Sugar Coating Variation


We have sugar coating process thas is not dissolving in 0.1N HCL for 1 hour. And after added buffer it dissolves in 5 minutes. We want to change this process to film coating or mixed sugar coating process. We tried it with mixed sugar coating process and f2 results are okay.

My question is should we check the f2 value when it is not dissolving in 0.1 N ? or is there specific term. For example 0.1 N it should not dissolve more than 10 percent.

Which way should i follow?

I would suggest, instead of going for mixed sugar coating process, you can go for regular film coating process of tablets. This is to avoid complications in dissolution procedure and it’s acceptance criteria. Generally, it is not advisable to release the batches on F 2 criteria.

If i will continue with regular film coating probaly it should be enteric coating.

Actually my question is about regulatory. What is the rule for enteric coationg dissolution, f2 or anything else?

I suggest better you go for normal film coating . In normal film coating you have lot of options using any of the readymade system, or you may have in -house coating system with weight gain of 1.5 to 2.0 % w/w. Normal fim coating have minimum o hardly any variation, while sugar coating is old technology based on skill of the operator and operating conditions.