Claims for Patent: 8,257,691

Summary for Patent: 8,257,691

Title:	Composition and dosage form comprising a particle formulation and suspending vehicle
Abstract:	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.
Inventor(s):	Eliaz; Rom Ezer (Sunnyvale, CA), Zhang; Yuanpeng (Cupertino, CA), Rohloff; Catherine Manya (Cupertino, CA), Weeks; Eric William (Oakland, CA), Junnarkar; Gunjan (Palo Alto, CA)
Assignee:	Intarcia Therapeutics, Inc. (Hayward, CA)
Application Number:	13/090,947
Patent Claims:	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 .mu.m to about 10 .mu.m 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 .mu.m to about 10 .mu.m in diameter.

Details for Patent 8,257,691

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2039-02-26