Dry powder nasal vaccines as an alternative to needle-based delivery

Critical Reviews in Therapeutic Drug Carrier Systems

Volumn 26, Issue 1, 2009, Pages 1-27

  Hickey, Anthony J ^a   Garmise, Robert J ^a,b  

^a UNIVERSITY OF NORTH CAROLINA   (United States)

^b University of North Carolina ^*

Author keywords

Freeze drying; Mucoadhesive; Mucociliary clearance; Nasal associated lymphoid tissue; Spray freeze drying; Vaccine

Indexed keywords

ADHESIVE AGENT; ADJUVANT; CARBOMER; CHITOSAN; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; INFLUENZA VACCINE; PERTUSSIS VACCINE; VACCINE;

DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG MANUFACTURE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DRY POWDER; FREEZE DRYING; HUMAN; IMMUNE RESPONSE; IMMUNIZATION; IMMUNOGENICITY; LIQUID; LYMPHOID TISSUE; MATERIALS HANDLING; MUCOADHESION; MUCOCILIARY CLEARANCE; NONHUMAN; NOSE CAVITY; NOSE MUCOSA; PARTICLE SIZE; PHYSICAL CHEMISTRY; REVIEW; SPRAY DRYING;

EID: 67149120680     PISSN: 07434863     EISSN: None     Source Type: Journal    
DOI: 10.1615/CritRevTherDrugCarrierSyst.v26.i1.10     Document Type: Review

References (107)

