Composition and dosage form comprising an interferon particle formulation and suspending vehicle
View Patent ↗A liquid composition in an osmotic drug delivery system and a dosage form in an osmotic drug delivery system is disclosed comprising an amphiphilic molecule, a non-aqueous liquid solvent, and a pharmaceutically active agent.
1. A pharmaceutical composition comprising:
a particle formulation comprising an interferon, sucrose, methionine, and a citrate buffer, and
a suspending vehicle comprising a solvent selected from the group consisting of benzyl benzoate, lauryl lactate, and lauryl alcohol, wherein the particle formulation is dispersed in the suspending vehicle.
2. The pharmaceutical composition of claim 1 , wherein said interferon is omega-interferon.
3. An osmotic drug delivery device comprising
a pharmaceutical composition comprising, (i) a particle formulation comprising an interferon, sucrose, methionine, and a citrate buffer, and (ii) a suspending vehicle comprising a solvent selected from the group consisting of benzyl benzoate, lauryl lactate, and lauryl alcohol, wherein the particle formulation is dispersed in the suspending vehicle.
4. The device of claim 3 , wherein said interferon is omega-interferon.
5. The pharmaceutical composition of claim 1 , wherein the interferon is selected from the group consisting of omega-interferon, alpha-interferon, beta-interferon, and gamma-interferon.
6. The pharmaceutical composition of claim 1 , wherein the solvent is benzyl benzoate.
7. The pharmaceutical composition of claim 1 , wherein the solvent is lauryl lactate.
8. The pharmaceutical composition of claim 1 , wherein the solvent is lauryl alcohol.
9. The pharmaceutical composition of claim 1 , wherein the suspending vehicle further comprises a lipid.
10. The pharmaceutical composition of claim 9 , wherein the lipid is selected from the group consisting of dioleoyl phosphatidylcholine, dimyristoylphosphatidylcholine, dipalmitoylphosphatidylcholine, distearoylphosphatidylcholine, egg phosphatidylcholine, soy phosphatidylcholine, partially hydrogenated phosphatidylcholines, fully hydrogenated phosphatidylcholines, palmitoyl-oleoyl phosphatidylcholine, stearyloleoylphosphatidylcholine, dioleoy phosphatidylglycerol, dimyristoylphosphatidylglycerol, dipalmitoylphosphatidylglycerol, distearoylphosphatidylglycerol, and mixtures thereof.
11. The pharmaceutical composition of claim 1 , wherein the particle formulation comprises spray-dried particles.
12. The pharmaceutical composition of claim 11 , wherein the particle size is from about 1 to about 10 μm in diameter.
13. The device of claim 3 , wherein the interferon is selected from the group consisting of omega-interferon, alpha-interferon, beta-interferon, and gamma-interferon.
14. The device of claim 3 , wherein the solvent is benzyl benzoate.
15. The device of claim 3 , wherein the solvent is lauryl lactate.
16. The device of claim 3 , wherein the solvent is lauryl alcohol.
17. The device of claim 3 , wherein the suspending vehicle further comprises a lipid.
18. The device of claim 17 , wherein the lipid is selected from the group consisting of dioleoyl phosphatidylcholine, dimyristoylphosphatidylcholine, dipalmitoylphosphatidylcholine, distearoylphosphatidylcholine, egg phosphatidylcholine, soy phosphatidylcholine, partially hydrogenated phosphatidylcholines, fully hydrogenated phosphatidylcholines, palmitoyl-oleoyl phosphatidylcholine, stearyloleoylphosphatidylcholine, dioleoy phosphatidylglycerol, dimyristoylphosphatidylglycerol, dipalmitoylphosphatidylglycerol, distearoylphosphatidylglycerol, and mixtures thereof.
19. The device of claim 3 , wherein the particle formulation comprises spray-dried particles.
20. The device of claim 19 , wherein the particle size is from about 1 to about 10 μm in diameter.
21. The pharmaceutical composition of claim 1 , wherein the particle formulation comprises the interferon, sucrose, methionine, and citrate buffer in a weight ratio of 1:2:1:2.15.
22. The device of claim 3 , wherein the particle formulation comprises the interferon, sucrose, methionine, and citrate buffer in a weight ratio of 1:2:1:2.15.
23. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition is substantially homogenous for at least 3 months.
24. The device of claim 3 , wherein the pharmaceutical composition is substantially homogenous for at least 3 months.