SPL Set ID: dc5e4875-fcd7-408c-88c9-4a715f4384b6
1 drug(s) with this SPL Set ID
Nitisinone capsules contain nitisinone, which is a 4-hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to yellowish-white, crystalline powder. It is Freely soluble in Acetone, Ethyl acetate and Methylene chloride. Sparingly soluble in absolute alcohol and practically insoluble in water Chemically, nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl)- 1,3-cyclohexanedione, and the structural formula is: Figure 1. The molecular formula is C14H10F3NO5 with a relative mass of 329.23 Capsules: Hard, white-opaque capsule, 2 mg, 5 mg, 10 mg, and 20 mg strengths of nitisinone, intended for oral administration. Each capsule contains 2 mg, 5 mg, 10 mg, or 20 mg nitisinone, anhydrous lactose and stearic acid. The capsule shell contains gelatin and titanium dioxide, and the imprinting ink contains black iron oxide, propylene glycol, potassium hydroxide, shellac, and strong ammonia solution. Structural Formula