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Defining the mass fraction penetrating thenasopharynx202nd Step: Establish a size-selective cutpointclose to 10 μm aerodynamicdiameter:• Requires inertial classifier following inlet• Impactor pre-separator almost certainlyneeded if a low volume induction portis used• 3rd Step: Optimize choice of inertialimpactor:• A conventional 7 or 8 stage full resolutionsystem could be used• However, abbreviated 1 or 2 stageimpactors are becoming available:• Greatly simplify the measurementprocess• More rapid measurement possible –better coverage/decision making forbatch disposition in QC
Size, characterizing the entire dose21• Inertial impaction methods areineffective for droplets > 20 μmaerodynamic diameter• Mass median droplet sizesfor nasal spray pumps aretypically in the 40-80 μmrange• Laser Diffractometry (LD)has become the industrystandard• Recommended techniquefor nasal sprays and nasalaerosols in the FDA BA/BEDraft GuidanceMalvern SpraytecLD with nasal spraypump and automatedactuatorCourtesy Malvern Instruments
Page 1 and 2: 1EPAG Perspective - RegulatoryAdvan
Page 3 and 4: EPAG, what is it?, background, this
Page 5 and 6: EPAG, what is it?, background, this
Page 7 and 8: REGULATORY: Heath Canada-EMEA7• H
Page 9 and 10: REGULATORY: Heath Canada-EMEA9Pharm
Page 11 and 12: CMC documentation: Nasal sprays11De
Page 13 and 14: Draft Nasal BA/BE guidance …13Sin
Page 15 and 16: What current in-vitro methods can a
Page 17 and 18: Define standard entry port17• Dou
Page 19: Nasal induction port design19Work i
Page 23 and 24: Time averaged v-PSD23• Capable of
Page 25 and 26: Raman chemical imaging25• Raman s
Page 27 and 28: Challenges….27• Identify suitab
Page 29 and 30: Results to date….29Inverted NGI&
Page 31: Acknowledgments and thanks to ….3

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