Influence of formulation pH and suspension state on freezing-induced agglomeration of aluminum adjuvants

Journal of Pharmaceutical Sciences

Volumn 101, Issue 3, 2012, Pages 1050-1062

  Salnikova, Maya S ^a   Davis, Harrison ^a   Mensch, Christopher ^a   Celano, Lauren ^a   Thiriot, David S ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Formulation; Light scattering (static); Microscopy; Particle size; PH; Physical stability; Precipitation; Stabilization; Vaccine adjuvants

Indexed keywords

ADJUPHOS; ALUMINUM HYDROXIDE; ALUMINUM PHOSPHATE; BUFFER; SUCROSE; UNCLASSIFIED DRUG;

ARTICLE; CHEMICAL PHENOMENA; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG AGGLOMERATION; DRUG FORMULATION; DRUG INTERACTION; FLOCCULATION; FLOW KINETICS; FREEZING; IONIC STRENGTH; LIGHT SCATTERING; PARTICLE SIZE; PH; SETTLEMENT; STATIC ELECTRICITY; SUSPENSION; THAWING;

EID: 84855892592     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22815     Document Type: Article

References (7)

1. 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.
2. Clausi A, Cummiskey J, Merkley S, Carpenter JF, Braun LJ, Randolph TW. 2008. Influence of particle size and antigen binding on effectiveness of aluminum salt adjuvants in a model lysozyme vaccine. J Pharm Sci 97(12):5252-5262.
3. 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(1):3-8.
4. 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.
5. 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.
6. User Manual, Micro-Flow Imaging™ (MFI) DPA4100/4200 Flow Microscope MVSS. 2010. Brightwell Technologies Inc., pp 89.
7. Rinella JV, White JL, Hem SL. 1998. Effect of pH on the elution of model antigens from aluminum-containing adjuvants. J Colloid Interface Sci 205:161-165.