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Dissolution sinker and dissolution test of granular drugs

Dec. 06, 2018

I mentioned in the last blog a question that a customer has in using the dissolution sinker. I found that I missed a problem.

Some customers have discussed with us a question, whether the granular drug needs to be tested for dissolution.

 

This topic starts with a customer's question:

1. Does the granule drug need to be tested for dissolution?

2.  If you need to do a dissolution test, how to use the dissolution sinker ?
Because the size of the particles is too small to fit in the settling basket, there is no way to prevent the particles from falling out of the pore size of the dissolution sinker.

 

The enthusiastic customer who answered the previous question gave us the answer.

 

Here is his original words:

“For me, the dissolution of granules is unheard of, but it also gives me a long-term insight. I don't know why the granules do not dissolve.

Granular drugs do not use a dissolution sinker, but this does not mean that the granular drug does not need to be tested for dissolution.”

 

In addition, he also added the previous question.

 

“The premise of in vitro release of the preparation is that it can simulate the release in vivo. If you can't meet the requirements without adding a settling basket, you can pass the test.

There must be at least one method that is not consistent with the release in the body.

Simply put, the method you choose should be as consistent as possible in the body.

In view of the special circumstances of controlled release preparations, the country does not have uniform control standards.

If you are a Class 1 new drug, you must compare the in vivo and in vitro. If the imitation can be compared with the foreign marketed samples, whether the release curves are different in the two cases, and which conditions are better for different formulations. It can be used in formulation prescription research and quality control.”

 

I am very grateful to this enthusiastic customer, I have an idea. I have established a discussion group, everyone can communicate together, you can discuss problems when you encounter problems, if you are interested, you can leave a message.

 

About the dissolution sinker, interested can add my Skype: queen.oliveer.


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