US2021069334A1PendingUtilityA1

Pharmaceutical formulations

69
Assignee: AMGEN INCPriority: Aug 5, 2005Filed: Apr 22, 2020Published: Mar 11, 2021
Est. expiryAug 5, 2025(expired)· nominal 20-yr term from priority
A61K 38/193A61K 9/0019A61K 47/186A61K 9/19A61K 47/10A61K 47/18A61K 2039/505A61K 47/02A61K 47/26A61K 38/1816A61K 39/39533A61K 39/39591C07K 14/475A61K 47/183A61K 47/20
69
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Claims

Abstract

A method of stabilizing an aqueous protein or antibody formulation is disclosed herein. Additionally, stable pharmaceutical formulations are contemplated which comprise a biologically active protein, a destabilizing concentration of preservative and a stabilizing concentration of osmolyte.

Claims

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What is claimed is: 
     
         1 - 32 . (canceled) 
     
     
         33 . A method for screening for optimal stabilizing concentration of osmolyte comprising the steps of
 a) assessing the stability of a first aqueous solution comprising a first concentration of osmolyte, a therapeutic protein, and a preservative;   b) assessing the stability of a second aqueous solution comprising a different second concentration of osmolyte, a therapeutic protein, and a preservative; and   c) determining that the first concentration of osmolyte is more optimal than the second concentration of osmolyte if the first aqueous solution is more stable.   
     
     
         34 . The method of  claim 33 , wherein the stability is assessed via size exclusion chromatography or circular dichroism.

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