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6. Wilcox D, Lacombe J, Brown J, Richardson M, Davies-Cutting C. Case study: Does spray pattern test- ing provide a discriminating measure of metered dose inhaler (MDI) product performance? In: RN Dalby, PR Byron, J Peart, JD Suman, SJ Farr, PM Young, (edi- tors): Respiratory Drug Delivery 2010. Davis Health- care International, River Grove, IL, US; pp 485-488. 7. Guo C, Doub WH. The influence of actuation parameters on in vitro testing of nasal spray products. September 2006, Journal of Pharmaceutical Sciences, Vol. 95, p. 2029-2040. Lingzhi Liao, MS is a Field Applications Scientist, Heli Chauhan, MS is a Senior Application Chemist, Alyssa Newcomb, BS is an Associate Product Manager, Tim L'Ecuyer, BS is a Senior Product Engineer, Shau Neen Liu- Cordero, PhD is a Senior Product Manager and Chip Leveille, BS is the Chief Commercial Officer at Proveris Scientific Corporation. Corresponding author: Heli Chauhan, Proveris Scientific Corporation, 290 Donald Lynch Boulevard, Suite 100, Marlborough, MA, 01752, US, Tel.: +1 508 460-8822, hchauhan@proveris.com, www.proveris.com. development. is type of analysis can be applied to other aspects of product development not examined in this study, such as valve, canister and mouthpiece design or formulation components, as well as to other types of devices including nasal spray products. 7 Addi- tional studies will be necessary to look at the relation- ship of spray pattern to other measures, such as deposi- tion and particle size, as suggested by Smyth, et al. 4 References 1. Farina DJ. Regulatory aspects of nasal and pulmo- nary spray drug products. [Book Author] Kulkarni VS, Andrew W. Handbook of Noninvasive Drug Delivery Systems. Norwich: s.n., 2009, pp. 247-287. 2. Draft CMC Guidelines on Metered Dose Inhaler and Dry Powder Inhaler Drug Products. fda.gov. [Online] October 1998. https://www.fda.gov/ downloads/Drugs/.../Guidances/ucm070573.pdf. 3. Hammond B. Generic pMDI product development for the US: Key considerations. 2014, ONdrugDeliv- ery, 50, pp. 29-31. 4. Smyth H, Brace G, Barbour T, Gallion J, Hickey AJ. Spray pattern analysis for metered dose inhalers: Effect of actuator design. July 2006, Pharmaceutical Research, Vol. 23, No. 7. p. 1591-1596. 5. Draft Guidance for Industry: Bioavailaility and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action. fda.gov. [Online] April 2003. h t t p s : / / w w w. f d a . g o v / d o w n l o a d s / D r u g s / GuidanceComplianceRegulator yInformation/ Guidances/UCM070111.pdf. Figure 9 Examples of spray pattern image and intensity vs. time graphs for Ventolin in sump #2 (top) and sump #3 (bottom). 26 OctOber 2017 Inhalation