Claims for Patent: 8,828,947

Summary for Patent: 8,828,947

Title:	Polypeptide formulation
Abstract:	The present invention relates to an aqueous pharmaceutical composition suitable for long-term storage of polypeptides containing an Fc domain of an immunoglobulin, methods of manufacture, methods of administration and kits containing same.
Inventor(s):	Gombotz; Wayne Richard (Kenmore, WA), Remmele, Jr.; Richard Louis (Mountain View, CA)
Assignee:	Immunex Corporation (Thousand Oaks, CA)
Application Number:	13/401,496
Patent Claims:	1. A kit comprising a composition comprising a polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1 and from about 10 mM to about 200 mM L-arginine, and instructions for use of said composition. 2. The kit of claim 1, wherein the composition is in a liquid state. 3. The kit of claim 2, wherein the composition is in a pre-filled sterile syringe. 4. The kit of claim 1, further comprising a buffer. 5. The kit of claim 4, wherein the buffer is selected from the group consisting of sodium phosphate, histidine, potassium phosphate, sodium or potassium citrate, maleic acid, ammonium acetate, tris-(hydroxymethyl)-aminomethane (tris), acetate and diethanolamine. 6. The kit of claim 1, further comprising a tonicity modifier. 7. The kit of claim 6, wherein the tonicity modifier is selected from the group consisting of arginine, cysteine, histidine, glycine, sodium chloride, potassium chloride, sodium citrate, sucrose, glucose and Mannitol. 8. The kit of claim 7, wherein the tonicity modifier is sodium chloride. 9. The kit of claim 1, further comprising an excipient. 10. The kit of claim 7, further comprising an excipient. 11. The kit of claim 9, wherein the excipient is selected from the group consisting of sucrose, lactose, glycerol, xylitol, sorbitol, Mannitol, maltose, inositol, trehalose, glucose, bovine serum albumin (BSA), human SA or recombinant HA, dextran, PVA, hydroxypropyl methylcellulose (HPMC), polyethyleneimine, gelatin, polyvinylpyrrolidone (PVP), hydroxyethylcellulose (HEC), polyethylene glycol, ethylene glycol, glycerol, dimethysulfoxide (DMSO), dimethylformamide (DMF), proline, L-serine, sodium glutamic acid, alanine, glycine, lysine hydrochloride, sarcosine, gamma-aminobutyric acid, polysorbate-20, polysorbate-80, SDS, polysorbate, polyoxyethylene copolymer, potassium phosphate, sodium acetate, ammonium sulfate, magnesium sulfate, sodium sulfate, trimethylamine N-oxide, betaine, zinc ions, copper ions, calcium ions, manganese ions, magnesium ions, CHAPS, sucrose monolaurate, and 2-O-beta-mannoglycerate. 12. The kit of claim 11, wherein the excipient is sucrose. 13. A kit comprising a stable pharmaceutical composition of about 10 mg/ml to about 100 mg/ml of a polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1, about 10 mM to about 200 mM L-arginine, and sodium phosphate, sodium chloride and sucrose. 14. The kit of claim 13, wherein L-arginine is about 10 mM to about 75 mM. 15. The kit of claim 13, wherein sodium phosphate is about 5 mM to about 100 mM. 16. The kit of claim 13, wherein sucrose is about 0.5% to about 1.5%. 17. The kit of claim 13, wherein pH is about 5.5 to about 7.8. 18. The kit of claim 13, having about 50 mg/ml of the polypeptide that is an extracellular ligand-binding portion of a human p75 tumor necrosis factor receptor fused to the Fc region of a human IgG1, about 25 mM L-arginine, about 25 mM sodium phosphate, about 98 mM sodium chloride, about 1% sucrose, and wherein the composition is about pH 6.2. 19. The kit of claim 1, wherein the polypeptide is etanercept. 20. The kit of claim 4, wherein the polypeptide is etanercept. 21. The kit of claim 6, wherein the polypeptide is etanercept. 22. The kit of claim 9, wherein the polypeptide is etanercept. 23. The kit of claim 13, wherein the polypeptide is etanercept.

Details for Patent 8,828,947

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2022-02-27
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2022-02-27
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2022-02-27