E-DRUG: FDC of Artesunate and Amodiaquine
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Dear e-drugers,
I am currently working on a fixed dose combination of artesunate and amodiaquine hydrochloride (100/400). I have developed a formulation which has given recoveries of over 98% of both APIs after 12 months, but I still get remarks from colleagues to the effect that the two are incompatible, with references to some well-established pharmaceutical companies' inability to have such a formulation in the market.
I also have looked at the dissolution profiles of the formulation and I am quite encouraged by the results.
However, these remarks make me wonder if there are some issues outside of stability/compatibility and, dissolution; which will have bearing on the pharmacokinetics that should be considered.
I will appreciate your comments.
Thank you.
Ndimele Leo Ugochukwu
ndimele_leougoch@excite.com
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