1. Proctor DF, Andersen IHP. The nose, upper airway physiology and the atmospheric environment. New York: Elsevier Biomedical Press; 1982.
2. Mestecky J. The common mucosal immune system and current strategies for induction of immune responses in external secretions. J Clin Immunol. 1987;7(4):265-76.
3. Partidos CD. Intranasal vaccines: forthcoming challenges. Pharm Sci Technol Today. 2000;3(8):273-281.
4. Illum L. Nasal drug delivery: new developments and strategies. Drug Discov Today. 2002;7(23):1184-9.
5. Groneberg DA, Witt C, Wagner U, Chung KF, Fischer A. Fundamentals of pulmonary drug delivery. Respir Med. 2003;97(4):382-7.
6. Roth Y, Chapnik JS, Cole P. Feasibility of aerosol vaccination in humans. Ann Otol Rhinol Laryngol. 2003;112(3):264-70.
7. Gonda I. The ascent of pulmonary drug delivery. J Pharm Sci. 2000;89(7):940-5.
8. Singh M, Briones M, O'Hagan DT. A novel bioadhesive intranasal delivery system for inactivated influenza vaccines. J Control Release. 2001;70(3):267-76.
9. Guyton AC, Hall JE. Textbook of medical physiology. 9th ed. Philadelphia: W.B. Saunders; 1996.
10. Taber CW, Thomas CL. Taber's cyclopedic medical dictionary. 19th ed. Philadelphia: F.A. Davis Co.; 2001.
11. Mygind N, Dahl R. Anatomy, physiology and function of the nasal cavities in health and disease. Adv Drug Del Rev. 1998;29(1-2):3-12.
12. Newman SP, Pitcairn GR, Dalby RN. Drug delivery to the nasal cavity: in vitro and in vivo assessment. Crit Rev Ther Drug Carrier Syst. 2004;21(1):21-66.
13. Proctor DF, Lundqvist G. Clearance of inhaled particles from the human nose. Arch Intern Med. 1973;131(1):132-9.
14. Ugwoke MI, Verbeke N, Kinget R. The biopharmaceutical aspects of nasal mucoadhesive drug delivery. J Pharm Pharmacol. 2001;53(1):3-21.
15. Jones N. The nose and paranasal sinuses: physiology and anatomy. Adv Drug Del Rev. 2001;51(1-3):5-19.
16. Illum L. Bioadhesive formulations for nasal peptide delivery. In: Mathiowitz E, Chickering DE, Lehr C-M, editors. Bioadhesive drug delivery systems: fundamentals, novel approaches, and development. New York: Marcel Dekker; 1999:507-39.
17. Quraishi MS, Jones NS, Mason J. The rheology of nasal mucus: a review. Clin Otolaryngol Allied Sci. 1998;23(5):403-13.
18. Stannard W, O'Callaghan C. Ciliary function and the role of cilia in clearance. J Aerosol Med. 2006;19(1):110-5.
19. Mestecky J, Moldoveanu Z, Michalek SM, Morrow CD, Compans RW, Schafer DP, Russell MW. Current options for vaccine delivery systems by mucosal routes. J Control Release. 1997;48(2-3):243-57.
20. Kuper CF, Koornstra PJ, Hameleers DM, Biewenga J, Spit BJ, Duijvestijn AM, van Breda Vriesman PJ, Sminia T. The role of nasopharyngeal lymphoid tissue. Immunol Today. 1992;13(6):219-24.
21. Roitt IM, Delves PJ. Roitt's essential immunology. 10th ed. Oxford (UK), Malden (MA): Blackwell Science; 2001.
22. Debertin AS, Tschernig T, Tonjes H, Kleemann WJ, Troger HD, Pabst R. Nasal-associated lymphoid tissue (NALT): frequency and localization in young children. Clin Exp Immunol. 2003;134(3):503-7.
23. Nordqvist C. FluMist more effective than injections for small children and babies. Medical News Today. 2006 May 1.
24. Fujimura Y, Akisada T, Harada T, Haruma K. Uptake of microparticles into the epithelium of human nasopharyngeal lymphoid tissue. Med Mol Morphology. 2006;39:181-6.
25. Fujimura Y, Takeda M, Ikai H, Haruma K, Akisada T, Harada T, Sakai T, Ohuchi M. The role of M cells of human nasopharyngeal lymphoid tissue in influenza virus sampling. Virchows Arch. 2004;444:36-42.
26. Tamura S, Kurata T. Defense mechanisms against influenza viruse infection in the respiratory tract mucosa. Jpn J Infect Dis. 2004;57:236-47.
27. Leffell MS, Donnenberg AD, Rose NR. Handbook of human immunology. Boca Raton (FL): CRC Press; 1997.
