Inhibition of aggregation of aluminum hydroxide adjuvant during freezing and drying

Journal of Pharmaceutical Sciences

Volumn 97, Issue 6, 2008, Pages 2049-2061

  Clausi, Amber L ^a   Merkley, Scott A ^a   Carpenter, John F ^b   Randolph, Theodore W ^a  

^a UCB 450   (United States)

^b UNIVERSITY OF COLORADO   (United States)

Author keywords

Aluminum hydroxide adjuvant; Formulation; Freeze drying lyophilization; Particle size; Vaccines; X ray powder diffractometry

Indexed keywords

ALUMINUM HYDROXIDE; SODIUM CHLORIDE; TREHALOSE; BUFFER; EXCIPIENT; IMMUNOLOGICAL ADJUVANT; SUCCINIC ACID DERIVATIVE;

ARTICLE; DRUG FORMULATION; DRUG INHIBITION; FREEZE DRYING; FREEZE THAWING; X RAY DIFFRACTION; CHEMISTRY; FREEZING; METHODOLOGY; PARTICLE SIZE; PH; PHARMACEUTICS; POWDER DIFFRACTION; X RAY CRYSTALLOGRAPHY;

ADJUVANTS, IMMUNOLOGIC; ALUMINUM HYDROXIDE; BUFFERS; CHEMISTRY, PHARMACEUTICAL; CRYSTALLOGRAPHY, X-RAY; EXCIPIENTS; FREEZE DRYING; FREEZING; HYDROGEN-ION CONCENTRATION; PARTICLE SIZE; POWDER DIFFRACTION; SUCCINATES; TECHNOLOGY, PHARMACEUTICAL; TREHALOSE;

EID: 49249133875     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21143     Document Type: Article

References (32)

