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Last Updated: July 16, 2020

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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

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Ferring CHORIONIC GONADOTROPIN gonadotropin, chorionic INJECTABLE;INJECTION 017016 004 1975-06-26   Start Trial Sterling Winthrop Inc. (New York, NY) 2013-06-25 RX search
Ferring CHORIONIC GONADOTROPIN gonadotropin, chorionic INJECTABLE;INJECTION 017016 006 1975-06-26   Start Trial Sterling Winthrop Inc. (New York, NY) 2013-06-25 RX search
Ferring CHORIONIC GONADOTROPIN gonadotropin, chorionic INJECTABLE;INJECTION 017016 007 1975-06-26   Start Trial Sterling Winthrop Inc. (New York, NY) 2013-06-25 RX search
Ferring CHORIONIC GONADOTROPIN gonadotropin, chorionic INJECTABLE;INJECTION 017016 009 1975-06-26   Start Trial Sterling Winthrop Inc. (New York, NY) 2013-06-25 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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