28. Hinds WC. Aerosol technology: properties, behavior, and measurement of airborne particles. 2nd ed. New York: J. Wiley; 1999.
29. Voltaire. Philosophical letters. Indianapolis (IN): Bobbs-Merrill; 1961.
30. Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, Bernstein DI, Hayden FG, Kotloff K, Zangwill K, Iacuzio D, Wolff M. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998;338(20):1405-12.
31. Nichol KL, Mendelman PM, Mallon KP, Jackson LA, Gorse GJ, Belshe RB, Glezen WP, Wittes J. Effectiveness of live, attenuated intranasal influenza virus vaccine in healthy, working adults: a randomized controlled trial. JAMA. 1999;282(2):137-44.
32. Treanor JJ, Kotloff K, Betts RF, Belshe R, Newman F, Iacuzio D, Wittes J, Bryant M. Evaluation of trivalent, live, cold-adapted (CAIV-T) and inactivated (TIV) influenza vaccines in prevention of virus infection and illness following challenge of adults with wild-type influenza A (H1N1), A (H3N2), and B viruses. Vaccine. 1999;18(9-10):899-906.
33. FluMist package insert. Gaithersburg (MD): MedImmune; 2003.
34. Davis SS. Nasal vaccines. Adv Drug Deliv Rev. 2001;51(1-3):21-42.
35. Boyaka PN, Tafaro A, Fischer R, Leppla SH, Fujihashi K, McGhee JR. Effective mucosal immunity to anthrax: neutralizing antibodies and Th cell responses following nasal immunization with protective antigen. J Immunol. 2003;170(11):5636-43.
36. Muszkat M, Friedman G, Schein MH, Naveh P, Greenbaum E, Schlesinger M, Zakay-Rones Z, Yehuda AB. Local SIgA response following administration of a novel intranasal inactivated influenza virus vaccine in community residing elderly. Vaccine. 2000;18(16):1696-9.
37. Hirabayashi Y, Kurata H, Funato H, Nagamine T, Aizawa C, Tamura S, Shimada K, Kurata T. Comparison of intranasal inoculation of influenza HA vaccine combined with cholera toxin B subunit with oral or parenteral vaccination. Vaccine. 1990;8(3):243-8.
38. Russell MW, Moldoveanu Z, White PL, Sibert GJ, Mestecky J, Michalek SM. Salivary, nasal, genital, and systemic antibody responses in monkeys immunized intranasally with a bacterial protein antigen and the Cholera toxin B subunit. Infect Immun. 1996;64(4):1272-83.
39. Bergquist C, Johansson EL, Lagergard T, Holmgren J, Rudin A. Intranasal vaccination of humans with recombinant cholera toxin B subunit induces systemic and local antibody responses in the upper respiratory tract and the vagina. Infect Immun. 1997;65(7):2676-84.
40. Anderson J, Fishbourne E, Corteyn A, Donaldson AI. Protection of cattle against rinderpest by intranasal immunisation with a dry powder tissue culture vaccine. Vaccine. 2000;19(7-8):840-843.
41. Illum L, Jabbal-Gill I, Hinchcliffe M, Fisher AN, Davis SS. Chitosan as a novel nasal delivery system for vaccines. Adv Drug Deliv Rev. 2001;51(1-3):81-96.
42. Stephenson I, Zambon MC, Rudin A, Colegate A, Podda A, Bugarini R, Del Giudice G, Minutello A, Bonnington S, Holmgren J, Mills KH, Nicholson KG. Phase I evaluation of intranasal trivalent inactivated influenza vaccine with nontoxigenic Escherichia coli enterotoxin and novel biovector as mucosal adjuvants, using adult volunteers. Virol. 2006;80(10):4962-70.
43. Hunter SK, Andracki ME, Krieg AM. Biodegradable microspheres containing group B Streptococcus vaccine: immune response in mice. Am J Obstet Gynecol. 2001;185(5):1174-9.
44. Debin A, Kravtzoff R, Santiago JV, Cazales L, Sperandio S, Melber K, Janowicz Z, Betbeder D, Moynier M. Intranasal immunization with recombinant antigens associated with new cationic particles induces strong mucosal as well as systemic antibody and CTL responses. Vaccine. 2002;20(21-22):2752-63.
