Dissolution tester, one of the necessary tools for dissolution testing in the research and development of chemical drugs and the consistency evaluation of generic drugs. A good dissolution tester can make the dissolution test more effective. So how should we choose a dissolution tester for daily use?
According to the 2020 Chinese Pharmacopoeia, we can clearly know: Dissolution testers include conventional dissolution testers, flow cell method dissolution testers, and reciprocating cylinder method dissolution testers. The so-called conventional dissolution tester is the one we mentioned daily. The main dissolution methods include rotating basket method, paddle method, small cup method, paddle-disk method, rotating drum method, which are widely used dissolution equipment. The new flow-through dissolution apparatus and reciprocating cylinder method are all aimed at dissolution experiments under specific conditions. For example, the reciprocating cylinder method can simulate the dissolution test of the human body on an empty stomach. Therefore, when purchasing a dissolution tester, we first need to determine whether to use a conventional dissolution tester or a dissolution tester for specific method.
Secondly, the rotating basket method and the paddle method, as the classic dissolution test methods, are mainly used for ordinary preparations, sustained and controlled release preparations or enteric-coated preparations, and the test operation is simple. The third method, small cup method, as a special method included in the Chinese Pharmacopoeia, is mainly used for tablets whose active drug content is low and cannot meet the requirements of the dissolution value determination by the classic method. The fourth method paddle-disk method and the fifth method rotating drum method are mostly used in trans-dermal patches. Therefore, when choosing a conventional dissolution tester, it is necessary to select a suitable dissolution method kit according to the variety of the preparation.
In addition, due to the different characteristics of the tablets themselves, such as photosensitive tablets, all sources of light in the laboratory must be shut down and blocked when performing dissolution experiments, so it is difficult for us to observe the dissolution of the tablets in the dissolution cup. At this time, if the dissolution tester itself has a red lighting system, it can provide us with a lighting condition under dark conditions. For another example, when we conduct the dissolution experiment of granules, if the dissolution apparatus adopts a horizontal dosing cover design, it is not conducive to ensure that the granules completely enter the dissolution cup, and an additional granule dosing device is required.
Third, the common cup types of conventional dissolution testers on the market are 8 cups and 12 cups (12+2 cups, including 2 isothermal rehydration cups). Generally, we choose 6 tablets as a set of dissolution tests in the experiment. Therefore, the 8-cup dissolution tester, two cups of which can be used as a blank control or as a backup, can even meet the test requirements of isothermal rehydration. With the 12-cup (12+2 cups) dissolution tester, we can perform two sets of dissolution experiments at the same time, which plays a vital role in the comparison of the dissolution curves of generic drugs and original drugs. Therefore, in the preliminary research and development of generic drugs, the workload of exploring the dissolution curve of the original drug is large, and the consistency evaluation experiment of the generic drug is also required. The selection of a 12-cup dissolution tester can reduce the workload of the experimenters and improve work efficiency.
Fourth, with the continuous improvement of laws and regulations, the government
has become more and more strict in drug quality supervision, and the data recording requirements in the dissolution experiment process have become more and more standardized. Therefore, the dissolution tester with user rights management and audit trail functions is now introduced. It can set the user authority of the dissolution apparatus and record the data generated during use in detail for subsequent verification.
Finally, do you have to choose an auto-sampler after choosing a dissolution tester? In the dissolution experiment, when the temperature of the dissolution tester is constant, we will choose synchronous or sequential administration according to the original tablet situation. After synchronous administration, there will inevitably occur when the sampling time is up and synchronous sampling is required. If the experimenter is not skilled in the operation, the error of the dissolution value will inevitably be caused by human factors. In this case, the auto-sampler can avoid this problem. In addition, in the experiment of exploring the dissolution curve, there are many sampling times, and the intelligent dissolution sampling collection system with automatic sampling function can be used to directly sample into the liquid phase injection bottle in order to automatically complete the dissolution experiment, which can greatly reduce the experimental error and labor costs. Therefore, the intelligent dissolution sampling collection system plays an indispensable role in the development and consistency evaluation of generic drugs.