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Last Updated: December 22, 2024

Claims for Patent: 10,328,029

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Summary for Patent: 10,328,029

Title:	Pharmaceutical composition
Abstract:	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.
Inventor(s):	Harrison; James (Little Shelford, GB), Fuller; Stephen (Cambridge, GB), Brown; Tobias Josef (Cambridge, GB)
Assignee:	CYCLE PHARMACEUTICALS LTD (Cambridge, Cambridgeshire, GB)
Application Number:	15/109,220
Patent Claims:	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.

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