The United States (US) Food and Drug Administration (FDA) have revised draft guidance on the development and manufacture of inhalation aerosols (also known as metered dose inhalers (MDIs)) and inhalation powders (also known as dry powder inhalers (DPIs)). The guidance describes points to consider in order to ensure product quality and performance for MDIs and DPIs. It states chemistry, manufacturing, and controls (CMC) information recommended for inclusion in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The principles are also applicable to products used during clinical trials, and over the product lifecycle.
The 46-page draft guidance, originally published in 1998, has been updated to echo current standards and requirements to enhance industry’s understanding of the development approaches for these products, consistent with the FDA’s quality by design paradigm.
The recommendations in the draft guidance apply to MDI and DPI products that are intended for local or systemic effect. The guidance does not discuss aqueous-based nasal spray drug products and inhalation solution, suspension, and spray drugs products, or the manufacture of drug substances. However, although not explicitly discussed, the FDA states that some of the principles and recommendations provided in the draft may apply to nasal delivery products.
The draft guidance contains information on certain aspects of labelling for NDA and ANDA MDI and DPI products. Sections of the draft feature discussions on critical quality attributes to be developed for the combination products, product and process development steps, the development of a control strategy and what specific information should be submitted in a company’s application.
To read the draft guidance from the FDA on ‘MDI and DPI products – quality considerations’, please click here.