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Last Updated: April 25, 2024

Claims for Patent: 5,529,915

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Summary for Patent: 5,529,915

Title:	Lyophilized polyethylene oxide modified protein and polypeptide complexes with cyclodextrin
Abstract:	Disclosed are lyophilized biologically active proteinaceous compositions containing low diol polyalkylene oxide, such as polyethylene glycol, covalently attached to a biologically active proteinaceous substance and combined with the cryoprotectant cyclodextrin.
Inventor(s):	Phillips; Christopher P. (Brandamore, PA), Snow; Robert A. (West Chester, PA)
Assignee:	Sterling Winthrop Inc. (New York, NY)
Application Number:	08/372,621
Patent Claims:	1. A process of preparing a lyophilized biologically active proteinaceous composition comprising the steps of: a) carboxylating polyethylene glycol containing less than 10% w/w non-monomethoxylated polyethylene glycol; b) activating said carboxylated polyethylene glycol to obtain an active polyethylene glycol ester; c) covalently attaching said active polyethylene glycol ester to a biologically active protein. d) solubilizing said covalently attached polyethylene glycol ester and said biologically active protein in an aqueous media; e) solubilizing cyclodextrin in said aqueous media to obtain a homogeneous solution; f) buffering said solution to a pH of from about 5.7 to about 6.5; and h) lyophillzing the solution. 2. The process of claim 1 wherein said solution for lyophilization comprises: from about 150 to about 150,000 unit/ml of a covalently bound low diol polyethylene glycol/protein; from about 0.1 to about 20% w/v of cyclodextrin; and from about 0.01 to about 50 mM of a buffer. 3. The process of claim 2 wherein said polyethylene glycol has an average molecular weight of from about 1,000 to about 15,000 daltons. 4. The process of claim 2 wherein said cyclodextrin is a derivative of .beta.-cyclodextrin. 5. The process of claim 4 wherein said .beta.-cyclodextrin derivative is hydroxypropyl cyclodextrin. 6. The process of claim 4 wherein said .beta.-cyclodextrin derivative is maltosyl cyclodextrin. 7. The process of claim 4 wherein said .beta.-cyclodextrin derivative is maltotriosyl cyclodextrin. 8. The process of claim 1 wherein said protein is selected from the group consisting of: Recombinant human interleukin-4 (rhuIL-4); Protease Subtilisin Carlsberg; Oxidoreductase; Catalase; Cholesterol, reduced-NADP: oxygen oxidoreductase (20-.beta.-hydroxylating) (1.14.1.9; "Cholesterol 20-hydroxylase"); Transferase; UDP glucose; Hydrolase; Trypsin (3.4.4.4); L-Asparagine aminohydrolase (3.5.1.1; "Asparaginase"); Lyase; Isomerase and Ligase. 9. The process of claim 2 wherein said protein is selected from the group consisting of: Insulin; ACTH; Glucagon; Somatostatin; Somatotropin; Thymosin; Parathyroid hormone; Pigmentary Hormone; Somatomedin; Erythropoietin and Luteinizing Hormone. 10. The process of claim 2 wherein said protein is selected from the group consisting of: Chorionic Gonadotropin; Hypothalmic Releasing Factor; Antidiuretic Hormone; Thyroid Stimulating Hormone; Calcitenin; Prolactin; Interferon (alpha, beta and gamma); Antibodies (IgG, IgE, IgM, IgD); Interleukins 1, 2, 3, 4 and 7; Granulocyte Colony Stimulating Factor (GCSF); Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF). 11. The process of claim 2 wherein said protein is selected from the group consisting of: Tumor Necrosis Factor (TNF); Platelet Derived Growth Factor (PDGF); Epidermal Growth Factor (EGF); Nerve Growth Factor (NGF); Bone Growth Factor (BGF); Growth Hormone Releasing Factor (GHRF); Papain; Chymotrypsin; Thermolysin; Streptokinase and Activase.

Details for Patent 5,529,915

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	01/15/1974	⤷ Try a Trial	2013-06-25
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	12/27/1984	⤷ Try a Trial	2013-06-25
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	02/15/1985	⤷ Try a Trial	2013-06-25
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	02/16/1990	⤷ Try a Trial	2013-06-25
Bel-mar Laboratories, Inc.	CHORIONIC GONADOTROPIN	chorionic gonadotropin	Injection	017054	03/26/1974	⤷ Try a Trial	2013-06-25
Fresenius Kabi Usa, Llc	CHORIONIC GONADOTROPIN	chorionic gonadotropin	For Injection	017067	03/05/1973	⤷ Try a Trial	2013-06-25
Recordati Rare Diseases, Inc.	ELSPAR	asparaginase	For Injection	101063	01/10/1978	⤷ Try a Trial	2013-06-25
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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