1. Callahan PM, Shorter AL, Hem SL. 1991. The importance of surface charge in the optimization of antigen-adjuvant interactions. Pharm Res 8:851-858.
2. Lindblad EB. 2004. Aluminium compounds for use in vaccines. Immunol Cell Biol 82:497-505.
3. Gupta RK, Siber GR. 1995. Adjuvants for human vaccines-Current status, problems and future-prospects. Vaccine 13:1263-1276.
4. Gupta RK, Rost BE. 2000. Aluminum compounds as vaccine adjuvants. In: O'Hagan D, editor. Vaccine adjuvants: Preparation methods and research protocols, 1st ed. Totowa, NJ: Humana Press Inc. p 65-89.
5. Cox JC, Coulter AR. 1997. Adjuvants-A classification and review of their modes of action. Vaccine 15:248-256.
6. HogenEsch H. 2002. Mechanisms of stimulation of the immune response by aluminum adjuvants. Vaccine 20:S34-S39.
7. Grun JL, Maurer PH. 1989. Different T helper cell subsets elicited in mice utilizing two different adjuvant vehicles: The role of endogenous interleukin 1 in proliferative responses. Cell Immunol 121:134-145.
8. Jones LS, Peek LJ, Power J, Markham A, Yazzie B, Middaugh CR. 2005. Effects of adsorption to aluminum salt adjuvants on the structure and stability of model protein antigens. J Biol Chem 280:13406-13414.
9. Thai R, Moine G, Desmadril M, Servent D, Tarride JL, Menez A, Leonetti M. 2004. Antigen stability controls antigen presentation. J Biol Chem 279: 50257-50266.
10. Hem SL, White JL. 1984. Characterization of aluminum hydroxide for use as an adjuvant in parenteral vaccines. J Parenter Sci Technol 38:2-10.
11. Nygaard UC, Samuelsen M, Aase A, Lovik M. 2004. The capacity of particles to increase allergic sensi-tization is predicted by particle number and surface area, not by particle mass. Toxicol Sci 82:515-524.
12. Morefield GL, Sokolovska A, Jiang D, HogenEsch H, Robinson JP, Hem SL. 2005. Role of aluminum-containing adjuvants in antigen internalization by dendritic cells in vitro. Vaccine 23:1588-1595.
13. Diminsky D, Moav N, Gorecki M, Barenholz Y. 1999. Physical, chemical and immunological stability of CHO-derived hepatitis B surface antigen (HBsAg) particles. Vaccine 18:3-17.
14. Maa YF, Zhao L, Payne LG, Chen D. 2003. Stabilization of alum-adjuvanted vaccine dry powder formulations: Mechanism and application. J Pharm Sci 92:319-332.
15. Zapata MI, Feldkamp JR, Peck GE, White JL, Hem SL. 1984. Mechanism of freeze-thaw instability of aluminum hydroxycarbonate and magnesium hydroxide gels. J Pharm Sci 73:3-8.
16. Vessely C, Estey T, Randolph T, Henderson I, Nayar R, Carpenter J. 2007. Effects of solution conditions and surface chemistry on the adsorption of three recombinant botulinum neurotoxin antigens to aluminum salt adjuvants. J Pharm Sci 96: 2375-2389.
17. Roy S, Jung R, Kerwin BA, Randolph TW, Carpenter JF. 2005. Effects of benzyl alcohol on aggregation of recombinant human interleukin-1-receptor antagonist in reconstituted lyophilized formulations. J Pharm Sci 94:382-396.
18. Johnston CT, Wang SL, Hem SL. 2002. Measuring the surface area of aluminum hydroxide adjuvant. J Pharm Sci 91:1702-1706.
19. Burrell LS, Lindblad EB, White JL, Hem SL. 1999. Stability of aluminium-containing adjuvants to autoclaving. Vaccine 17:2599-2603.
20. Shirodkar S, Hutchinson RL, Perry DL, White JL, Hem SL. 1990. Aluminum compounds used as adjuvants in vaccines. Pharm Res 7:1282-1288.
21. Goldberg S, Davis JA, Hem JD. 1996. The surface chemistry of aluminum oxides and hydroxides. In: Sposito G, editor The Environmental Chemistry of Aluminum, 2nd edition. Boca Raton, FL: Lewis Publishers. p 271-331.
22. Rinella JV, Jr., White JL, Hem SL. 1996. Treatment of aluminium hydroxide adjuvant to optimize the adsorption of basic proteins. Vaccine 14:298-300.
23. Chang MF, White JL, Nail SL, Hem SL. 1997. Role of the electrostatic attractive force in the adsorption of proteins by aluminum hydroxide adjuvant. PDA J Pharm Sci Technol 51:25-29.
24. Chang M, Shi Y, Nail SL, HogenEsch H, Adams SB, White JL, Hem SL. 2001. Degree of antigen adsorption in the vaccine or interstitial fluid and its effect on the antibody response in rabbits. Vaccine 19:2884-2889.
25. Iyer S, HogenEsch H, Hem SL. 2003. Relationship between the degree of antigen adsorption to aluminum hydroxide adjuvant in interstitial fluid and antibody production. Vaccine 21:1219-1223.
26. Miller DP, de Pablo JJ, Corti H. 1997. Thermophysical properties of trehalose and its concentrated aqueous solutions. Pharm Res 14:578-590.
27. Xu R. 2002. Electrophoretic light scattering: Zeta potential measurement. Particle characterization: Light scattering methods. 1st ed. New York: Kluwer Academic. pp 289-343.
28. Venturini-Soriano M, Berthon G. 1998. Aluminum speciation studies in biological fluids. Part 4. A new investigation of aluminum-succinate complex formation under physiological conditions, and possible implications for aluminum metabolism and toxicity. J Inorg Biochem 71:135-145.
29. Alliey N, Venturini-Soriano M, Berthon G. 1996. Aluminum-succinate complex equilibria and their potential implications for aluminum metabolism. Ann Clin Lab Sci 26:122-132.
30. Shalaev EY, Johnson-Elton TD, Chang LQ, Pikal MJ. 2002. Thermophysical properties of pharma-ceutically compatible buffers at sub-zero temperatures: Implications for freeze-drying. Pharmaceut Res 19:195-201.
31. Yau KP, Schulze DG, Johnston CT, Hem SL. 2006. Aluminum hydroxide adjuvant produced under constant reactant concentration. J Pharm Sci 95: 1822-1833.
32. Berglund KA, Alizadeh H. 1995. Crystalline composition of lysine and succinic acid or alkali metal salt thereof. U.S. Patent No. 5,527,959.