45. Mariotti S, Teloni R, von Hunolstein C, Romagnoli G, Orefici G, Nisini R. Immunogenicity of anti-Haemophilus influenzae type b CRM197 conjugate following mucosal vaccination with oligodeoxynucleotide containing immunostimulatory sequences as adjuvant. Vaccine. 2002;20(17-18):2229-39.
46. Staats HF, Bradney CP, Gwinn WM, Jackson SS, Sempowski GD, Liao HX, Letvin NL, Haynes BF. Cytokine requirements for induction of systemic and mucosal CTL after nasal immunization. J Immunol. 2001;167(9):5386-94.
47. Rharbaoui F, Drabner B, Borsutzky S, Winckler U, Morr M, Ensoli B, Muhlradt PF, Guzman CA. The Mycoplasma-derived lipopeptide MALP-2 is a potent mucosal adjuvant. Eur J Immunol. 2002;32(10):2857-65.
48. Mathiowitz E, Chickering DE, Lehr C-M. Bioadhesive drug delivery systems: fundamentals, novel approaches, and development. New York: Marcel Dekker; 1999.
49. van der Lubben IM, Kersten G, Fretz MM, Beuvery C, Coos Verhoef J, Junginger HE. Chitosan microparticles for mucosal vaccination against diphtheria: oral and nasal efficacy studies in mice. Vaccine. 2003;21(13-14):1400-8.
50. van der Lubben IM, Verhoef JC, Borchard G, Junginger HE. Chitosan for mucosal vaccination. Adv Drug Deliv Rev. 2001;52(2):139-44.
51. Jabbal-Gill I, Fisher AN, Rappuoli R, Davis SS, Illum L. Stimulation of mucosal and systemic antibody responses against Bordetella pertussis filamentous haemagglutinin and recombinant pertussis toxin after nasal administration with chitosan in mice. Vaccine. 1998;16(20):2039-46.
52. Westerink MA, Smithson SL, Srivastava N, Blonder J, Coeshott C, Rosenthal GJ. ProJuvant (Pluronic F127/chitosan) enhances the immune response to intranasally administered tetanus toxoid. Vaccine. 2001;20(5-6):711-23.
53. Artursson P, Lindmark T, Davis S, Illum L. Effect of chitosan on the permeability of monolayers of intestinal epithelial cells (Caco-2). Pharm Res. 1994;11(9):1358-61.
54. Gu JM, Robinson JR, Leung SH. Binding of acrylic polymers to mucin/ epithelial surfaces: structure-property relationships. Crit Rev Ther Drug Carrier Syst. 1988;5(1):21-67.
55. Callens C, Remon JP. Evaluation of starch-maltodextrin-Carbopol 974 P mixtures for the nasal delivery of insulin in rabbits. J Control Release. 2000;66(2-3):215-20.
56. Bacon A, Makin J, Sizer PJ, Jabbal-Gill I, Hinchcliffe M, Illum L, Chatfield S, Roberts M. Carbohydrate biopolymers enhance antibody responses to mucosally delivered vaccine antigens. Infect Immun. 2000;68(10):5764-70.
57. Glueck R. Review of intranasal influenza immunization. Adv Drug Del Rev. 2001;51:203-11.
58. Aspden TJ, Mason JD, Jones NS, Lowe J, Skaugrud O, Illum L. Chitosan as a nasal delivery system: the effect of chitosan solutions on in vitro and in vivo mucociliary transport rates in human turbinates and volunteers. J Pharm Sci. 1997;86(4):509-13.
59. Soane RJ, Hinchcliffe M, Davis SS, Illum L. Clearance characteristics of chitosan based formulations in the sheep nasal cavity. Int J Pharm. 2001;217(1-2):183-91.
60. Garmise RJ, Hickey AJ. In vitro evaluation of mucoadhesive compounds for use in a dry powder nasal vaccine. Paper presented at: Respiratory Drug Delivery X; 2006 April 24-28; Boca Raton, FL.
61. Garmise RJ, Staats HF, Hickey AJ. Novel dry powder preparations of whole inactivated influenza virus for nasal vaccination. AAPS Pharm Sci Tech. 2007;8(4):Article 81.
62. Ugwoke MI, Agu RU, Verbeke N, Kinget R. Nasal mucoadhesive drug delivery: Background, applications, trends and future perspectives. Adv Drug Del Rev. 2005;57(11):1640-65.
63. Illum L. Nasal clearance in health and disease. J Aerosol Med. 2006;19(1):92-9.
64. Smith DJ, Bot S, Dellamary L, Bot A. Evaluation of novel aerosol formulations designed for mucosal vaccination against influenza virus. Vaccine. 2003;21(21-22):2805-12.
