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Hi folks - My experience comes mostly from the commercial side of pharma but during the past few years I've been trying more and more to understand manufacturing and regulatory issues.
Does anyone understand manufacturing of high potency compounds? Specifically, I'm looking at an API called estradiol. I know from doing some desk research on my own that there are many generic products out there with the estradiol API and most are in tablet or capsule form. For example, from looking at the FDA's DMF list, I see there is a estradiol valerate, estradiol cypionate, estradiol-3-benzoate, estradiol and many other APIs on this list.
My question is does it take a specific type of estradiol API to formulate a topical such as a cream or will any estradiol API do? Also, from what I've read it seems that manufacturing any form of estradiol may require specialized facilities, equipment and procedures since it is a high potency compound. Does the same hold true for a cream formulation of estradiol? If yes, is there anything unique needed for a cream formulation that is above and beyond what is needed for typical estradiol manufacturing?
Thank you in advance for considering my questions.