Comparison of the adjuvanticity of aluminum salts and their combination in hepatitis B recombinant protein vaccine in assessed mice

Several adjuvants have been evaluated for vaccine formulations but aluminum salts will continue to be used for many years due to their safety, low cost and adjuvanticity with different antigens. Two commonly used aluminum adjuvants, aluminum hydroxide and aluminum phosphate have different adjuvanticity properties. Commercial recombinant protein hepatitis B vaccines containing aluminum hydroxide is facing low induction of immunity in some sections of the vaccinated population. In this study, to follow the current global efforts in finding more potent hepatitis B vaccine formulations, adjuvanticity of aluminum phosphate, aluminum hydroxide and their combinations has been evaluated. The formulated vaccines were administered intra-peritoneally [i.p.] to BALB/c mice and the titer of antibody was determined after 28 days using ELISA technique. The geometric mean of antibody titer [GMT, mIU/ml], seroconversion and seroprotection rates, ED50 [ng] and relative potency [micro g/dose] of different formulations were determined. GMT of antibody titer, seroconversion and seroprotection rates showed significantly higher adjuvanticity for aluminum phosphate than other formulations. The ED50 of aluminum phosphate was approximately two fold less than other formulations. Aluminum phosphate showed more adjuvanticity than aluminum hydroxide and their combinations in hepatitis B protein vaccine. The use of aluminum phosphate as adjuvant leads to higher immunity which may result in more protective response in vaccinated groups

Assessment of different bioequivalence metrics in rifampin bioequivalence study

The use of secondary metrics has become special interest in bioequivalency studies. The applicability of partial area method, truncated AUC and Cmax/AUC has been argued by many authors. This study aims to evaluate the possible superiority of these metrics to primary metrics [i.e. AUCinf, Cmax and Tmax]. The suitability of truncated AUC for assessment of absorption extent as well as Cmax/AUC and partial AUC for the evaluation of absorption rate in bioequivalency determination was investigated following administration of same product as test and reference to 7 healthy volunteers. Among the pharmacokinetic parameters obtained, Cmax/AUCinf was a better indicator or absorption rate and the AUCinf was more sensitive than truncated AUC in evaluation of absorption extent