Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Fuji
Federal Trade Commission
Colorcon
Healthtrust
Deloitte

Generated: August 21, 2019

DrugPatentWatch Database Preview

Claims for Patent: 5,529,915

  Try a free trial


See Plans and Pricing

« Back to Dashboard

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
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

Subscribe to access the full database, or try a Free Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Colorcon
Harvard Business School
Covington
McKesson
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.