Composition and dosage form comprising a 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 method of preparing a pharmaceutical composition comprising:
adding a particle formulation that comprises a protein or peptide, sucrose, methionine, and citrate buffer to a suspending vehicle that comprises a solvent selected from the group consisting of benzyl benzoate, lauryl lactate, and lauryl alcohol, to provide the pharmaceutical composition.
2. The method of claim 1 , wherein said protein or peptide is selected from the group consisting of erythropoietin, human growth hormone, granulocyte macrophage colony stimulating factor, human growth hormone releasing hormone, insulin, infliximab, and glucagon-like peptide-1.
3. The method of claim 2 , wherein the protein or peptide is glucagon-like peptide-1.
4. The method of claim 1 , wherein the particle formulation comprises the protein or peptide, sucrose, methionine, and citrate buffer in a weight ratio of 1:2:1:2.15.
5. The method of claim 4 , wherein the solvent is benzyl benzoate.
6. The method of claim 1 , wherein the solvent is benzyl benzoate.
7. The method of claim 1 , wherein the solvent is lauryl lactate.
8. The method of claim 1 , wherein the suspending vehicle further comprises a lipid.
9. The method of claim 8 , 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.
10. The method of claim 1 , wherein the particle formulation comprises spray-dried particles.
11. The method of claim 10 , wherein the particle size is from about 1 μm to about 10 μm in diameter.
12. A method of preparing an osmotic drug delivery device comprising:
loading a pharmaceutical composition into a chamber of the osmotic drug delivery device to prepare the osmotic drug delivery device, the pharmaceutical composition comprising
(i) a particle formulation comprising a protein or peptide, sucrose, methionine, and 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.
13. The method of claim 12 , wherein said protein or peptide is selected from the group consisting of erythropoietin, human growth hormone, granulocyte macrophage colony stimulating factor, human growth hormone releasing hormone, insulin, infliximab, and glucagon-like peptide-1.
14. The method of claim 13 , wherein the protein or peptide is glucagon-like peptide-1.
15. The method of claim 12 , wherein the particle formulation comprises the protein or peptide, sucrose, methionine, and citrate buffer in a weight ratio of 1:2:1:2.15.
16. The method of claim 15 , wherein the solvent is benzyl benzoate.
17. The method of claim 12 , wherein the solvent is benzyl benzoate.
18. The method of claim 12 , wherein the solvent is lauryl lactate.
19. The method of claim 12 , wherein the suspending vehicle further comprises a lipid.
20. The method of claim 19 , 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.
21. The method of claim 12 , wherein the particle formulation comprises spray-dried particles.
22. The method of claim 21 , wherein the particle size is from about 1 μm to about 10 μm in diameter.