Disintegration performance of renal multivitamin supplements

Abstract

Objective: Vitamins have traditionally been regulated as dietary supplements and have not been required to meet the same rigorous product quality performance standards as drug products. Impaired product performance, such as failure to disintegrate and/or dissolve in the gastrointestinal tract, could limit the absorption of vitamins. Furthermore, patients with renal disease have been reported to experience a wide range in gastrointestinal pH, which could influence a product's performance. The purpose of this study was to determine the effect of pH on the in vitro disintegration of renal multivitamin supplements. Design: Products were studied using the United States Pharmacopeial Convention standard disintegration apparatus. Products were tested in simulated gastric fluid, neutral fluid, and intestinal fluid. Product failure was defined as two or more individual tablets or capsules failing to disintegrate completely within compendial limits. Results: Of 11 products tested, 4 products failed the disintegration study test in all pH conditions. Sixty-four percent of the products showed statistically significant differences in disintegration time (DT) based on pH. As pH increased, time to disintegration increased. Conclusion: The DT of commercially available renal multivitamin supplements was highly variable. Poorest product performance was shown in simulated intestinal fluid. The pH significantly affected in vitro disintegration in greater than half the products tested. How this affects dissolution and in vivo performance has yet to be studied.