Cialan helps every formulation person to purchase a right dissolution tester.
The way to phase a right dissolution tester for formulation person.
Detection method.
It includes conventional dissolution testers, flow cell dissolution testers, and reciprocating cylinder dissolution testers. The so-called conventional dissolution tester is the dissolution tester we refer to daily. The main dissolution methods include basket method, pulp method, small cup method, pulp disk method, and rotating drum method. It is a widely used dissolution equipment. The newly added flow-through dissolution apparatus and reciprocating cylinder method are both aimed at dissolution experiments under specific conditions. For example, the reciprocating cylinder method can simulate the dissolution test of the human body under fasting conditions. Therefore, when purchasing a dissolution tester, we first need to determine whether to use a conventional dissolution tester or a specific method of dissolution test equipment.
Types and characteristics of preparations.
1.The basket method and the slurry method, as classic dissolution test methods, are mainly used for ordinary preparations, sustained-release preparations or enteric-coated preparations, and the test operation is simple. The small cup method, as a special method included in the Chinese Pharmacopoeia, is mainly used for tablets with low active drug content and the classical method cannot meet the requirements for dissolution value determination. The paddle disc method and the rotating drum method are mostly used for transdermal patches. Therefore, when choosing a conventional dissolution tester, you need to select an appropriate dissolution method kit according to the type of preparation.
2. In addition, due to the different characteristics of the tablets themselves, such as photosensitive tablets, when conducting dissolution experiments, all light sources in the laboratory must be turned off and blocked, making it difficult for us to observe the dissolution of the tablets in the dissolution vessel. At this time, if the dissolution tester itself has a red light illumination system, it can provide us with a light-proof lighting condition. For another example, when we conduct granule dissolution experiments, if the dissolution apparatus adopts a horizontal dosing cover design, it is not conducive to ensuring that the granules completely enter the dissolution cup, and an additional granule dosing device is required.
Quantity requirements for dissolution vessels.
The common cup types of conventional dissolution testers on the market include 8 cups and 12 cups (12+2 cups, including 2 isothermal rehydration cups). Generally, we will choose 6 tablets as a set of dissolution tests in the experiment. . Therefore, in an 8-cup dissolution tester, two of the cups can be used as either a blank control or a backup, even meeting the test requirements for isothermal rehydration. As for the 12-cup (12+2-cup) dissolution tester, all manufacturers adopt a dual-drive and dual-control control method. In other words, with the 12-cup dissolution tester, we can conduct two sets of dissolution experiments at the same time, which plays a vital role in comparing the dissolution curves of generic drugs and original drugs. Therefore, in the early stage of research and development of generic drugs, it is a heavy workload to explore the dissolution curve of the original drug, and also to conduct consistency evaluation experiments of generic drugs. Choosing a 12-cup dissolution tester can reduce the workload of the laboratory personnel and improve the efficiency of the experiment. Work efficiency.
Data record.
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 during dissolution experiments have become more and more standardized. Therefore, now we have launched user rights management and audit tracking functions. dissolution tester. It can set the user permissions of the dissolution apparatus and record the data generated during use in detail for subsequent verification. In recent years, with the widespread application of Internet+, LIMS systems have also become popular, and dissolution testers will eventually be connected to this system. However, the network protocols of the current LIMS system are not unified, and the application of the system is in chaos. In this case, the dissolution tester is only required to have a network port, and the connection with the LIMS can be achieved by upgrading the software version.
Automatic sampling function.
Finally, after choosing a dissolution tester, is it necessary to choose an automatic sampler? In the dissolution experiment, when the temperature of the dissolution tester is constant, we will choose simultaneous dosing or sequential dosing according to the original tablet condition. After synchronous dosing, there will inevitably be situations where synchronous sampling is required when the sampling time is up. If the experimenter is not skilled in the operation, errors in the dissolution value will inevitably be caused by human factors. At this time, the automatic sampler can avoid this problem. In addition, in the experiment of exploring the dissolution curve, the number of samplings is large. An 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 experimental errors. , reduce labor costs. Therefore, the intelligent dissolution sampling collection system plays an indispensable role in the research and development and consistency evaluation of generic drugs.
Summary
Dissolution tester is an essential tool in the work process of every formulation person. cialan is engaged in the research and development of dissolution testers and hope to contribute to the development of dissolution testers.
