The thing is to prove the pharmaceutical equivalence of the substances mentioned above. All related patents and articles, where the rightfullness of pure, i.e. non-hydrated, substance in the finished dosage form has been shown, are required.
I'll be very thankful for your advice and help.
1) gamma-butyrobetaine is not meldonium: if I read the structures correctly, meldonium has an NH group where the former has a CH2 group, adjacent to the terminal N(CH3)3 group. 2) Hydrated forms of drugs will act identically once they are absorbed into the bloodstream. However, the speed of solution, and hence rate of absorption, of anhydrous materials may be substantially greater than that of hydrates (the heat of hydration helps drive the dissolution). Additionally, anhydrous forms may be more stable in formulations. So no, you cannot deem them equivalent, without demonstrating this (in vivo AND in vitro, because the controlling agencies will want both kinds of data for an application, and the latter data for ongoing quality control batch testing).
OK. you see, midronate (meldonium) and its hydrated form are characterized by respective CAS #-s. Additionally, both ones are categorized as equal pharmaceutical substances - there is a proof at the attached link. But unhydrated meldonium's highly hygroscopic. Thus, acc. to the GMP it can't be used as a substance to produce the finished dosage form (capsules). But this trouble can be avoided via addition of corresponding adjuvants. Furthermore, the primary package (Al-blister card) prevents absorption of water. The trouble is to argue the equality of these pharmaceutical compounds in terms of (non)-hydrated forms. I'll be glad to see opinions of experts having to do with pharmaceutics. Deep scientific disscussions are not required :-)
Anyway, all opinions are useful!
http://www.chemicalbook.com/Search_EN.aspx?keyword=Mildronate
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