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Last Updated: September 28, 2020

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Patent: 7,501,455

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Summary for Patent: 7,501,455
Title:Pharmaceutical compositions containing plasma protein
Abstract: The invention is related to water-soluble products and pharmaceutical formulations in solid or liquid form mainly for parenteral use. They consist of or comprise a therapeutically active substance (having low aqueous solubility and a substantial binding affinity to plasma proteins) and a plasma protein fraction in controlled aggregation state, whereby the said active substance and the said protein fraction are bound to each other by way of non-covalent bonds. It also covers processes for the preparation of the product and pharmaceutical formulation by dissolving the water-insoluble active substance in a water-miscible, pharmaceutically acceptable solvent, combining said solution with the aqueous solution of a plasma protein fraction in controlled aggregation state whereby a true solution is obtained containing the said active substance and the said protein fraction bound together by way of non-covalent bonds. Optionally a further pharmaceutically acceptable auxiliary additive--such as a protein aggregation controller and/or a stabilizer--may be present. The organic solvent is eliminated by dialyzing, ultrafiltrating, diafiltrating and/or lyophilising. The solid products consisting of the active substance and the protein are also protected. On optional dissolution in water clear, liquid compositions are obtained suitable for direct parenteral or other administration. Method of treatment is also covered. A series of water-insoluble substances is enlisted with appropriate protein fractions to be used.
Inventor(s): Hegedus; Lajos (Budapest, HU), Krempels; Krisztina (Budapest, HU), Paal; Krisztina (Budapest, HU), Petho; Gabor (Budapest, HU)
Assignee: Sicor, Inc. (Irvine, CA)
Application Number:10/802,528
Patent Claims:see list of patent claims

Details for Patent 7,501,455

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Grifols Usa, Llc PLASBUMIN albumin (human) SOLUTION 101138 1 1994-09-26   Start Trial Sicor, Inc. (Irvine, CA) 2040-01-28 search
Baxalta Us Inc. FLEXBUMIN albumin human INJECTION, SOLUTION 101452 1 2014-07-31   Start Trial Sicor, Inc. (Irvine, CA) 2040-01-28 search
Csl Behring Ag ALBURX albumin (human) SOLUTION 102366 1 2009-01-06   Start Trial Sicor, Inc. (Irvine, CA) 2040-01-28 search
Grifols Usa, Llc ALBUTEIN albumin (human) INJECTION, SOLUTION 102478 1 2019-12-15   Start Trial Sicor, Inc. (Irvine, CA) 2040-01-28 search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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