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Defining the mass fraction penetrating thenasopharynx16• 1st STEP:• Define standardizedentry port:• Doub and Adams (2002 – AAPSAnnual Meeting) exploredvarious sizes of inverted roundbottomed flasks for use testingnasal spray pumps• Linked with abbreviated cascadeimpactor to determine massfraction
Define standard entry port17• Doub and Adams (2002):• 1 L flask was too small• Larger (2 L and 5 L flasks)required a pre-separator• • Observations-1:• Choice of a fixed flow rate waslimiting:• Adult: 10-40 L/min• Häußermann et al. J.Aerosol Sci.(2002);33:929-933.• Adult: 7 – 50 L/min• Child: 5 – 20 L/min• Cheng AS&T. (2003); 37:659-671Observations-2:• Even a 2 L flask is much largerthan the ca. 15 mL volume of thenasal cavitycourtesy J.D. Suman, Nextbreath LLC
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: What current in-vitro methods can a
Page 19 and 20: Nasal induction port design19Work i
Page 21 and 22: Size, characterizing the entire dos
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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