Detection method.
It includes conventional dissolution testers, flow cell dissolution testers, and reciprocating cylinder dissolution testers. The so-called conventional dissolution tester is the dissolution tester we refer to daily. The main dissolution methods include basket method, pulp method, small cup method, pulp disk method, and rotating drum method. It is a widely used dissolution equipment. The newly added flow-through dissolution apparatus and reciprocating cylinder method are both aimed at dissolution experiments under specific conditions. For example, the reciprocating cylinder method can simulate the dissolution test of the human body under fasting conditions. Therefore, when purchasing a dissolution tester, we first need to determine whether to use a conventional dissolution tester or a specific method of dissolution test equipment.
Types and characteristics of preparations.
1.The basket method and the slurry method, as classic dissolution test methods, are mainly used for ordinary preparations, sustained-release preparations or enteric-coated preparations, and the test operation is simple. The small cup method, as a special method included in the Chinese Pharmacopoeia, is mainly used for tablets with low active drug content and the classical method cannot meet the requirements for dissolution value determination. The paddle disc method and the rotating drum method are mostly used for transdermal patches. Therefore, when choosing a conventional dissolution tester, you need to select an appropriate dissolution method kit according to the type of preparation.
2. In addition, due to the different characteristics of the tablets themselves, such as photosensitive tablets, when conducting dissolution experiments, all light sources in the laboratory must be turned off and blocked, making it difficult for us to observe the dissolution of the tablets in the dissolution vessel. At this time, if the dissolution tester itself has a red light illumination system, it can provide us with a light-proof lighting condition. For another example, when we conduct granule dissolution experiments, if the dissolution apparatus adopts a horizontal dosing cover design, it is not conducive to ensuring that the granules completely enter the dissolution cup, and an additional granule dosing device is required.
Quantity requirements for dissolution vessels.
The common cup types of conventional dissolution testers on the market include 8 cups and 12 cups (12+2 cups, including 2 isothermal rehydration cups). Generally, we will choose 6 tablets as a set of dissolution tests in the experiment. . Therefore, in an 8-cup dissolution tester, two of the cups can be used as either a blank control or a backup, even meeting the test requirements for isothermal rehydration. As for the 12-cup (12+2-cup) dissolution tester, all manufacturers adopt a dual-drive and dual-control control method. In other words, with the 12-cup dissolution tester, we can conduct two sets of dissolution experiments at the same time, which plays a vital role in comparing the dissolution curves of generic drugs and original drugs. Therefore, in the early stage of research and development of generic drugs, it is a heavy workload to explore the dissolution curve of the original drug, and also to conduct consistency evaluation experiments of generic drugs. Choosing a 12-cup dissolution tester can reduce the workload of the laboratory personnel and improve the efficiency of the experiment. Work efficiency.
Data record.
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 during dissolution experiments have become more and more standardized. Therefore, now we have launched user rights management and audit tracking functions. dissolution tester. It can set the user permissions of the dissolution apparatus and record the data generated during use in detail for subsequent verification. In recent years, with the widespread application of Internet+, LIMS systems have also become popular, and dissolution testers will eventually be connected to this system. However, the network protocols of the current LIMS system are not unified, and the application of the system is in chaos. In this case, the dissolution tester is only required to have a network port, and the connection with the LIMS can be achieved by upgrading the software version.
Automatic sampling function.
Finally, after choosing a dissolution tester, is it necessary to choose an automatic sampler? In the dissolution experiment, when the temperature of the dissolution tester is constant, we will choose simultaneous dosing or sequential dosing according to the original tablet condition. After synchronous dosing, there will inevitably be situations where synchronous sampling is required when the sampling time is up. If the experimenter is not skilled in the operation, errors in the dissolution value will inevitably be caused by human factors. At this time, the automatic sampler can avoid this problem. In addition, in the experiment of exploring the dissolution curve, the number of samplings is large. An 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 experimental errors. , reduce labor costs. Therefore, the intelligent dissolution sampling collection system plays an indispensable role in the research and development and consistency evaluation of generic drugs.
Summary
Dissolution tester is an essential tool in the work process of every formulation person. cialan is engaged in the research and development of dissolution testers and hope to contribute to the development of dissolution testers.
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