Avandia Ingredients and Composition
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Avandia Ingredients and Composition
Chemically, Avandia's active substance, rosiglitazone maleate is (±)-5-[[4-[2-(methyl-2-pyridinylamino)ethoxy]phenyl]methyl]- 2,4-thiazolidinedione,(Z)-2-butenedioate (1:1) with a molecular weight of 473.52 (357.44 free base). The molecule has a single chiral center and is present as a racemate. Due to rapid interconversion, the enantiomers are functionally indistinguishable.
The molecular formula is C18H19N3O3S•C4H4O4. Rosiglitazone maleate is a white to off- white solid with a melting point range of 122o to 123o C. The pKa values of rosiglitazone maleate are 6.8 and 6.1. It is readily soluble in ethanol and a buffered aqueous solution with pH of 2.3; solubility decreases with increasing pH in the physiological range.
Each pentagonal film-coated Avandia tablet contains rosiglitazone maleate equivalent to rosiglitazone, 2 mg, 4 mg, or 8 mg, for oral administration.
Inactive Avandia ingredients are:
- hydroxypropyl methylcellulose
- lactose monohydrate
- magnesium stearate
- microcrystalline cellulose
- polyethylene glycol 3000
- sodium starch glycolate
- titanium dioxide
- triacetin
- and one or more of the following: synthetic red, yellow iron oxides, talc
