Metered Dose and Dry Powder Inhalers: FDA Revises Draft Guidance
The US Food and Drug Administration (FDA) on Wednesday published a revised draft guidance on metered dose inhalers (MDIs) and dry powder inhalers (DPIs), offering recommendations on chemistry, manufacturing, and controls (CMC) information to be included in new drug applications (NDAs) and abbreviated new drug applications (ANDAs).Both MDI and DPI products, such as GlaxoSmithKline’s Advair (fluticasone/salmeterol) or AstraZeneca’s Symbicort (budesonide/formoterol) are used to treat lung diseases, including asthma and chronic obstructive pulmonary disease (COPD), in addition to respiratory infections and cystic fibrosis.
The 50-page draft, originally published in 1998, has been updated to reflect current standards and requirements to enhance industry’s understanding of the development approaches for these products, consistent with FDA’s quality by design paradigm.
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.
Although not explicitly discussed, FDA said some of the principles and recommendations provided in this draft may be applicable to nasal delivery products. The recommendations also can apply to MDI and DPI products intended for local or systemic effect, but the guidance said it does not discuss aqueous-based nasal spray drug products and inhalation solution, suspension, and spray drug products, or the manufacture of drug substances.
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations: Draft Guidance for Industry