In the other FDA talk in this session, Ross Walenga offered recommendations for the use of in silico testing in establishing BE, which he notes is described in detail in a recent PSG for formoterol fumarate / glycopyrrolate MDIs. Walenga said that although such modeling is optional, he would try to convince delegates of “the utility of these in silico studies and how they can be useful for generic drug product development.”
While the speakers in the “Inhalation Innovation” session mainly discussed inhaled drug products, in vitro and in vivo approaches to establishing BE for nasal products also received attention in the poster presentation and in the workshop session, where Intertek specifically addressed the use of in-vitro only BE approaches for nasal suspension products in its workshop. In addition, a group representing the IPAC-RS presented a poster highlighting results of a survey that it conducted on the use of laser diffraction size analysis for nasal drug product testing, concluding that, “The response to this survey is consistent with its recognition by the regulatory authorities as a requisite for the in vitro evaluation of these products.”
Addressing a different trend in regulatory issues related to generic drug development, attorney Kurt Karst provided an overview of issues related to the listing of device patents in the Orange Book, which has recently been the subject of investigations and actions by the US Federal Trade Commission (FTC) and Congress alleging that pharma companies are trying to prevent generic competition. In response to a question, Karst explained that the FDA’s “Purple Book,” which lists biologics, does not include patents, and litigation over biologics would not delay approval.
The transition to LGWP propellants
Three of the four main conference sponsors — Bespak, Kindeva Drug Delivery, and Honeywell — presented workshops on the transition to LGWP propellants, while HFA 152a maker Koura maintained a lower profile at RDD 2024. Bespak, which recently spun off from Recipharm to focus on the LWGP transition, partnered with Honeywell to present a workshop on the use of Honeywell’s HFO 1234ze(E) and presented research on both new propellants in the poster exhibition.
