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Claims for Patent: 9,301,932

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Claims for Patent: 9,301,932

Title:Liquid pharmaceutical composition comprising nitisinone
Abstract: The invention concerns a liquid pharmaceutical formulation suitable for oral administration, comprising a suspension of an effective amount of micronized 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (nitisinone); and citric acid buffer having a pH in the range of 2.5 to 3.5. The formulation is useful in the treatment of disorders and diseases in which inhibition of 4-hydroxyphenylpyruvate dioxygenase (HPPD) is desirable, e.g. in hereditary tyrosinaemia type I.
Inventor(s): Svensson; Lennart (Solna, SE), Siden; Hans (Sollentuna, SE)
Assignee: SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB (Stockholm, SE)
Application Number:14/129,090
Patent Claims: 1. A liquid pharmaceutical formulation suitable for oral administration, comprising (a) a suspension of 1 to 10 mg/ml of micronized 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione (nitisinone); and (b) a citric acid buffer, wherein the liquid pharmaceutical formulation has a pH in the range of 2.5 to 3.5.

2. The formulation according to claim 1 wherein the amount of nitisinone is 4 mg/ml.

3. The formulation according to claim 1, further comprising one or more pharmaceutically acceptable constituents selected from the group consisting of suspending agents, sweeteners, preservatives, surfactants, and flavoring agents.

4. The formulation according to claim 3 wherein the suspending agent is hydroxypropyl methylcellulose.

5. The formulation according to claim 4 wherein the suspending agent is hydroxypropyl methylcellulose in an amount of 1 to 20 mg/ml.

6. The formulation according to claim 3 wherein the sweetener is glycerol.

7. The formulation according to claim 6 wherein the sweetener is glycerol in an amount of 100 to 500 mg/ml.

8. The formulation according to claim 3 wherein the preservative is methyl paraben and/or propyl paraben.

9. The formulation according to claim 8 wherein the preservatives are methyl paraben in an amount of 1 to 2 mg/ml, and propyl paraben in an amount of 0.1 to 0.2 mg/ml.

10. The formulation according to claim 3 wherein the preservative is sodium benzoate in an amount of 0.2 to 5 mg/ml.

11. The formulation according to claim 3 wherein the surfactant is polysorbate 80.

12. The formulation according to claim 11 wherein the surfactant is polysorbate 80 in an amount of 0.1 to 20 mg/ml.

13. The formulation according to claim 1, comprising: (a) nitisinone (4 mg/ml); (b) citric acid monohydrate (9 mg/ml); (c) trisodium citrate dehydrate (2.1 mg/ml) (d) hydroxypropyl methylcellulose (5 mg/ml); (e) glycerol (500 mg/ml); (f) methyl paraben (1.4 mg/ml); (g) propyl paraben (0.14 mg/ml); and (h) polysorbate 80 (0.14 mg/ml).

14. The formulation according to claim 1, comprising: (a) nitisinone (4 mg/ml); (b) citric acid monohydrate (9 mg/ml); (c) trisodium citrate dehydrate (2.1 mg/ml) (d) hydroxypropyl methylcellulose (5 mg/ml); (e) glycerol (500 mg/ml); (f) sodium benzoate (1.0 mg/ml); and (g) polysorbate 80 (0.14 mg/ml).

15. The formulation according to claim 13, further comprising a flavoring agent.

16. A method of treating a medical condition in a subject, comprising administering to a subject in need of such treatment an effective amount of the formulation according to claim 1, wherein the medical condition is selected from the group consisting of tyrosinaemia, Parkinson's disease, depression, restless leg syndrome, and alkaptonuria.

17. The method according to claim 16, wherein the medical condition is hereditary tyrosinaemia type 1 (HT-1).

18. The method according to claim 17, wherein the medical condition is hereditary tyrosinaemia type 1 (HT-1) in a paediatric patient.

19. The formulation according to claim 14, further comprising a flavoring agent.

20. The formulation according to claim 1, wherein the liquid pharmaceutical formulation has a pH of 3.0.

21. The formulation according to claim 5, wherein the hydroxypropyl methylcellulose is in an amount of 5 mg/ml.

22. The formulation according to claim 7, wherein the glycerol is in an amount of 500 mg/ml.

23. The formulation according to claim 9, wherein the methyl paraben is present in an amount of 1.4 mg/ml, and the propyl paraben is present in an amount of 0.14 mg/ml.

24. The formulation according to claim 10, wherein the sodium benzoate is in an amount of 1 mg/ml.

25. The formulation according to claim 12, wherein the polysorbate 80 is an amount of 0.10 to 0.15 mg/ml.
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