently slow dissolution rates,...
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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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Advancing Dry Powder Inhalers: A Complete Workflow for Carrier-Based Formulation Development.

Rodrigo Amorim1, Navneet Sharma1, Molly Gallagher1

  • 1Product Development, Lonza Advanced Synthesis, Lonza Group AG, Bend, OR 97701, USA.

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|February 27, 2026
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Summary
This summary is machine-generated.

This study presents a Quality-by-Design (QbD) framework for dry powder inhaler (DPI) development, optimizing particle engineering and blending for robust respiratory drug delivery. The integrated approach ensures scalable manufacturing from API characterization to commercial production.

Keywords:
carrier-based formulationdry powder inhalerhigh shear mixingjet millinglow shear mixingpharmaceutical manufacturingquality by design (QbD)scale-up

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Process Engineering

Background:

  • Carrier-based dry powder inhalers (DPIs) are standard for respiratory drug delivery.
  • Integrated frameworks for particle engineering and manufacturing scale-up are lacking for DPIs.

Purpose of the Study:

  • To develop a comprehensive Quality-by-Design (QbD) strategy for carrier-based DPIs.
  • To systematically link jet milling, formulation, and blending scale-up for micronized active pharmaceutical ingredients (APIs).

Main Methods:

  • Phenytoin API was micronized using jet milling to control particle size and solid-state properties.
  • Design of Experiments (DoE) assessed API particle size and lactose fines on aerodynamic performance (FPF) and powder flow.
  • A particle-velocity-based scale-up method was developed for V-shell blending.

Main Results:

  • Optimized jet milling yielded inhalation-grade API particles with controlled amorphous content.
  • A design space was identified maximizing aerosolization and flowability (API Dv90: 2.9-4.5 µm).
  • Low-shear blending and particle-velocity scale-up ensured superior, scalable lung delivery (FPF >60%) and content uniformity.

Conclusions:

  • An integrated QbD framework is crucial for robust and scalable DPI product development.
  • Co-optimization of particle engineering, formulation, and blending dynamics is essential.
  • This approach provides an efficient, material-sparing pathway for DPI manufacturing.