Characterization of stability and nasal delivery systems for immunization with nanoemulsion-based vaccines

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Volumn 23, Issue 2, 2010, Pages 77-89

  Makidon, Paul E ^a,b   Nigavekar, Shraddha S ^a   Bielinska, Anna U ^a,c   Mank, Nicholas ^a   Shetty, Abhishek M ^b   Suman, Julie ^d   Knowlton, Jessica ^a   Myc, Andrzej ^a,c   Rook, Trent ^a   Baker Jr , James R ^a,c  

^a UNIVERSITY OF MICHIGAN HEALTH SYSTEM   (United States)

^b UNIVERSITY OF MICHIGAN   (United States)

^c UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^d Next Breath LLC   (United States)

Author keywords

Aerosol transport and deposition; Effects of actuation; Mucosal adjuvant; Nanoemulsion; Nasal delivery of vaccines; Nasal sprayer devices

Indexed keywords

NOSE SPRAY; OVALBUMIN; PHOSPHATE BUFFERED SALINE; SODIUM CHLORIDE;

ARTICLE; DRUG DELIVERY SYSTEM; DRUG POTENCY; DRUG STABILITY; IMMUNIZATION; NANOEMULSION; NOSE CAVITY; ROOM TEMPERATURE;

ADMINISTRATION, INTRANASAL; AEROSOLS; ALKALINE PHOSPHATASE; ANIMALS; DRUG STABILITY; DRUG STORAGE; EMULSIONS; EXCIPIENTS; FEMALE; HEPATITIS B SURFACE ANTIGENS; MICE; NANOPARTICLES; NEBULIZERS AND VAPORIZERS; OVALBUMIN; PARTICLE SIZE; SODIUM CHLORIDE; SWINE; VACCINES;

EID: 77951117200     PISSN: 19412711     EISSN: 19412703     Source Type: Journal    
DOI: 10.1089/jamp.2009.0766     Document Type: Article

References (41)

