The study investigated the influence of beaker size, apparatus, use of disks (when appropriate), and the nature of the immersion medium on the disintegration time of tablets and capsules. The disintegration times were determined for seven commercial tablets and capsule products. Boswellia serrata (The Vitamin Shoppe, Lot# 082658, exp 09/11), Cinnamon (The Vitamin Shoppe, Lot# 2036475, exp 08/12), Ester-C (American Health, Lot# 234536-07, exp 08/10), Oyestercal (Puritan's Pride, Lot# 415720-10, exp 03/12) and glucosamine Move Free (Schiff, Lot# S2438D4, exp 08/10) were the tablet formulations and Chasteberry (Solaray, Lot# 93409850807, exp 10/11), and Zinc (The Vitamin Shoppe, Lot# 083332, exp 07/11) were capsules products, which were investigated.
A disintegration tester (model ED-2 L, Electrolab, Betatek Ontario) consisted of two stations; each was used with Apparatus A USP chapter <701> or Apparatus B as described in USP chapter <2040>. The small beaker (SB) had a nominal volume of 1,000 mL with an inside diameter of 101
1 mm and the large beaker (LB) had a nominal volume of 1, 500 mL and an inside diameter of 114
Four different equipment configurations and two beaker sizes resulting in eight test conditions were investigated: An SB and USP Apparatus A (App A) with disk, SB App A without disk, SB USP Apparatus B (App B) with disk, SB beaker apparatus App B without disk, LB App A with disk, LB App A without disk, LB App B with disk and LB App B without disk. The tests were performed with 18 test units and the media employed for this study was water for all tests.
All the equipment and beaker sizes investigated for tablets were also applied to Chasteberry capsules. In addition, this study included the evaluation of three different media: water, USP buffer pH4.5, and USP simulated gastric fluid (SGF) (n
The Zinc capsules did not disintegrate within 90 min. Therefore, no investigation was performed without disks for this product. The disintegration time determinations were performed using SB App A, SB App B, LB App A and LB App B, all with disk. Due to the cellulose nature (HPMC) of their hard shell body, five different media were tested in this study: water, USP buffer pH4.5, USP SGF, USP simulated intestinal fluid (SIF) a potassium–phosphate-based buffer and buffer pH 6.8 using sodium–phosphate (n
In all cases the disintegration time was recorded as an independent variable. Next, statistical analysis was performed using two different statistics programs: Minitab 15 (MINITAB Inc.) and SPSS 17 (Statistics Grad Pack). The mean and standard deviation was calculated for all tablets and capsules. The data were analyzed using the two-way ANOVA for the following factors: beaker size (small and big) and equipment (App A with disk, App A without disk, App B with disk, App B without disk). Any value exceeding the critical value of 0.05 indicates no statistical significance. For both tablets and capsules, the ANOVA analysis was repeated using only two factors (beaker size and apparatus). The aim was to investigate the impact of the apparatus and beaker size on the performance of the disintegration test. For capsules, a further ANOVA was performed for each equipment configuration using immersion media as a factor. For Zinc capsules, the impact of the beaker size and apparatus on the performance of the disintegration test was investigated using disks only because the capsules did not disintegrate without disks. Tukey's test was then applied to specify which media exactly caused a statistical impact. To be able to apply ANOVA the test data must meet certain assumptions: The sample populations must be normally or approximately normally distributed. Also, the samples must be independent. Moreover, the variances of the population must be equal; this criterion was checked using Leven's (any continuous distribution) and Bartlett test (normal distribution).