Navigating the Development of Dry Powder for Inhalation: A CDMO Perspective

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.