Dissolution test of generic drug

ASK （questions from customers）

At present, a generic drug is being developed, and the reference standards are only USP and import registration standards.

USP standard: propeller method 50rpm (with spiral dissolution sinker). 

Import registration standard: paddle method 50rpm (without adding dissolution sinker). The remaining parameters are the same as USP.

Specification: 600mg, tablet weight: 1.2g, coating: obadaihuang.

Question:

(1) In the dissolution test, it was found that the tablets were easy to stick to the wall of the dissolution cup after dropping (without dissolution sinker), and the dropping positions were different, some were in the middle of the bottom, and some were stuck to the side of the dissolution cup.
The RSD% of the results is very large.

(2) After adding the standard dissolution sinker (commonly used in China), the sample falls in the middle of the bottom of the dissolution cup.
The problem is: after the disintegration of tablets, the pile is relatively large, and this kind of settling basket lattice is relatively dense. After pressing on the pile, when the paddle stirs, the particles will hardly move, and the dissolution result is small. Take out the basket, and after a few minutes, the dissolution is complete.

(3) After the self-made spiralbasket (the appearance is similar to the elongated spring), the dissolution phenomenon is normal, and the RSD% of the results also meets the requirements.

At present, how to choose. I hope teachers can give some suggestions, thank you.

Reply

USP is the main choice, and it is suggested to choose (3).

Only by choosing the right basket can we truly reflect the product quality.