Syringe
The present invention relates to a syringe, particularly to a small volume syringe such as a syringe suitable for ophthalmic injections.
1. A pre-filled, terminally sterilized syringe for intravitreal injection, the syringe comprising a glass body forming a barrel, a stopper and a plunger and containing an ophthalmic solution which comprises a VEGF-antagonist, wherein:
(a) the syringe has a nominal maximum fill volume of between about 0.5 ml and about 1 ml,
(b) the syringe barrel comprises from about 1 μg to 100 ug silicone oil,
(c) the VEGF antagonist solution comprises no more than 2 particles >50 μm in diameter per ml and wherein the syringe has a stopper break loose force of less than about 11N.
2. A pre-filled syringe according to claim 1 , wherein the syringe barrel has an internal coating of silicone oil that has an average thickness of about 450 nm or less.
3. A pre-filled syringe according to claim 1 , wherein the syringe barrel has an internal coating of from about 3 μg to about 100 ug silicone oil.
4. A pre-filled syringe according to claim 1 , wherein the silicone oil is DC365 emulsion.
5. A pre-filled syringe according to claim 1 , wherein the VEGF antagonist solution further comprises one or more of (i) no more than 5 particles ≧25 μm in diameter per ml, and (ii) no more than 50 particles ≧10 μm in diameter per ml.
6. A pre-filled syringe according to claim 1 , wherein the VEGF antagonist solution meets USP789.
7. A pre-filled syringe according to claim 1 , wherein the VEGF antagonist is an anti-VEGF antibody.
8. A pre-filled syringe according to claim 7 , wherein the anti-VEGF antibody is ranibizumab.
9. A pre-filled syringe according to claim 8 , wherein the ranibizumab is at a concentration of 10 mg/ml.
10. A pre-filled syringe according to claim 8 , wherein the silicone oil has a viscosity of about 350 cP, and the VEGF antagonist solution further comprises one or more of (i) no more than 5 particles ≧25 μm in diameter per ml, and (ii) no more than 50 particles ≧10 μm in diameter per ml.
11. A pre-filled syringe according to claim 1 wherein the VEGF antagonist is a non-antibody VEGF antagonist.
12. A pre-filled syringe according to claim 11 , wherein the non-antibody VEGF antagonist is aflibercept or conbercept.
13. A pre-filled syringe according to claim 12 , wherein the non-antibody VEGF antagonist is aflibercept at a concentration of 40 mg/ml.
14. A pre-filled syringe according to claim 1 , wherein the syringe has a stopper break loose force of less than about 5N, and wherein the syringe has a stopper slide force of less than about 5N.
15. A pre-filled syringe according to claim 14 , wherein the stopper break loose force or stopper slide force is measured using a filled syringe, at a stopper travelling speed of 190 mm/min, with a 30 G×0.5 inch needle attached to the syringe.
16. A pre-filled syringe according to claim 1 , wherein the syringe has a stopper slide force of less than about 11N.
17. A blister pack comprising a pre-filled syringe according to claim 1 , wherein the syringe has been sterilised using H 2 O 2 or EtO.
18. A blister pack comprising a pre-filled syringe according to claim 17 , wherein the outer surface of the syringe has ≦1 ppm EtO or H 2 O 2 residue.
19. A blister pack comprising a pre-filled syringe according to claim 17 , wherein the syringe has been sterilised using EtO or H 2 O 2 and the total EtO or H 2 O 2 residue found on the outside of the syringe and inside of the blister pack is ≦0.1 mg.
20. A blister pack comprising a pre-filled syringe according to claim 18 , wherein ≦5% of the VEGF antagonist is alkylated.
21. A blister pack comprising a pre-filled syringe according to claim 17 , wherein the syringe has been sterilised using EtO or H 2 O 2 with a Sterility Assurance Level of at least 10 −6 .
22. A pre-filled syringe according to claim 1 , wherein the syringe barrel has an internal coating of from about 1-50 μg silicone oil.
23. A pre-filled syringe according to claim 1 , wherein the silicone oil has a viscosity of about 350 cP.
24. A method of treating a patient suffering from of an ocular disease selected from choroidal neovascularisation, wet age-related macular degeneration, macular edema secondary to retinal vein occlusion (RVO) including both branch RVO (bRVO) and central RVO (cRVO), choroidal neovascularisation secondary to pathologic myopia (PM), diabetic macular edema (DME), diabetic retinopathy, and proliferative retinopathy, comprising the step of administering an ophthalmic solution to the patient using a pre-filled syringe according to claim 1 .
25. The method of claim 24 , further comprising an initial priming step in which the physician depresses the plunger of the pre-filled syringe to align the pre-determined part of the stopper with the priming mark.
26. A method according to claim 24 , wherein the VEGF antagonist administered is a non-antibody VEGF antagonist and wherein the patient has previously received treatment with an antibody VEGF antagonist.