VOQUEZNA Tablet Ref.[107221] Active ingredients: Vonoprazan

Vonoprazan (as the fumarate), is a potassium-competitive acid blocker. Chemically, it is 1H-pyrrole-3-methanamine, 5-(2-fluorophenyl)-N-methyl-1-(3-pyridinylsulfonyl)-, (2E)-2-butenedioate (1:1). Its empirical formula is C₁₇H₁₆FN₃O₂S•C₄H₄O₄ with a molecular weight of 461.5.

Vonoprazan fumarate has the following structure:

Vonoprazan fumarate is white to nearly white crystals or crystalline powder which melts at 194.8°C. Vonoprazan fumarate is soluble in dimethyl sulfoxide; sparingly soluble in N,N–dimethylacetamide, slightly soluble in N,N-dimethylformamide, methanol and water; very slightly soluble in ethanol (99.5%); and practically insoluble in 2-propanol, acetone, 1-octanol, and acetonitrile.

VOQUEZNA (vonoprazan) tablets are available in two dosage strengths for oral administration: 10 mg of vonoprazan (equivalent to 13.36 mg of vonoprazan fumarate) and 20 mg of vonoprazan (equivalent to 26.72 mg of vonoprazan fumarate). Each film-coated tablet contains the following inactive ingredients: ascorbic acid, croscarmellose sodium, ferric oxide red (only in 20 mg tablets), ferric oxide yellow (only in 10 mg tablets), fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.