Comparison of Dissolution Profiles for Albendazole Tablets Using USP Apparatus 2 and 4

Abstract

The in vitro dissolution of albendazole from three different commercially available products (200 mg tablets) was studied using U.S. Pharmacopeia (USP) Apparatus 2 and USP Apparatus 4 in order to compare the release performance of the drug in two essentially different dissolution systems. For both cases, 0.1 N HCl was used as dissolution medium. Only the reference product and one of the generic products studied met the 80% USP 24 specification for albendazole dissolved at 30 min, using USP Apparatus 2. Although the reference product reached 80% of albendazole dissolved at 30 min when Apparatus 4 was used, the generic products' dissolution performance was markedly reduced in this system. Though dissolution rate was slower using Apparatus 4, the total quantity of albendazole dissolved from the reference product, represented by area under the dissolution profile, was practically the same regardless of the system used. Dissolution kinetics of albendazole was adequately described by Weibull's function for all the products. The dissolution time (t(d)) derived from data fitting to this function showed significant differences among the products studied. Data analysis based on analysis of variance (ANOVA) showed nonequivalence among the dissolution profiles of generic products compared with the reference product either with the dissolution vessel system or the flow-through cell, as well as nonequivalence among the dissolution profiles using both apparatuses with the same product. Though differences in the dissolution profiles for generic products against the reference product in both systems were found, USP Apparatus 4 showed higher discriminative capacity in differentiating the release characteristics of the products tested.

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

“…2 clarified that USP apparatus IV was the dissolution apparatus that revealed the highest sensitivity and discriminative capability in differentiating between the dissolution behavior of MH products than USP apparatus II and beaker method. Similar observations were reported by Hurtado y de la Peña et al [43] who highlighted by statistical analysis the discriminative capability of USP apparatus IV versus USP apparatus II in differentiating the release characteristics of tested albendazole products. Fig.…”

“…Likewise, other researchers faced such out of limits results. For example, Hurtado y de la Peña et al [43] reported that for different marketed albendazole products, only the reference product and one of the generic products studied met the USP specifications. Moreover, Emara et al [18] presented two commercial products of gliclazide that failed to meet the requirements described by the British Pharmacopoeia.…”

Hydrodynamic and Species Transfer Simulations in the USP 4 Dissolution Apparatus: Considerations for Dissolution in a Low Velocity Pulsing Flow

“…Dissolution rates from a flow-through apparatus have previously been investigated in relation to flow rates (1)(2)(3)(4)(5)(6)(7)(8)(9). Comparisons have also been made between dissolution rates in the paddle apparatus and the flow-through apparatus (3,7,8,10). Suggested flow rates in the flow-through dissolution apparatus (USP apparatus 4 (Flow-Through Cell)) are 4 to 16 ml min −1 (11), although higher flow rates can be, and have been, used (4).…”

Comparison of Generic Furosemide Products by In Vitro Release Studies using USP Apparatus 2 and 4

“…Working with an unlimited amount of solvent is possible, thus overcoming problems due to nonsink conditions. 4. pH changes may be easily performed stepwise since the medium is exchanged very rapidly in the low volume cells (this allows adaptation of test parameters to physiological conditions).…”

“…USP Apparatus 4 has been useful in developing more discriminative dissolution methods than those that employ apparatus 1 or 2, as was demonstrated with commercial tablets of albendazole and carbamazepine, both having low solubility (4,5). Despite the advantages of apparatus 4 over the basket and paddle equipment, little information is available on its application in the evaluation of generic drug products with solubility problems.…”