Orfadin® capsules contain Nitisinone, which is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase used in the treatment of hereditary tyrosinemia type 1 (HT-1).

Nitisinone occurs as white to yellowish-white, crystalline powder. It is practically insoluble in water, soluble in 2M sodium hydroxide and in methanol, and sparingly soluble in alcohol.

Chemically, Nitisinone is 2-(2-nitro-4-trifluoromethylbenzoyl) cyclohexane-1,3-dioneand the structural formula is:

The molecular formula is C₁₄H₁₀F₃NO₅ with a relative mass of 329.23

Orfadin® is a hard white-opaque capsule, marked as 2 mg, 5 mg or 10 mg strengths of Nitisinone and is intended for oral administration. Each capsule contains 2 mg, 5 mg or 10 mg Nitisinone, plus pregelatinized starch. The capsule shell is gelatin and titanium dioxide and the imprint is an iron oxide.

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