Pharmaceutical composition
The present invention relates to oral pharmaceutical compositions comprising nitisinone, or a pharmaceutically acceptable salt thereof, their use in the treatment of tyrosinemia, such as Hereditary Tyrosinemia type-1 (HT-1), or alkaptonuria. The compositions have improved stability characteristics. The invention also relates to processes for producing nitisinone.
1. A pharmaceutical composition suitable for oral administration, consisting of nitisinone, lactose, and glyceryl dibehenate.
2. A pharmaceutical composition according to claim 1 in the form of a compressed tablet.
3. The pharmaceutical composition according to claim 1 , wherein the composition is in the form of a compressed tablet.
4. The pharmaceutical composition according to claim 1 , wherein the composition has an impurity stability of up to 0.5% impurity as measured by HPLC under ICH guidelines of at least 2 months at room temperature.
5. The pharmaceutical composition of claim 4 , wherein the composition has an impurity stability of up to 0.2% impurity as measured by HPLC under ICH guidelines of at least 2 months at room temperature.
6. A method of treating tyrosinemia, comprising administering the pharmaceutical compositions of claim 1 to a patient in need thereof.
7. The method according to claim 6 , wherein the tyrosinemia is Hereditary Tyrosinemia type-1 (HT-1), or alkaptonuria.