Issue link: https://www.e-digitaleditions.com/i/1073928
Inhalation February 2019 13 7. Japanese Pharmacopoeia XVII, Supplement I. 2018. 6.14 Uniformity of delivered dose for inhalations. 8. Vincenzi, C., 2017. Update on the guideline on the pharmaceutical quality of inhalation and nasal products. Drug Delivery to the Lungs 2017. 9. European Medicines A genc y Committee for Medicinal Products for Human Use (CHMP). Guide- line on the requirement for clinical documentation for orally inhaled products. 2009. CPMP/EWP/4151/00 Rev. 1. Available at: http://www.ema.europa.eu/docs/ e n _ GB/d o c u m e nt _ l i br a r y/S c i e nt i f i c _ g u i d e line/2009/09/WC500003504.pdf. 10. FDA Draft guidance on f luticasone propionate; salmeterol xinofoate. 2013. Available at: http://www. fda.gov/downloads/drugs/guida ncecomplia nce regulatoryinformation/guidances/ucm367643.pdf. 11. Therapeutic Goods Administration ADoHaA: Australian Public Assessment Report for glycopyrro- nium (as bromide). 2013. Available at: https://www. tga.gov.au/sites/default/f iles/auspar-glycopyrro nium-130710.pdf. 12. EDQM Standard Terms Database. http://stan dardterms.edqm.eu. Reproduced with the permis- sion of the European Directorate for the Quality of Med icine s & Hea lt hCa re, C ou nci l of Eu rope (EDQM). Retrieved on September 5, 2018. The EDQM Standard Terms database is not a static list and content can change over time. 13. United States Pharmacopoeia 41. 2018. Inhala- tion and nasal drug products—general information and product quality tests <5>. A ll trademarks referenced within this article are owned by the respective third parties. Jagdeep Shur, PhD is a Research Fellow and Robert Price, PhD is a Professor at the University of Bath, www. bath.ac.uk. Tim Rouse, BSc is a Senior Scientist and David Lewis, PhD is Director of Aerosol Research at Chiesi, Ltd., www.chiesi.com. Dilraj Singh, PhD is a Director of Global Regulatory Affairs CMC, Bradley Morrical, PhD is an Analytical Network Leader and Stephen Edge, PhD is an Analytical Expert at Novartis Pharma AG, www.novartis.com. Corresponding author: David Lewis, PhD, Chiesi, Ltd., Units T1 - T3, Bath Road Industrial Estate, Chippenham, Wiltshire, SN14 0AB, Tel.: +44 1249 466930, d.lewis@chiesi.com. questioned when a similar parameter is available from the APSD test. Although the use of delivered dose serves as a nominal amount of drug delivered to the patient when labeling DPIs, careful consider- ation should be given to the fact that this dose expression is not representative of the amount of drug deposition in the lungs and to the analytical methodologies a nd practica lities of such tests. Labeling the dose of DPIs relative to an APSD met- ric, as included as a labeling option within the EMA quality guideline, would provide a more clinically relevant definition of dosage strength. It appears that regulators do not typically require that such APSD metrics are included in any publi- cally available product information and industry does not seem to proactively disclose this. Indeed, even though some APSD stage grouping limits for some products are available in the USP, the general lack of publically available originator DPI APSD specifications is a major challenge for the develop- ment of generic DPIs. If any such APSD metrics were required to be included in any label claim/ labeling, then this would need the consensus of the various regional regulatory bodies such as the FDA, EMA, etc. and industry groups such as the Interna- tional Pharmaceutical Aerosol Consortium on Reg- ulation and Science (IPAC-RS), the European Phar- maceutical Aerosol Group (EPAG) and others. Until that time, it appears that the delivered dose will continue to be an important metric for the label claim/labeling of DPIs and, as such, a full under- standing of this metric is required. References 1. European Medicines A genc y Committee for Medicina l Products for Huma n Use (CHMP). Guideline on the pharmaceutical quality of inhala- t i o n a n d n a s a l p r o d u c t s . E M E A / C H M P/ QW P/49313/2005 Corr. 2006. Issued June 21, 2006. Available at: http://w w w.ema.europa.eu/ docs/en_GB/document_library/Scientific_guide line/2009/09/WC500003568.pdf. 2. United States Pharmacopoeia 41. 2018. Inhala- tion and nasal drug products: aerosols, sprays, and powders—performance quality tests <601>. 3. Chinese Pharmacopoeia (English version). 2015. 0111 Preparations for inhalation. 4. United States Pharmacopoeia 41. 2018. Labeling <7>. 5. FDA Center for Drug Evaluation and Research (CDER). Metered dose inhaler (MDI) and dry pow- der inhaler (DPI) products - quality considerations guidance for industry (draft). Revision 1. Issued April 2018. Available at: https://www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInforma tion/Guidances/UCM070573.pdf. 6. European Pharmacopoeia 9.5. 2018. Preparations for inhalation 0671 Inhalanda.