6 Dissolution Technologies | NOVEMBER 2013 Investigation of the Disintegration Behavior of Dietary Supplements in Different Beverages Jieyu Zuo, Yuan Gao, May Almukainzi, and Raimar Löbenberg* Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Alberta, Canada, T6G 2E1 ABSTRACT The aims of this study were to assess how different beverages and temperatures impact the disintegration time of commer- cial dietary supplements. Four commercial tablet products, calcium citrate, Ester-C, Boswellia serrata extract, and cinnamon extract, which are considered vitamin–mineral dosage forms or botanical dosage forms, were tested. As described in USP General Chapter <2040> Disintegration and Dissolution of Dietary Supplements, Apparatus A and Apparatus B with or without disks were used with a two-station disintegration tester. Beakers (1000 mL) that met the USP <2040> standards were used, and two temperature conditions were tested: 37 °C and 5 °C. Six different types of beverages, including cola, orange juice, and 5%, 10%, 20%, and 40% alcohol, were compared against water. Boswellia serrata extract failed to disintegrate. With the exception of 5% alcohol, all beverages had a significant effect on the disintegration time of calcium citrate and Ester-C. Only cola, orange juice, and 40% alcohol significantly influenced the disintegration time of the cinnamon extract. The temperature of the immersion media did not affect all of the tested products. The tested beverages should not be used to replace water when ingesting therapeutic products. KEYWORDS: Disintegration, beverage, dietary supplement. INTRODUCTION D isintegration is a prerequisite for dissolution of immediate-release oral dosage forms. The disin- tegration test is often used to determine whether tablets or capsules disintegrate within the desired time when placed into a liquid medium at given experimen- tal conditions (1, 2). This test is a useful tool for quality control and can be a critical parameter for drug release in certain scenarios like highly soluble drugs (3, 4). However, disintegration is not a universal surrogate for dissolution as shown in the 1970s for drugs like digoxin. At that time, disintegration was the only required performance test for oral solid dosage forms. Several studies showed that tablets with similar disintegration times failed bioequiva- lence tests due to different dissolution behaviors of the drug (5, 6). However, these early studies showed the value of disintegration and dissolution testing. Dietary supplements that contain a specific dietary ingredient or ingredients are designed to supplement the diet and enhance nutritional supply. Dietary supplements may include vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tis- sues, glandular tissues, metabolites, or probiotics (7). United States Pharmacopeia (USP) General Chapter <2040> is devoted to dietary supplements, and it divides dietary supplement dosage forms into three categories: vitamin–mineral dosage forms, botanical dosage forms, and other dosage forms (1). The products used in this project included vitamin–mineral dosage forms and botanical dosage forms. The only difference between these two dosage forms is in the use or omission of disks for the disintegration tests (1). Previous studies conducted by Almukainzi et al. (8) and Schmid et al.(9) found that the disintegration time was sensitive to the change of the disintegration apparatus conditions. Both studies contrib- uted to the update of USP General Chapter <2040>. Due to the variety of the excipients and the formulation procedures, different disintegration phenomena may be observed for various dietary supplements. This may lead to differences in the bioavailability of the active ingredi- ents. However, very few comprehensive studies are avail- able that show the bioavailability of dietary supplements linked to the biopharmaceutical properties of the dosage form. From a scientific point of view, it is clear that the contents of a dosage form can dissolve and get absorbed to be bioavailable only if it disintegrates. Therefore, disin- tegration is the most basic step to ensure bioavailability, but as mentioned before, it is not a universal surrogate for bioavailability. It is well established that drugs should be taken with a glass of water, while many dietary supplements do not give any further instructions except for the units per serv- ing. No beverage (e.g., water) is specified, and it can be as- sumed that any available beverage, including pop, juices, and alcoholic beverages, might be used for the adminis- tration of dietary supplement dosage forms. The aim of this study was to investigate the impact of bev- erages, particularly beverages containing different concen- trations of alcohol, on the disintegration time of commercial- ly available dietary supplements and to evaluate the effect of beverage temperature on the disintegration behaviors. MATERIALS AND METHODS Materials This study investigated the influence of beverages on the three commercial tablets: calcium citrate (Kirkland, *Corresponding author. e-mail: raimar.loebenberg@ualberta.ca dx.doi.org/10.14227/DT200413P6