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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)|
|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) (18.104.22.168; "Cholesterol 20-hydroxylase"); Transferase; UDP glucose; Hydrolase; Trypsin (22.214.171.124); L-Asparagine aminohydrolase (126.96.36.199; "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.
|Applicant||Tradename||Biologic Ingredient||Dosage Form||BLA||Number||Approval Date||Patent No.||Assignee||Estimated Patent Expiration||Status||Orphan||Source|
|Merck||ELSPAR||asparaginase||VIAL||101063||001||1978-01-10||Try a Free Trial||Sterling Winthrop Inc. (New York, NY)||2013-06-25||RX||search|
|Genentech||ACTIVASE||alteplase||VIAL; SINGLE-USE||103172||001||1987-11-13||Try a Free Trial||Sterling Winthrop Inc. (New York, NY)||2013-06-25||RX||search|
|Genentech||ACTIVASE||alteplase||VIAL; SINGLE-USE||103172||002||1987-11-13||Try a Free Trial||Sterling Winthrop Inc. (New York, NY)||2013-06-25||RX||search|
|Genentech||CATHFLO ACTIVASE||alteplase||VIAL||103172||003||1987-11-13||Try a Free Trial||Sterling Winthrop Inc. (New York, NY)||2013-06-25||RX||search|
|Nps Pharms Inc||NATPARA||parathyroid hormone||INJECTABLE;INJECTION||125511||001||2015-01-23||Try a Free Trial||Sterling Winthrop Inc. (New York, NY)||2013-06-25||RX||Orphan||search|
|Nps Pharms Inc||NATPARA||parathyroid hormone||INJECTABLE;INJECTION||125511||002||2015-01-23||Try a Free Trial||Sterling Winthrop Inc. (New York, NY)||2013-06-25||RX||Orphan||search|
|>Applicant||>Tradename||>Biologic Ingredient||>Dosage Form||>BLA||>Number||>Approval Date||>Patent No.||>Assignee||>Estimated Patent Expiration||>Status||>Orphan||>Source|
|Country||Patent Number||Publication Date|
|United States of America||5298410||Mar 29, 1994|
|United States of America||5334382||Aug 02, 1994|
|United States of America||5389381||Feb 14, 1995|
|Taiwan||260611||Oct 21, 1995|
|Slovakia||23294||Feb 08, 1995|
|Russian Federation||94006023||Apr 20, 1996|
|>Country||>Patent Number||>Publication Date|
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