cal polymer nanoparticles. 2004; International Journal of
Pharmaceutics. 284:13-21.
12. Patton JS: Mechanisms of macromolecular absorption by
the lungs. 1996; Advanced Drug Delivery Reviews. 19:3-36.
13. Berardis D, Fornaro M, Orsolini L, Iasevoli F, Tomasetti
C, Bartolomeis A, Sevaroni N, Valchera A, Carano A, Vel-
lante F, Marini S, Piersanti M, Perna G, Martinotti G,
Giannantonio M: e role of inhaled loxapine in the treat-
ment of acute agitation in patients with psychiatric disor-
ders: A clinical review. 2017; International Journal of
Molecular Sciences. 18:349-364.
14. Elversson JE, Millqvist-Fureby A: Particle size and density
in spray drying-effects of carbohydrate properties. 2005; Jour-
nal of Pharmaceutical Sciences. 94:2049-2060.
15. Fäldt P, Bergenståhl B: e surface composition of spray-
dried protein—lactose powders. 1994; Colloids and Surfaces
A: Physicochemical and Engineering Aspects. 90:183-190.
16. Duddu SP, Sisk SA, Walter YH, Tarara TE, Trimble KR,
Clark AR, Eldon MA, Elton RC, Pickford M, Hirst PH, New-
man SP, Weers JG: Improved lung delivery from a passive dry
powder inhaler using an engineered Pulmo-Sphere powder.
2002; Pharmaceutical Research. 19:689-695.
17. Weers JG, Bell J, Chan H-K, Cipolla D, Dunbar C,
Hickey AJ, Smith IJ: Pulmonary formulations: What remains
to be done? 2010; Journal of Aerosol Medicine and Pulmo-
nary Drug Delivery. Suppl 2:S5-S23.
18. DPI-tobra-kind Cyclops
®
in children with cystic fibrosis.
Onno Akkerman, University Medical Center Groningen.
August 3, 2018. NIH US National Library of Medicine.
https://clinicaltrials.gov/ct2/show/NCT03485456?term=
inhalation%2C+dr y+powder&recrs=abdf&rank=2.
Accessed September 2018.
19. Summative usability study of ciprofloxacin dry powder for
inhalation using placebo. Bayer. April 7, 2016. NIH US
National Library of Medicine. https://clinicaltrials.gov/ct2/
show/NCT02661438?term=inhalation%2C+dry+pow
der&rank=6. Accessed September 2018.
20. Bevespi Aerosphere™ approved by the US FDA for
patients with COPD. AstraZeneca. April 26, 2016. https://
www.astrazeneca.com/media-centre/press-releases/2016/
bevespi-aerosphere-approved-by-the-us-fda-for-patients-
with-copd-25042016.html). Accessed September 2018.
21. Newhouse MT, Hirst PH, Duddu SP, Walter YH, Tarara
TE, Clark AR, and Weers JG: Inhalation of a dry powder
tobramycin Pulmosphere formulation in healthy volunteers.
2003; Chest. 124:360-366.
22. Borgström L, Olsson B, and orsson L: Degree of throat
deposition can explain the variability in lung deposition of
inhaled drugs. 2006; Journal of Aerosol Medicine. 19:473-
483.
Jeffrey Breit, PhD, is Principal/Owner of CADA Con-
sulting, LLC, jeffbreit@cadaconsulting.net. Aditya R.
Das, PhD, MBA is Director, Business Development,
Recipharm Laboratories, Inc., aditya.das@recipharm.
com, www.recipharm.com.
As the FDA approval guidelines dictate the use of exist-
ing and new supporting data for product approval, it is
imperative that any lead technology be accessible,
robust and familiar to vendors and consultants in order
to streamline and reduce development costs. ese val-
ue-added aspects of spray drying lend themselves to
rapidly addressing many of the needs of a 505(b)(2)
application such as CMC issues and bioequivalence.
References
1. Phelps, Ken: Generics companies seek new revenue
streams. Camargo Pharmaceutical Services. https://2yev1x
2bxci91umtr43peanb-wpengine.netdna-ssl.com/wp-
content/uploads/2016/05/camargo-white-paper-generics-
companies.pdf. Accessed September 2018.
2. Determining Whether to Submit an ANDA or a 505(b)(2)
Application; Guidance for Industry. October 2017. US
Department of Health and Human Services, Food and Drug
Administration. https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/
UCM579751.pdf. Accessed September 2018.
3. What is 505(b)(2)? Camargo Pharmaceutical Services.
https://camargopharma.com/what-is-505b2/. Accessed Sep-
tember 2018.
4. Orange Book Preface. US Department of Health and
Human Services, Food and Drug Administration. https://
www.fda.gov/dr ugs/developmentapprovalprocess/
ucm079068.htm. Accessed September 2018.
5. Approved Drug Products with erapeutic Equivalence
Evaluations, 38
th
Edition. US Department of Health and
Human Services, Food and Drug Administration. https://
www.fda.gov/downloads/drugs/developmentapproval
process/ucm071436.pdf. Accessed September 2018.
6. Mylan's generic Advair gets stiff-armed by FDA. What does
this mean for GSK? Fierce Pharma. March 29, 2017. https://
www.fiercepharma.com/pharma/where-fda-s-decision-
mylan-s-generic-advair-and-what-could-it-mean-for-glaxo.
Accessed October 2018.
7. Hikma cuts revenue forecast on generic Advair delay; shares
sink. Reuters. May 19, 2017. https://www.reuters.com/arti-
cle/us-hikma-outlook-idUSKCN18F0IR. Accessed October
2018.
8. Masters K: Spray drying—An introduction to principles,
operational practice and applications. 1972; London: Leon-
ard Hill Books.
9. Newman SP, Pavia D, Garland N, Clarke SW: Effects of
various inhalation modes on the deposition of radioactive
pressurized aerosols. 1982; European Journal of Respiratory
Diseases. 63(Suppl):57-65.
10. Tsapis N, Bennett D, Jackson B, Weitz DA, Edwards DA.:
Trojan particles: Large porous carriers of nanoparticles for
drug delivery. 2002; Proceedings of the National Academy of
Sciences of the United States of America. 99:12001-12005.
11. Raula,J, Eerikäinen H, Kauppinen EI: Influence of the
solvent composition on the aerosol synthesis of pharmaceuti-
26 December 2018 Inhalation
