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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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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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Choosing the appropriate route of drug administration is significantly influenced by two key factors: the therapeutic objectives and the inherent properties of the drug being used.
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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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Chronic obstructive pulmonary isease (COPD) involves a group of progressive lung disorders characterized by persistent airflow limitation and chronic respiratory symptoms. Asthma-COPD Overlap Syndrome (ACOS), encompassing features of both asthma and Chronic obstructive pulmonary disease (COPD), is a group of progressive lung disorders that includes chronic bronchitis, emphysema, and refractory (non-reversible) asthma. ACOS leads to complex clinical presentations that combine the inflammatory...
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Updated: May 20, 2025

Disposable Dosators for Pulmonary Insufflation of Therapeutic Agents to Small Animals
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Navigating the Development of Dry Powder for Inhalation: A CDMO Perspective.

Beatriz Noriega-Fernandes1, Mariam Ibrahim1, Rui Cruz1

  • 1Small Molecules Product Development, Lonza Group AG, Bend, OR 97701, USA.

Pharmaceuticals (Basel, Switzerland)
|March 27, 2025
PubMed
Summary
This summary is machine-generated.

This paper offers a CDMO-centric roadmap for developing inhaled dry powder drug products. It guides newcomers through formulation, particle engineering, and encapsulation for successful pulmonary/nasal delivery.

Keywords:
CDMOcapsule fillingdry powder inhalersjet millingpre-clinical studiesrespiratory deliveryspray drying

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery
  • Biotechnology

Background:

  • Growing interest in pulmonary/nasal drug delivery for challenging molecules (poor solubility, biologics) and new stakeholders entering the field.
  • Contract Development and Manufacturing Organizations (CDMOs) are crucial for inhalation product development but lack a clear, integrated roadmap.
  • Existing literature does not provide a unified framework for inhaled drug product development from a CDMO perspective.

Purpose of the Study:

  • To provide a CDMO-centric, stepwise roadmap for developing inhaled dry powder drug products.
  • To highlight key aspects of product development, offering practical guidance for newcomers.
  • To bridge preclinical, formulation, manufacturing, and encapsulation considerations.

Main Methods:

  • Development of a novel, stepwise strategy for inhalable drug product development.
  • Analysis of critical aspects including target product profile definition and preclinical dose selection.
  • Evaluation of API characteristics (small molecule vs. biologic) and formulation choices (dry powder focus).

Main Results:

  • Guidance on selecting particle engineering technologies (jet milling, spray drying) with pros and cons.
  • Discussion of challenges and considerations for encapsulating spray-dried and jet-milled powders.
  • Presentation of a unified framework integrating preclinical, formulation, manufacturing, and encapsulation.

Conclusions:

  • The proposed roadmap facilitates decision-making for inhaled dry powder product development.
  • This publication serves as a practical tool for CDMOs and new entrants in the field.
  • Offers a comprehensive approach to navigate the complexities of pulmonary/nasal drug product development.