Apparatus 3 for hard gelatine capsule (in vitro)

Question

Hi all!
Mayde some of you can help me.
We are going to develop solid dosage form with immediate release (hard gelatine capsule).
We have to use Apparatus 3 for routine Dissolution (to overcome problem with crosslinking of gelatine) and also for in vitro study.
Has anyone had the same experience?
What documents are regulating the current requirements?

kenboda · Answer

Hello, the use of Apparatus 3 has been recommended and used for hard gelatin capsules and several other formulations. It does allow for higher shear forces which can be helpful to overcome mild cross-linking. It also has the benefit of being able to limit enzyme use to the 1st row in order to have fewer filtration issues, etc. in subsequent rows. Apparatus 1 and 2 are still the most common way to test these products though. Another possible consideration is the stationary basket over paddle method which is now mentioned in USP <711>. This approach also has much higher shear forces than a traditional Apparatus 1 and 2 system.

Apparatus 3 for hard gelatine capsule (in vitro)

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