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Spray-dry manufacturing is amenable to a variety of compound chemistries and may be useful in development of inhalation products that pursue the US FDA’s 505(b)(2) submission pathway. 22 December 2018 Inhalation Respirable, engineered, spray-dried dry powders for 505(b)(2) drug product development Spray-dry manufacturing is amenable to a variety of compound chemistries and may be a useful tool for the development of inhalation drug products that pursue the US FDA's 505(b)(2) submission pathway. Jeffrey Breit, PhD a and Aditya R. Das, PhD, MBA b a CADA Consulting, LLC b Recipharm Laboratories, Inc. The 505(b)(2) application e 505(b)(2) New Drug Application (NDA) is one of the United States Food and Drug Administration (FDA) drug approval pathways and may represent an appealing regulatory strategy for groups seeking to use a precedented compound in a new inhalation delivery modality. e 505(b)(2) pathway was created by the Hatch-Waxman Amendments of 1984 and the term "505(b)(2)" refers to a section of the United States Federal Food, Drug and Cosmetic Act. e provisions of 505(b)(2) were created, in part, to help avoid unnecessary duplication of studies already performed on a previously approved ("reference" or "listed") drug and give the FDA express permission to rely on data not developed by the NDA applicant. New products based on the 505(b)(2) approval pathway often con- tain well-understood active pharmaceutical ingredi- ents (APIs) that are present in existing, approved drug products (reference drugs). Therefore, companies must only create a bridge between what is already known about the previously approved reference drug and the novel drug product or indication. 1, 2 505(b)(2) NDA applications include complete safety and effectiveness reports but allow at least some of the required information (for instance, data on safety and efficacy of an API) to be sourced from studies not con- ducted by or for the 505(b)(2) applicant. 3 Compared with a traditional development path for an originator product (such as the FDA's 505(b)(1) route), the reduced data burden of the 505(b)(2) pathway may result in a much less expensive and faster route to approval, while enabling and creating new, differenti- ated products with significant patient and commercial value. In Europe, a regulatory approval route similar to the 505(b)(2) pathway is the hybrid procedure based on Article 10 of Directive 2001/83/EC. Caution: is article is being published only for pur- poses of general education, not as a definitive guide for product development. Regulations within the United States and around the world vary and are continually evolving. erefore, we strongly caution you to work closely with representatives of the regulatory agencies, as well as in-house regulatory personnel and/or independent consul- tants, to determine requirements for your particular prod- uct and the best approach in seeking regulatory approval. Spray-dry technology can create powders for early- stage formulation screening and characterization, prior to large-scale manufacturing. Some spray dryers, such as the Buchi B-290 spray dryer, are relatively API-sparing and can be used with aqueous or organic solvents to screen APIs with varying physical properties. (Photo courtesy of Buchi AG.)