A Standardized Mini Paddle Apparatus as an Alternative to the Standard Paddle

Abstract

Results from the present series of tests indicate that the mini paddle apparatus is a useful tool in characterizing drug release profiles under “standard test conditions”. Due to the possibility of using smaller sample sizes and smaller volumes of media, it offers various advantages in terms of substance, analytical, and material cost savings when evaluating release properties of drug candidates. The mini paddle setup is also a promising alternative if the analytics are not very sensitive or in the case of highly potent drugs. Because the size and shape of dosage forms can also impact drug release, the mini paddle should preferably be used for powders, multiparticulate dosage forms, and small tablets or capsules (i.e., where the paddle apparatus would be the usual method of choice). Nowadays, there are various types of mini paddle systems available on the market. However, most of these systems reflect everything but a miniaturized reproduction of the USP paddle system. For this reason, the outcome of the present study should not be generalized since changing the dimensions of the setup can quickly result in alterations of the hydrodynamics which, as has been shown in the present study, can have a huge impact on drug release from the dosage form tested. The next steps would be therefore to check, if it is possible to further downsize the setup with maintaining the significance of the compendial setup, to determine the impact of experimental settings on drug release from MR formulations and to measure/simulate flow velocities in the mini vessel.