1. Hauri AM, Armstrong GL, Hutin YJF: The global burden of disease attributable to contaminated injections given in health care settings. Int J STD AIDS. 2004;15:7-16.
2. Mitragotri S: Immunization without needles. Nat Rev Immunol. 2005;5:905-916.
3. Heininger U: The success of immunization-shovelling its own grave? Vaccine. 2004;22:2071-2072.
4. Miller MA, Sentz JT: Disease and Mortality in Sub-Sahran Africa (2nd ed.). The World Bank, Washington, DC; 2006.
5. Simonsen L, Kane A, Llloyd J, Zaffraqn M, Kane M: Unsafe injections in the developing world and transmission of bloodborne pathogens: a review. Bull World Health Organ. 1999;77:789-800.
6. Illum L: Nasal drug delivery-possibilities, problems and solutions. J Controlled Release. 2003;87:187-198.
7. Almeida AJ, Souto E: Solid lipid nanoparticles as a drug delivery system for peptides and proteins. Adv Drug Delivy Rev. 2007;59:478-490. (Pubitemid 47260710)
8. Sharma S, Mukkur TKS, Benson HAE, Chen Y: Pharmaceutical aspects of intranasal delivery of vaccines using particulate systems. J Pharmaceut Sci. 2009;98:812-843.
9. Onorato IM, Modlin JF, McBean AM, Thomsm ML, Losonsky GA, Bernier RH: Mucosal immunity induced by enhance-potency inactivated and oral polio vaccines. J Infect Dis. 1991;163:1-6.
10. McGhee JR, Mestecky J: In defense of mucosal surfaces. Development of novel vaccines for IgA responses protective at the portals of entry of microbial pathogens. Infect Dis Clin North Am. 1990;4:315-341.
11. Mestecky J, McGhee JR: Prospects for human mucosal vaccines. Adv Exp Med Biol. 1992;327:13-23.
12. Brandtzaeg P: Overview of the mucosal immune system. Curr Top Microbiol Immunol. 1989;146:13-25.
13. Slutter B, Hagenaars N, Jiskoot W: Rational design of nasal vaccines. J Drug Targeting. 2008;16:1-17.
14. Moingeon P, Haensler J, Lindberg A: Towards the rational design of Th1 adjuvants. Vaccine. 2001;19:4363-4372.
15. Myc A, Kukowska-Latallo JF, Bielinska AU, Cao P, Myc PP, Janczak K, Sturm TR, Grabinski MS, Landers JJ, Young KS, Chang J, Hamouda T, Olszewski MA, Baker JR Jr: Development of immune response that protects mice from viral pneumonitis after a single intranasal immunization with influenza A virus and nanoemulsion. Vaccine. 2003;21: 3801-3814.
16. Bielinska AU, Janczak KW, Landers JJ, Makidon P, Sower LE, Peterson JW, Baker JR Jr: Mucosal immunization with a novel nanoemulsion-based recombinant anthrax protective antigen vaccine protects against bacillus anthracis spore challenge. Infect Immun. 2007;75:4020-4029.
17. Bielinska AU, Janczak KW, Landers JJ, Markovitz DM, Montefiori DC, Baker JR: Nasal immunization with a recombinant HIV gp120 and nanoemulsion adjuvant produces Th1 polarized responses and neutralizing antibodies to primary HIV type 1 isolates. AIDS Res Hum Retroviruses. 2008;24:271-281.
18. Bielinska AU, Chepurnov AA, Landers JJ, Janczak KW, Chepurnova TS, Luker GD, Baker JR Jr: A novel, killed-virus nasal vaccinia virus vaccine. Clin Vaccine Immunol. 2008;15:348-358.
19. Makidon PE, Bielinska AU, Nigavekar SS, Janczak KW, Knowlton J, Scott AJ, Mank N, Cao Z, Rathinavelu S, Beer MR, Wilkinson JE, Blanco LP, Landers JJ, Baker JR Jr: Preclinical evaluation of a novel nanoemulsion-based hepatitis B mucosal vaccine. PLoS ONE. 2008;3:e2954.
20. Sawtell JA, Ream AJ: Observations on the effect of the diluent used for diluting challenge toxin in the Clostridium botulinum potency Test. Biologicals. 1995;23:249-251.
21. Harris AS, Svensson E, Wagner ZG, Lethagen S, Nilsson IM: Effect of viscosity on particle size, deposition, and clearance of nasal delivery systems containing desmopressin. J Pharm Sci. 1988;77:405-408.
22. Cheng YS, Holmes TD, Gao J, Guilmette RA, Li S, Surakitbanharn Y, Rowlings C: Characterization of nasal spray pumps and deposition pattern in a replica of the human nasal airway. J Aerosol Med. 2001;14:267-280.
23. Suman JD, Laube BL, Dalby R: Validity of in vitro tests on aqueous spray pumps as surrogates for nasal deposition, absorption, and biologic response. J Aerosol Med. 2006; 19:510-;521.
24. Dayal P, Shaik MS, Singh M: Evaluation of different parameters that affect droplet-size distribution from nasal sprays using the Malvern Spraytec. J Pharmaceut Sci. 2004;93:1725-1742.
25. Guo C, Stine KJ, Kauffman JF, Doub WH: Assessment of the influence factors on in vitro testing of nasal sprays using Box-Behnken experimental design. Eur J Pharmaceut Sci. 2008;35:417-426.
26. Lillard JW Jr, Boyaka PN, Hedrick JA, Zlotnik A, McGhee JR: Lymphotactin acts as an innate mucosal adjuvant. J Immunol. 1999;162:1959-1965.
27. Classen DC, Morningstar JM, Shanley JD: Detection of antibody to murine cytomegalovirus by enzyme-linked immunosorbent and indirect immunofluorescence assays. J Clin Microbiol. 1987;25:600-604.
28. Frey A, Di Canzio J, Zurakowski D: A statistically defined endpoint titer determination method for immunoassays. J Immunol Methods. 1998;221:35-41.
29. Batchelor GK: An Introduction to Fluid Dynamics. The Press Syndicate of the University of Cambridge, Cambridge, UK; 2000.
30. Schramm LL, Green WHF: An absolute differential maximum bubble pressure surface tensiometer employing displaced capillaries. Colloid Polym Sci. 1992;270:694-706.
31. CfDEaR: Guidance for Industry: Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products- Chemistry, Manufacturing, and Controls Documentation. Food and Drug Administration, Rockville, MD; p. 43, 2002.
32. (CDER) CfDEaR: Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products- General Considerations. Food and Drug Administration, Rockville, MD; 2003.
33. Fauml ngmark I, Carpin JC: Protein nebulization. J Aerosol Sci. 1996;27:231.
34. Tamber H, Johansen P, Merkle HP, Gander B: Formulation aspects of biodegradable polymeric microspheres for antigen delivery. Adv Drug Deliv Rev. 2005;57:357-376.
35. Niven RW, Lott FD, Ip AY, Cribbs JM: Pulmonary delivery of powders and solutions containing recombinant human granulocyte colony-stimulating factor (rhG-CSF) to the rabbit. Pharmaceut Res. 1994;11:1101-1109.
36. Fängmark I, Carpin JC: Stability of urease during aerosolization: the effect of operating conditions. J Aerosol Sci. 1998;29:279-288.
37. Barnes HA: A Handbook of Elementary Rheology. The University of Wales Institute of Non-newtonian Fluid Mechanics, Dyfed, Wales; 2000.
38. Pennington J, Pandey P, Tat H, Willson J, Donovan B: Spray pattern and droplet size analyses for high-shear viscosity determination of aqueous suspension corticosteroid nasal sprays. Drug Dev Industrial Pharmacy. 2008;34: 923-929.
39. Foo MY, Cheng Y-S, Su W-C, Donovan MD: The influence of spray properties on intranasal deposition. J Aerosol Med. 2007;20:495-508.
40. Kublik H, Vidgren MT: Nasal delivery systems and their effect on deposition and absorption. Adv Drug Deliv Rev. 1998;29:157-177.
41. Reddy ST, Rehor A, Schmoekel HG, Hubbell JA, Swartz MA: In vivo targeting of dendritic cells in lymph nodes with poly(propylene sulfide) nanoparticles. J Controlled Release. 2006;112:26-34.