Dissolution sinker or dissolution basket - Dissolution test

Dissolution sinker or dissolution basket?

My first two articles have written some problems encountered during the use of the dissolution sinker. Today, there is a new topic.

Selection of capsule or tablet dissolution test methods.

Dissolution sinker or dissolution basket?

Here is a question from a customer.

“ The reference preparation has been imported in China and has been applied to the Chinese Pharmacopoeia. The dissolution standards of EP, BP, USP and CP are all baskets (100 rpm). The 15 minutes of the four media are more than 85%, and the self-made products are also the same. According to the test results, I can initially determine that the self-made product is similar to the reference preparation.

I am having a problem now.

I inspected the settlement basket method (paddle method 50 revolutions), The conclusion is that the reference preparation and the self-made product are less than 85% in 15 min, and the phenomenon is that the bottom of the particle accumulation vessel is blocked, and the sedimentation basket blocks the particles, resulting in slow dissolution.

From the results, it is necessary to judge whether or not the similarity is obtained by calculating F2, and as a result, F2 is less than 50.

Do I need to consider the settlement basket method to examine the prescription? I plan to choose the basket method to investigate the dissolution, can I? ”

Here are some answers from enthusiastic customers.

“ A dissolution method can be compared. If you consider the consistency of multiple detection methods, the paddle method and the sedimentation basket cannot hinder the dissolution behavior of the sample. If the sedimentation basket has an effect, you can consider replacing the self-made sedimentation wire. It is possible to sink the preparation to the bottom of the cup, which is ok;

There is particle accumulation on the bottom of the cup, and your dissolution method is not suitable. The reason is not necessarily the effect of the complete settling basket. Check the speed and add it to the 75 rpm test.”

“ What is the pharmacokinetic parameter if the absorption rate is faster. It can be completely released and absorbed in the stomach, and the risk is small. It is sufficient to examine the appropriate amount other than the four curves, and it is not necessary to carry out excessively cumbersome research. If not, try increasing the discriminatory conditions for comparison. ”

“1. Each standard uses the basket method for 100 turns(dissolution basket). Have you tried the 75-turn method of the sinker basket method(dissolution sinker), and how is the speed of homemade research release similar?

2. Generally speaking, the basket method is 100 turns and the paddle method is 75 turns, so your paddle method may turn down 50 turns, and the settling basket also blocks the release of particles.

3. “The sedimentation basket blocks the particles, resulting in slower dissolution.” Does this phenomenon occur in the original research? ”

If you have any other questions about the dissolution basket and the dissolution sinker, please leave a message.