65. LiCalsi C, Christensen T, Bennett JV, Phillips E, Witham C. Dry powder inhalation as a potential delivery method for vaccines. Vaccine. 1999;17(13-14):1796-1803.
66. LiCalsi C, Maniaci MJ, Christensen T, Phillips E, Ward GH, Witham C. A powder formulation of measles vaccine for aerosol delivery. Vaccine. 2001;19(17-19):2629-36.
67. Garmise RJ, Mar K, Crowder TM, et al. Formulation of a dry powder influenza vaccine for nasal delivery. AAPS Pharm Sci Tech. 2006;7(1):Article 19.
68. Huang J, Garmise RJ, Crowder TM, Mar K, Hwang CR, Hickey AJ, Mikszta JA, Sullivan VJ. A novel dry powder influenza vaccine and intranasal delivery technology: induction of systemic and mucosal immune responses in rats. Vaccine. 2004;23(6):794-801.
69. Ni Y, Yates KM; Carrington Laboratories Inc., assignee. In-situ gel formation of pectin. U.S. patent 6,777,000, 2004.
70. Ni Y, Tian L, Turner D, Villaneueva I, Medi BM, Guo J, Arden N, Quarles J, Tizard I, Yates K. Induction of protective immunity against influenza virus with a nasal powder vaccine delivery system (GelVac). Paper presented at: 45th ICAAC Meeting; 2005 December 16-19; Washington, DC.
71. Yates K. A novel inactivated nasal influenza vaccine. Paper presented at: World Vaccine Congress; 2006 March 20-23; Washington, DC.
72. Masters K. Spray drying: an introduction to principles, operational practice, and applications. 2nd ed. London: Wiley; 1976.
73. Gennaro AR, Remington JP. Remington, the science and practice of pharmacy. 19th ed. Easton (PA): Mack Pub Co.; 1995.
74. Oetjen G-W, Haseley P. Freeze-drying. 2nd ed. Weinheim (NY): Wiley- VCH; 2004.
75. Rey L, May JC. Freeze-drying/lyophilization of pharmaceutical and biological products. 2nd ed. New York: Marcel Dekker; 2004.
76. Carpenter JF, Arakawa T, Crowe JH. Interactions of stabilizing additives with proteins during freeze-thawing and freeze-drying. Dev Biol Stand. 1992;74:225-38; discussion 238-9.
77. Hageman M. Water sorption and solid state stability of proteins. In: Ahern TJ, Manning MC, editors. Stability of protein pharmaceuticals. New York: Plenum Press; 1992:273-309.
78. Costantino HR, Firouzabadian L, Wu C, Carrasquillo KG, Griebenow K, Zale SE, Tracy MA. Protein spray freeze drying. 2. Effect of formulation variables on particle size and stability. J Pharm Sci. 2002;91(2):388-95.
79. Costantino HR, Firouzabadian L, Hogeland K, Wu C, Beganski C, Carrasquillo KG, Cordova M, Griebenow K, Zale SE, Tracy MA. Protein spray-freeze drying. Effect of atomization conditions on particle size and stability. Pharm Res. 2000;17(11):1374-83.
80. Gombotz WR, Healy MS, Brown LR, Auer HE; Alkermes Controlled Therapeutics, Inc., assignee. Process for producing small particles of biologically active molecules. U.S. patent 6569458, 1990.
81. Maa YF, Nguyen PA, Sweeney T, Shire SJ, Hsu CC. Protein inhalation powders: spray drying vs spray freeze drying. Pharm Res. 1999;16(2):249-54.
82. Carrasquillo KG, Stanley AM, Aponte-Carro JC, De Jesus P, Costantino HR, Bosques CJ, Griebenow K. Non-aqueous encapsulation of excipient- stabilized spray-freeze dried BSA into poly(lactide-co-glycolide) microspheres results in release of native protein. J Control Release. 2001;76(3):199-208.
83. Carrasquillo KG, Carro JC, Alejandro A, Toro DD, Griebenow K. Reduction of structural perturbations in bovine serum albumin by non- aqueous microencapsulation. J Pharm Pharmacol. 2001;53(1):115-20.
84. Sonner C, Maa YF, Lee G. Spray-freeze-drying for protein powder preparation: particle characterization and a case study with trypsinogen stability. J Pharm Sci. 2002;91(10):2122-39.
