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J Pharm Sci. 2013 Apr;102(4):1370-81. doi: 10.1002/jps.23454. Epub 2013 Jan 18.

Comparative evaluation of the in vitro efficacy of lanthanum carbonate chewable tablets.

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1
Division of Product Quality Research, Office of Pharmaceutical Science, Food and Drug Administration, Silver Spring, Maryland 20993, USA. yongsheng.yang@fda.hhs.gov

Abstract

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 k1 and k2 . 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 k2 ratio (test/reference) was well within the 80%-125% under all pH conditions. However, the k1 ratio varies from 54% to 144%. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 102:1370-1381, 2013.

PMID:
23334989
DOI:
10.1002/jps.23454
[Indexed for MEDLINE]
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