Investigation of the Sedimentation Behavior of Aluminum Phosphate: Influence of pH, Ionic Strength, and Model Antigens

Journal of Pharmaceutical Sciences
Kevin MuthuraniaSatoshi Ohtake

Abstract

Evaluation of the physical characteristics of vaccines formulated in the presence of adjuvants, such as aluminum salts (Alum), is an important step in the development of vaccines. Depending on the formulation conditions and the associated electrostatic interactions of the adjuvant particles, the vaccine suspension may transition between flocculated and deflocculated states. The impact of practical formulation parameters, including pH, ionic strength, and the presence of model antigens, has been correlated to the sedimentation behavior of aluminum phosphate suspensions. A novel approach for the characterization of suspension properties of Alum has been developed to predict the flocculated state of the system using a sedimentation analysis-based tool (Turbiscan®). Two sedimentation parameters, the settling onset time (Sonset) and the sedimentation volume ratio (SVR) can be determined simultaneously in a single measurement. The results demonstrate the suspension characteristics to be significantly altered by solution conditions (pH and ionic strength) and the charge state of bound antigens. Formulation conditions that promote the flocculated state of the suspension are characterized by faster Sonset and higher SVR, and are general...Continue Reading

References

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Citations

May 5, 2017·The Journal of Pharmacy and Pharmacology·Claudia MuellerSilke Mohl
May 4, 2017·Journal of Pharmaceutical Sciences·Lavinia M LewisShellie Rigby-Singleton
Sep 6, 2020·Magnetic Resonance in Chemistry : MRC·Marc B Taraban, Yihua Bruce Yu
Jan 14, 2020·Journal of Pharmaceutical Sciences·Alex LangfordSatoshi Ohtake

Related Concepts

Phosphalugel
Aluminum hydrogen sulfate
Alum Compounds
Metazoa
Antigens
Bos indicus
Flocculation
Hydrogen-Ion Concentration
Leftose
Osmolality

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