13. Davaalkham D, Ojima T, Wiersma S,
Lkhagvasuren T, Nymadawa P, Uehara R,
Watanabe M, Oki I, Nakamura Y (2007)
Administration of hepatitis B vaccine in winter
as a significant predictor of the poor effectiveness of vaccination in rural Mongolia: evidence
from a nationwide survey. J Epidemiol Community Health 61(7):578–584
14. Menon P, Sahai G, Joshi V, Murthy R,
Boparai M, Thomas A (1976) Field trial on
frozen and thawed tetanus toxoid. Indian J
Med Res 64(1):25–32
15. Wirkas T, Toikilik S, Miller N, Morgan C,
Clements CJ (2007) A vaccine cold chain freezing study in PNG highlights technology needs
for hot climate countries. Vaccine 25
(4):691–697
16. Lydon P, Zipursky S, Tevi-Benissan C, Djingarey MH, Gbedonou P, Youssouf BO, Zaffran
M (2013) Economic benefits of keeping vaccines at ambient temperature during mass vaccination: the case of meningitis A vaccine in
Chad. Bull World Health Organ 92(2):86–92
17. Nelson CM, Wibisono H, Purwanto H,
Mansyur I, Moniaga V, Widjaya A (2004) Hepatitis B vaccine freezing in the Indonesian cold
chain: evidence and solutions. Bull World
Health Organ 82:99–105
18. Edstam JS, Dulmaa N, Tsendjav O,
Dambasuren B, Densmaa B (2004) Exposure
of hepatitis B vaccine to freezing temperatures
during transport to rural health centers in
Mongolia. Prev Med 39(2):384–388
19. Braun LJ, Tyagi A, Perkins S, Carpenter J,
Sylvester D, Guy M, Kristensen D, Chen D
(2009) Development of a freeze-stable formulation for vaccines containing aluminum salt
adjuvants. Vaccine 27(1):72–79
20. Overhoff KA, Johnston KP, Tam J,
Engstrom J, Williams R III (2009) Use of
thin film freezing to enable drug delivery: a
review. J Drug Deliv Sci Technol 19(2):89–98
21. Clausi AL, Morin A, Carpenter JF, Randolph
TW (2009) Influence of protein conformation
and adjuvant aggregation on the effectiveness
of aluminum hydroxide adjuvant in a model
alkaline phosphatase vaccine. J Pharm Sci 98
(1):114–121
22. Clausi AL, Merkley SA, Carpenter JF, Randolph TW (2008) Inhibition of aggregation
of aluminum hydroxide adjuvant during freezing and drying. J Pharm Sci 97(6):2049–2061
23. Cox JC (1999) Spray dried vaccine preparation
comprising aluminium adsorbed immunogens.
US 5,902,565, 11 May 1999
24. Li X, Thakkar SG, Ruwona TB, Williams RO
3rd, Cui Z (2015) A method of lyophilizing
vaccines containing aluminum salts into a dry
powder without causing particle aggregation
or decreasing the immunogenicity following
reconstitution. J Control Release 204:38–50
25. Thakkar SG, Ruwona TB, Williams RO, Cui Z
(2017) The immunogenicity of thin-film
freeze-dried, aluminum salt-adjuvanted vaccine
when exposed to different temperatures. Hum
Vaccin Immunother 13(4):936–946
26. Overhoff KA, Engstrom JD, Chen B, Scherzer
BD, Milner TE, Johnston KP, Williams RO III
(2007) Novel ultra-rapid freezing particle engineering process for enhancement of dissolution
rates of poorly water-soluble drugs. Eur J
Pharm Biopharm 65(1):57–67
27. Engstrom JD, Simpson DT, Cloonan C, Lai
ES, Williams RO 3rd, Barrie Kitto G, Johnston
KP (2007) Stable high surface area lactate
dehydrogenase particles produced by spray
freezing into liquid nitrogen. Eur J Pharm Biopharm 65(2):163–174
28. Engstrom JD, Lai ES, Ludher BS, Chen B,
Milner TE, Williams RO, Kitto GB, Johnston
KP (2008) Formation of stable submicron protein particles by thin film freezing. Pharm Res
25(6):1334–1346
29. Williams RO III, Watts AB, Miller DA (2016)
Formulating poorly water soluble drugs, vol
22. Springer, New York
30. Siddiqui MAA, Perry CM (2006) Human papillomavirus quadrivalent (types 6, 11, 16, 18)
recombinant vaccine (Gardasil®). Drugs 66
(9):1263–1271
31. Keating GM, Noble S (2003) Recombinant
hepatitis B vaccine (Engerix-B®). Drugs 63
(10):1021–1051
32. Xu H, Ruwona TB, Thakkar SG, Chen Y,
Zeng M, Cui Z (2017) Nasal aluminum (oxy)
hydroxide enables adsorbed antigens to induce
specific systemic and mucosal immune
responses. Hum Vaccin Immunother 13
(11):2688–2694
498
Riyad F. Alzhrani et al.
