Consumer vinegar test for determining calcium disintegration.
A consumer test and standardized methods were compared for measuring the disintegration of calcium tablets, and the disintegration results were compared with results of dissolution testing to determine the ability of the consumer test of disintegration to predict bioavailability of calcium. Disintegration of 17 calcium supplement products, in tablet form, was studied in Simulated Gastric Fluid Test Solution, USP, without pepsin (GF), in distilled water, and in white distilled vinegar. For disintegration testing with GF and with distilled water, six tablets of each product were placed in an apparatus and immersed in the solution at 37 degrees C for 60 minutes. Six tablets of each product were tested in 200 mL of vinegar at room temperature for 30 minutes. Disintegration was determined by visual observation. Seven products were tested for dissolution in GF or water. Three samples of each product were tested at intervals over 120 minutes for calcium content. Results of testing with an ion-selective electrode were converted to milligrams and compared with the calcium content of the tablets (as claimed on the package label). The mean disintegration times of various calcium products in vinegar ranged from 1.8 to greater than 30 minutes. The mean time in distilled water and GF ranged from 1.6 to greater than 60 minutes and from 1.0 to greater than 60 minutes, respectively. Results were in agreement in 87% to 93% of cases between the consumer vinegar test and the standardized disintegration test methods, a significant correlation. No correlation was found between disintegration time and the extent of dissolution. The disintegration and dissolution of commercially available calcium tablets was highly variable.(ABSTRACT TRUNCATED AT 250 WORDS)
Mason
N A
NA
College of Pharmacy, University of Michigan, Ann Arbor 48109-1065.
Patel
J D
JD
Dressman
J B
JB
Shimp
L A
LA
D000085:Acetates / Q000737:chemistry*; D019342:Acetic Acid; D002118:Calcium / Q000737:chemistry*; D002119:Calcium Carbonate / Q000737:chemistry; D002125:Calcium Gluconate / Q000737:chemistry; D002130:Calcium Phosphates / Q000737:chemistry; D002951:Citrates / Q000737:chemistry; D019343:Citric Acid; D006801:Humans; D012995:Solubility; D013607:Tablets / Q000737:chemistry; D013997:Time Factors; D014867:Water
D000085:Acetates; D002130:Calcium Phosphates; D002951:Citrates; D013607:Tablets; C485828:alpha-tricalcium phosphate; C485830:tetracalcium phosphate; D014867:Water; D019343:Citric Acid; C485838:calcium phosphate, monobasic, anhydrous; C020243:calcium phosphate; D002119:Calcium Carbonate; C485829:calcium phosphate, dibasic, anhydrous; D019342:Acetic Acid; D002125:Calcium Gluconate; D002118:Calcium