Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products–Quality Considerations

Issue Date: April 19, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Draft

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products–Quality Considerations

The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (or MDIs)) and inhalation powders (also known as dry powder inhalers (or DPIs)). The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.

Download the Guidance Document

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