Dry Powder Inhalers (DPI) Managing the Unique Requirements in DPI Manufacturing

Related Vendors

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

Donadon SDD Srl

Dry Powder Inhalers (DPIs) are among the most sophisticated drug-device combination products in pharmaceutical manufacturing. Their performance depends on the interaction between powder formulation, micro-dosing accuracy, and the assembly of complex components. Each step requires tight process control to ensure dose consistency, patient safety, and regulatory compliance.

Within the pharmaceutical industry, Dry Powder Inhalers (DPIs) represent a critical and complex drug delivery system, especially for respiratory therapies. Their safety, efficacy, and consistency depend on highly controlled processing, accurate micro-dosing, and robust assembly solutions that meet regulatory and quality requirements. Powders used in DPI formulations are often highly potent and administered in very low doses, making containment, repeatability, and real-time process control essential throughout manufacturing. The assembly of inhalers must be flexible, scalable, and capable of integrating multiple components, from powder mixing, dosing, and capping to welding and packaging.

Active Ingredients and Powder Processing

The manufacturing of DPIs begins with the blending of a fine Active Pharmaceutical Ingredient (API) with larger carrier particles to achieve a homogeneous and deagglomerable powder formulation. The objective of this process is to ensure sufficient adhesion of API particles to the carrier, allowing detachment during inhalation for efficient pulmonary drug delivery. This process needs precise control of variables such as mixing energy, duration, speed, and the sequence of ingredient addition. Insufficient control may result in poor dose uniformity, inadequate aerosolisation, or excessive agglomeration, all of which can compromise product performance.