Generic Symbicort®: Navigating the Technical and Regulatory Hurdles for Budesonide/Formoterol Fumarate Pressurized Metered Dose Inhaler
Stein SW, Kriesel K, Drake J, Purrington AM, Ledoux KA, Walls SM, Stone CK, Schultz DW, Miller J, Fritz R, Sessions V, Jackson E, Parkinson A, Fletcher I, Pannu RK, Berry M, Cook W, Ng D, Ward J.
Respiratory Drug Delivery 2024. Volume 1, 2024: 145-153.
Abstract:
To successfully develop an orally inhaled drug product, there are numerous challenges that must be overcome. There are technical challenges associated with identifying a stable product configuration capable of meeting stringent regulatory requirements and identifying a suitable manufacturing process, achieving regulatory approval, managing complex supply chains, and ensuring that commercial manufacturing capacity is in place. The approval of generic inhalers may require overcoming additional challenges, such as demonstrating bioequivalence through in vitro bioequivalence (IVBE), pharmacokinetic (PK) and clinical endpoint studies. Currently approved generic pressurized metered dose inhalers (pMDIs) on the US market consist of authorized generics, generic albuterol pMDIs and Breyna™. This article describes challenges overcome during Breyna development.
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