Investigation of vitamin and mineral tablets and capsules on the Canadian market.
OBJECTIVE
The goal of this study was to investigate the disintegrating properties of tablets and capsules containing minerals and vitamins commercially available on the Canadian market and to review their label information.


METHODS
The labels were examined for product-related information. The first disintegration test stage was performed using Simulated Intestinal Fluid (SIF) pH 6.8 for 20 minutes. Products which did not disintegrate were further investigated using USP disintegration conditions for dietary supplements.


RESULTS
The provided label information is difficult to understand and in some cases pseudo-scientific. Thirty out of thirty-nine tablets and six out of ten capsules had a Drug Identification Number (DIN). Twenty-one of thirty-nine tablets and four out of the ten capsules did not disintegrate within 20 minutes. Using the USP disintegration conditions for dietary supplements nine tablet products did not fully disintegrate but all capsules passed the test. None of the three "time-released" products disintegrated under the applied conditions.


CONCLUSIONS
Industry should follow already existing label recommendations more closely to allow the consumers to make an informed decision on their products by providing only essential information rather than using pseudo-scientific terms. The results of the disintegration study indicated that disintegration, one of the most basic quality control parameters, is still a concern for dietary supplements.
Löbenberg
Raimar
R
Faculty of Pharmacy, University of Alberta, Edmonton, Alberta, Canada. rloebenberg@pharmacy.ualberta.ca
Steinke
Wayne
W
D002170:Canada; D002214:Capsules / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D004348:Drug Labeling; D008903:Minerals / Q000737:chemistry; D004366:Nonprescription Drugs / Q000737:chemistry*; D011786:Quality Control; D013607:Tablets / Q000737:chemistry*; D024505:Tocopherols / Q000737:chemistry; D014815:Vitamins / Q000737:chemistry
D002214:Capsules; D008903:Minerals; D004366:Nonprescription Drugs; D013607:Tablets; D014815:Vitamins; D024505:Tocopherols