Scientific Publications by FDA Staff
J Pharm Sci 2013 Apr;102(4):1370-81
Comparative evaluation of the in vitro efficacy of lanthanum carbonate chewable tablets.
Yang Y, Bykadi S, Carlin AS, Shah RB, Yu LX, Khan MA
The aims of this study were to systematically evaluate the effects of pH levels, phosphate concentrations, and tablet integrity on the phosphate binding profiles of lanthanum carbonate chewable tablets, and to compare the in vitro phosphate binding efficacy of one reference and two test products of lanthanum carbonate chewable tablets. Langmuir equation was utilized to calculate the binding constants k(1) and k(2) . The phosphate binding to the tablets of lanthanum carbonate product was pH dependent, with a faster binding rate at low pH. The crushed tablets bind phosphate more rapid. Compared with the whole tablets, the kinetic binding profiles from the crushed tablets were less variable under all conditions for both test and reference products. The phosphate level has a significant impact on the phosphate binding for both whole and crushed tablets under all pH conditions, with more binding at higher phosphate concentration. The phosphate binding profiles displayed significant difference among the products. For a crushed tablet, the phosphate binding to lanthanum reached equilibrium within 8 h under all conditions. The 90% confidence interval for the k(2) ratio (test/reference) was well within the 80%-125% under all pH conditions. However, the k(1) ratio varies from 54% to 144%.
|Category: Journal Article|
|PubMed ID: #23334989||DOI: 10.1002/jps.23454|
|Includes FDA Authors from Scientific Area(s): Drugs|
|Entry Created: 2013-01-22||Entry Last Modified: 2016-03-21|