Crystalline pyridazine compound
A crystalline compound of formula (1) and its salts and solvates are provided for the treatment or prophylaxis of hepatitis C virus infections Methods of making and formulating crystalline compound (1) are provided.
1. A pharmaceutical composition comprising a compound of formula (1)
and one or more fatty acids.
2. The pharmaceutical composition of claim 1 wherein the fatty acid is a saturated or unsaturated 4-22 carbon chain.
3. The pharmaceutical composition of claim 1 wherein the fatty acid is linoleic, oleic, lauric, palmitic or myristic acid.
4. The pharmaceutical composition of claim 1 wherein the fatty acid is oleic acid.
5. The pharmaceutical composition of claim 4 wherein compound (1) is 8% by weight and the oleic acid is 92% by weight.
6. The pharmaceutical composition of claim 1 wherein compound (1) is 20% by weight and the oleic acid is 80% by weight.
7. The pharmaceutical composition of claim 1 further comprising polyethylene glycols, or short, medium, or long chain mono, di, or triglycerides, or pegylated short, medium or long chain fatty acids.
8. The pharmaceutical composition of claim 3 further comprising one or more surfactants selected from fatty acid esters of polyoxyethylene sorbitan, sorbitan fatty acid ester, polyoxyethylene castor oil derivatives, polyoxyethleneglycerol oxystearate, polyethyleneglycol 60, hydrogenated castor oil, and block copolymers of ethylene oxide and propylene oxide.
9. The pharmaceutical composition of claim 8 wherein the fatty acid is oleic acid and the surfactant is polyoxyethylene sorbitan.
10. The pharmaceutical composition of claim 9 comprising 8% of compound (1), 87.4% of oleic acid and 4.6% of polyoxyethylene sorbitan, by weight.
11. The pharmaceutical composition of claim 9 comprising 20% of compound (1), 76% of oleic acid and 4% of polyoxyethylene sorbitan, by weight.
12. The pharmaceutical composition of claim 9 comprising 8% of compound (1), 86.47% of oleic acid, 4.6% of polyoxyethylene sorbitan, 0.92% Aerosil 200, and 0.01% BHT, by weight.
13. The pharmaceutical composition of claim 9 comprising 8% of compound (1), 85.55% of oleic acid, 4.6% of polyoxyethylene sorbitan, 1.84% Aerosil 200, and 0.01% BHT, by weight.
14. The pharmaceutical composition of claim 9 comprising 10% of compound (1), 84.55% of oleic acid, 5.00% of polyoxyethylene sorbitan, 0.35% BHA, and 0.1% BHT, by weight.
15. The pharmaceutical composition of claim 9 further comprising one or more alcohols selected from ethanol, benzyl alcohol, glycerol, polyethylene glycol 200, polyethylene glycol 300, and polyethylene glycol 400.
16. The pharmaceutical composition of claim 9 comprising 8% of compound (1), 73.6% of oleic acid, 9.2% of polyoxyethylene sorbitan, and 9.2% of ethanol, by weight.
17. A pharmaceutical dosage form comprising a compound of formula (1)
and one or more fatty acids selected from oleic, lauric, palmitic and myristic acid.
18. The pharmaceutical dosage form of claim 17 comprising oleic acid and polyoxyethylene sorbitan.
19. The pharmaceutical dosage form of claim 17 wherein the dosage form is a capsule.