The FDA’s Draft Guidance for Industry, “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations” released in April 2018, discusses quality attributes for metered dose inhalers (MDIs) and dry powder inhalers (DPIs). Regardless whether pursuing innovator or generic product development, the importance of establishing a desired quality target product profile (QTPP) is highlighted, in order to define the characteristics of the drug product that ideally will be achieved to ensure the desired quality. Further, it is recommended that the applicant, from the earliest stages of development, develop a list of critical quality attributes (CQAs) to ensure such desired product quality. Characterization methods play an important role in helping ensure a robust process for quality control and assisting in gaining regulatory approval.
How critical quality attributes of the drug substance can support orally inhaled and nasal drug product (OINDP) quality
This article presents case studies and highlights ways key physical properties of drug substance particles might be adjusted and measured to meet a quality target product profile (QTPP). Morphic form, particle shape and surface characterization were studied and a variety of analytical techniques were used. Characterization results for fluticasone propionate, fluticasone furoate, vilanterol trifenatate and/or salmeterol xinafoate powders, micronized by jet milling and/or wet polishing, and various process parameters for the techniques, are discussed.