US2021069334A1PendingUtilityA1
Pharmaceutical formulations
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
exact text as granted — not AI-modifiedWhat 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.Cited by (0)
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