Guidelines and their violations

[amol]

Can anybody help me out?

Usually the pharmacopoiea (USP, BP) gives us general guidelines about dissolution, wherein it says that normally for capsules one should use baskets (USP appratus I) and 100 RPM and for tablets one should use paddles (USP appratus II) and 50 or 75 RPM. But can anybody tell me is there any regulatory control on this? OR Can I have a documented evidence saying that the above guidelines are strictly to be followed? What if anybody uses a method at 100 RPM for tablets?
I know all these dissolution parameters depend on the drug, its solubility, its dosage form, the type (i.e. ER, SR etc). But still if anybody violates these guidelines, can any regulatory body catch hold of him?

Please help.... :confused:
Amol

[johnt]

The USP Criteria are guidelines only. When you develop a dissolution method for IND/NDA submission a justification for dissolution media and test parameters is submitted. If you determine for an individual product that 50 rpm baskets or 100 rpm paddles is the ideal conditions than that is what you use.

[syx]

Mr. John,
In other words, we may use 100 rpm paddles?
I have a method for allylestrenol tablet that use this velocity with paddles, in 500 ml medium which contains 0.1N HCl and 0.09% SLS.
This time I want to repair the method with 75 rpm paddles and 900 ml the same medium. If we can use 100 rpm paddles, i think i do not need to repair my method 'cause it just wasting time.
I want the reference(s) about 100 rpm paddles permittion in dissolution testing.

[johnt]

There is no reference I can give you stating that 100rpm paddles is acceptable. This has to come out of a justification for using this parameter. I can only tell you that I have done testing on product using these conditions. I have not heard of this product and it does not appear in the current USP. If this is your in house product the method criteria you have mentioned is acceptable as long as the documentation is there supporting these criteria.

[harthur]

Syx - I agree with John. If you have method development results for your product that support the use of those parameters and then validate your dissolution method, you should be able to defend your method to any regulatory agency. Personally, I have used paddles on capsule formulations and speeds for both paddles and baskets that differ from those suggested in the USP.