Inhalation

INH0218

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The Inhalation and Nasal Technology Focus Group is supporting conference programs, webinars, student participation and development of an inhalation biopharmaceutical classification system. The Inhalation and Nasal Technology Focus Group: Evolving to meet the needs of its scientific community Members of the INTFG inhalation product science and de- velopment. For example, a webi- nar titled "Metered Dose Inhalers 101" to be presented by Dr. Mark Sommerville is scheduled for Janu- ary 18, 2018. is webinar is in- tended to introduce formulation scientists, device engineers and other pharmaceutical professionals to the technical considerations needed for metered dose inhaler (MDI) development. Content will include the basics of formulation science for MDI solutions and sus- pensions, device design for MDI componentry (valve, can and actu- ator), and the ways these factors combine to influence the inhala- tion product performance. In- sights will also be provided on re- cent advances in MDI formulation and device technologies and the needs these new technologies are meeting. Additional webinars in the series include "Clinically rele- vant in vitro tests for the assess- ment of nasally administered drug products," "INTFG Back to Ba- sics—Nebulization" and others topics. Watch the INTFG discus- sion board on the AAPS website for dates. Developing a classification system for inhaled drugs Over the past four years, the INT- FG has been working on a bio- pharmaceutical classification sys- tem (BCS) for inhalation drugs. As with the immediate release oral drug product BCS (the "giBCS"), a pulmonary or inhalation "iBCS" concept would guide a discovery chemist in selection of new chem- ical entities intended for pulmo- e American Association of Pharmaceutical Sciences (AAPS) Inhalation and Nasal Technology Focus Group (INTFG) has sup- ported a number of activities this past year and several upcoming events are planned. A presentation on MDI propellants At the 2017 Respiratory Drug De- livery (RDD) Europe Annual meeting in France, the INTFG supported a scientific presentation by Dr. Tim Noakes and Stuart Corr from Mexichem UK, Ltd. e talk was titled "e Future of Metered Dose Inhalers and eir Propel- lants, Status Quo or Time for a Change?" e presentation was part of a continued presence that the INTFG has at each RDD, with an open meeting followed by a sci- entific presentation. e objectives are to engage as many members as possible who attend RDD and to open the group to exposure from non-INTFG members. Supporting programming on genome editing At the 2017 AAPS Annual Meet- ing, the focus group supported programming around the rapidly emerging and important topic of "Challenges and Opportunities for Gene Editing and Delivery" and recruited several speakers in- cluding Professor Cory Berkland from the University of Kansas, Dr. Hao Yin from MIT and Pro- fessor Gene Yeo from UCSD. ere is significant interest in de- veloping gene editing and inhala- tion delivery for the treatment of genetic diseases that manifest in the airways, such as cystic fibrosis. In recent years, several new ge- nome-editing technologies have been developed. Of these, the zinc finger nucleases (ZFNs), tran- scription activator-like effector nucleases (TALENs) and the CRISPR/Cas9 RNA-guided en- donuclease system are the most widely described. Each of these technologies utilizes restriction enzymes to introduce a DNA double-stranded break at a target- ed location with the guidance of homologous binding proteins or RNA. Such targeting is viewed as a significant advancement com- pared to current gene therapy methods that lack such specificity. Proof-of-concept studies have been performed to treat multiple disorders, including in vivo exper- iments in mammals and even ear- ly phase human trials. Careful consideration and investigation of delivery strategies will be required so that the therapeutic potential for gene editing is achieved. In this session, the mechanisms of these gene editing technologies and evidence of therapeutic po- tential was introduced. e major focus of the session was the phar- maceutical development ap- proaches and the biological delivery obstacles. Back to basics webinars A major effort of the INTFG has been the development and sched- uling of a "Back to Basics" webinar series focused on inhalation aero- sols. is webinar series covers the fundamentals of several aspects of 4 February 2018 Inhalation organizations Cross-industry

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