Bioequivalence and Bioavailability Forum

❝ I only ever heard of generic companies going for anther crystal morph when they had to work around an IP issue. Noone that I have ever met would ever accept it for any other reason.

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❝ ❝ Any suggestions???

Hello Mr.El maestro,

Thanks for your response.

You are right, I have to use alternate polymorphic form of API to circumvent the patent claim of the reference product.

The API in the generic product dissolves insanely fast due to highly soluble polymorphic form when it comes in contact with the solvent.

We should decrease the interaction with solvent, that's why I have mentioned in my above post about premix consisting of API and low soluble excipient.

Actually my core question is what are the excipient which can decrease solubility of API when it comes in contact with solvent, in order to match the dissolution profile with low soluble polymorphic form of drug in the reference product.

Can you suggest some excipients or any patent links which can solve the above situation to match dissolution profile with that of reference product.

Thanks and regards,
Hari Kiran.

❝ Try and look up, if you can, Potassium Chloride SR in EU. The API is othwerwise dissolving insanely fast. It's one of them resin-wax-oral-semi-solid-rubber-sponge thingies. I do apologise if that is not exactly what the formulation principle is actually called but I feel I am pretty close.

❝ If I got it right the dissolution in that ...errrmmm... thing... is controlled simply by exposing some but very little API to the solvent at any and all times.