Lkhagvasuren T, Nymadawa P, Uehara R,
Watanabe M, Oki I, Nakamura Y (2007)
Administration of hepatitis B vaccine in winter
as a significant predictor of the poor effectiveness of vaccination in rural Mongolia: evidence
from a nationwide survey. J Epidemiol Community Health 61(7):578–584
14. Menon P, Sahai G, Joshi V, Murthy R,
Boparai M, Thomas A (1976) Field trial on
frozen and thawed tetanus toxoid. Indian J
Med Res 64(1):25–32
15. Wirkas T, Toikilik S, Miller N, Morgan C,
Clements CJ (2007) A vaccine cold chain freezing study in PNG highlights technology needs
for hot climate countries. Vaccine 25
(4):691–697
16. Lydon P, Zipursky S, Tevi-Benissan C, Djingarey MH, Gbedonou P, Youssouf BO, Zaffran
M (2013) Economic benefits of keeping vaccines at ambient temperature during mass vaccination: the case of meningitis A vaccine in
Chad. Bull World Health Organ 92(2):86–92
17. Nelson CM, Wibisono H, Purwanto H,
Mansyur I, Moniaga V, Widjaya A (2004) Hepatitis B vaccine freezing in the Indonesian cold
chain: evidence and solutions. Bull World
Health Organ 82:99–105
18. Edstam JS, Dulmaa N, Tsendjav O,
Dambasuren B, Densmaa B (2004) Exposure
of hepatitis B vaccine to freezing temperatures
during transport to rural health centers in
Mongolia. Prev Med 39(2):384–388
19. Braun LJ, Tyagi A, Perkins S, Carpenter J,
Sylvester D, Guy M, Kristensen D, Chen D
(2009) Development of a freeze-stable formulation for vaccines containing aluminum salt
adjuvants. Vaccine 27(1):72–79
20. Overhoff KA, Johnston KP, Tam J,
Engstrom J, Williams R III (2009) Use of
thin film freezing to enable drug delivery: a
review. J Drug Deliv Sci Technol 19(2):89–98
21. Clausi AL, Morin A, Carpenter JF, Randolph
TW (2009) Influence of protein conformation
and adjuvant aggregation on the effectiveness
of aluminum hydroxide adjuvant in a model
alkaline phosphatase vaccine. J Pharm Sci 98
(1):114–121
22. Clausi AL, Merkley SA, Carpenter JF, Randolph TW (2008) Inhibition of aggregation
of aluminum hydroxide adjuvant during freezing and drying. J Pharm Sci 97(6):2049–2061
23. Cox JC (1999) Spray dried vaccine preparation
comprising aluminium adsorbed immunogens.
US 5,902,565, 11 May 1999
24. Li X, Thakkar SG, Ruwona TB, Williams RO
3rd, Cui Z (2015) A method of lyophilizing
vaccines containing aluminum salts into a dry
powder without causing particle aggregation
or decreasing the immunogenicity following
reconstitution. J Control Release 204:38–50
25. Thakkar SG, Ruwona TB, Williams RO, Cui Z
(2017) The immunogenicity of thin-film
freeze-dried, aluminum salt-adjuvanted vaccine
when exposed to different temperatures. Hum
Vaccin Immunother 13(4):936–946
26. Overhoff KA, Engstrom JD, Chen B, Scherzer
BD, Milner TE, Johnston KP, Williams RO III
(2007) Novel ultra-rapid freezing particle engineering process for enhancement of dissolution
rates of poorly water-soluble drugs. Eur J
Pharm Biopharm 65(1):57–67
27. Engstrom JD, Simpson DT, Cloonan C, Lai
ES, Williams RO 3rd, Barrie Kitto G, Johnston
KP (2007) Stable high surface area lactate
dehydrogenase particles produced by spray
freezing into liquid nitrogen. Eur J Pharm Biopharm 65(2):163–174
28. Engstrom JD, Lai ES, Ludher BS, Chen B,
Milner TE, Williams RO, Kitto GB, Johnston
KP (2008) Formation of stable submicron protein particles by thin film freezing. Pharm Res
25(6):1334–1346
29. Williams RO III, Watts AB, Miller DA (2016)
Formulating poorly water soluble drugs, vol
22. Springer, New York
30. Siddiqui MAA, Perry CM (2006) Human papillomavirus quadrivalent (types 6, 11, 16, 18)
recombinant vaccine (Gardasil®). Drugs 66
(9):1263–1271
31. Keating GM, Noble S (2003) Recombinant
hepatitis B vaccine (Engerix-B®). Drugs 63
(10):1021–1051
32. Xu H, Ruwona TB, Thakkar SG, Chen Y,
Zeng M, Cui Z (2017) Nasal aluminum (oxy)
hydroxide enables adsorbed antigens to induce
specific systemic and mucosal immune
responses. Hum Vaccin Immunother 13
(11):2688–2694
498
Riyad F. Alzhrani et al.