85. Zijlstra GS, Hinrichs WL, de Boer AH, Frijlink HW. The role of particle engineering in relation to formulation and de-agglomeration principle in the development of a dry powder formulation for inhalation of cetrorelix. Eur J Pharm Sci. 2004;23(2):139-49.
86. Sweeney LG, Wang Z, Loebenberg R, Wong JP, Lange CF, Finlay WH. Spray-freeze-dried liposomal ciprofloxacin powder for inhaled aerosol drug delivery. Int J Pharm. 2005;305(1-2):180-5.
87. Nguyen XC, Herberger JD, Burke PA. Protein powders for encapsulation: a comparison of spray-freeze drying and spray drying of darbepoetin alfa. Pharm Res. 2004;21(3):507-14.
88. Burke PA, Klumb LA, Herberger JD, Nguyen XC, Harrell RA, Zordich M. Poly(lactide-co-glycolide) microsphere formulations of darbepoetin alfa: spray drying is an alternative to encapsulation by spray-freeze drying. Pharm Res. 2004;21(3):500-6.
89. Maa YF, Zhao L, Payne LG, Chen D. Stabilization of alum-adjuvanted vaccine dry powder formulations: mechanism and application. J Pharm Sci. 2003;92(2):319-32.
90. Wang J, Chua KM, Wang C-H. Stabilization and encapsulation of human immunoglobulin G into biodegradable microspheres. J Colloid Interface Sci. 2004;271(1):92-101.
91. Maa YF, Ameri M, Shu C, Payne LG, Chen D. Influenza vaccine powder formulation development: spray-freeze-drying and stability evaluation. J Pharm Sci. 2004;93(7):1912-23.
92. Heller MC, Carpenter JF, Randolph TW. Protein formulation and lyophilization cycle design: prevention of damage due to freeze- concentration induced phase separation. Biotechnol Bioeng. 1999;63(2):166-74.
93. Costantino HR, Johnson OL, Zale SE. Relationship between encapsulated drug particle size and initial release of recombinant human growth hormone from biodegradable microspheres. J Pharm Sci. 2004;93(10):2624-34.
94. Lam XM, Duenas ET, Cleland JL. Encapsulation and stabilization of nerve growth factor into poly(lactic-co-glycolic) acid microspheres. J Pharm Sci. 2001;90(9):1356-65.
95. van Drooge D-J, Hinrichs WLJ, Dickhoff BHJ, et al. Spray freeze drying to produce a stable [Delta]9-tetrahydrocannabinol containing inulin-based solid dispersion powder suitable for inhalation. Eur J Pharm Sci. 2005;26(2):231-40.
96. Carstensen JT. Pharmaceutical principles of solid dosage forms. Lancaster (PA): Technomic Pub Co.; 1993.
97. Martin AN, Bustamante P. Physical pharmacy: physical chemical principles in the pharmaceutical sciences. 4th ed. Philadelphia: Lea & Febiger; 1993.
98. Carr RL Jr. Classifying flow properties of solids. Chem Eng. 1965;72(3):69-72.
99. Crowder TM. A guide to pharmaceutical particulate science. Boca Raton (FL): Interpharm Press/CRC; 2003.
100. Hickey AJ, Ganderton D. Pharmaceutical process engineering. New York: Marcel Dekker; 2001.
101. Kulvanich P, Stewart PJ. Influence of relative humidity on the adhesive properties of a model interactive system. J Pharm Pharmacol. 1988;40(7):453-8.
102. Craig DQM, Royall PG, Kett VL, Hopton ML. The relevance of the amorphous state to pharmaceutical dosage forms: glassy drugs and freeze dried systems. Int J Pharm. 1999;179(2):179-207.
103. Carpenter JF, Pikal MJ, Chang BS, Randolph TW. Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res. 1997;14(8):969-75.
104. Behl CR, Pimplaskar HK, Sileno AP, deMeireles J, Romeo VD. Effects of physicochemical properties and other factors on systemic nasal drug delivery. Adv Drug Del Rev. 1998;29(1-2):89-116.
105. Chang B, Reeder G, Carpenter J. Development of a stable freeze-dried formulation of recombinant human interleukin-1 receptor antagonist. Pharm Res. 1996;13(2):243-9.
106. Brittain HG. Physical characterization of pharmaceutical solids. New York: M. Dekker; 1995.
107. Sullivan VJ, Mikszta JA, Laurent P, Huang J, Ford BM. Noninvasive delivery technologies: respiratory delivery of vaccines. Expert Opin Drug Deliv. 2006;3(1):87-95.