Aqueous protein solutions stable to denaturation
First Claim
1. A sterile aqueous solution of a water soluble biologically active protein, which solution has a pH between 6.8 and 8 and additionally has admixed therewith from 2 to 500 ppm of a surface active compound of the formula
whereby said solution is stabilized to motion conditions, whereinXn is a chain of n members selected from the group of members having the formula ##STR7## in any sequence, n is 2 to 80,Y is --O-- or --NH--,R1 is --H, --CH3, or --C2 H5, and may be the same or different but is such that at least one-half of the members of the chain Xn contains --CH3 or --C2 H5, andR2 and R3 are each members independently selected from the group consisting of hydrogen, alkyl having 1 to 20 carbon atoms, carboxyalkyl having 2 to 20 carbon atoms, and alkylphenyl having 1 to 10 alkyl carbon atoms, but wherein R2 may only be such alkyl if Y is --NH--.
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Abstract
What are disclosed are a method for preventing the denaturation of proteins such as insulin in aqueous solution at interfaces by the addition to the solution of a surface-active substance comprising a chain of alternating weakly hydrophobic and weakly hydrophilic zones, protein solutions containing such a surface-active substance, methods of purifying proteins contained in such solutions, and methods of treating surfaces with such a surface-active material to prevent the denaturation of proteins thereon.
59 Citations
8 Claims
- 1. A sterile aqueous solution of a water soluble biologically active protein, which solution has a pH between 6.8 and 8 and additionally has admixed therewith from 2 to 500 ppm of a surface active compound of the formula
- space="preserve" listing-type="equation">R.sup.2 Y--X.sub.n --R.sup.3
whereby said solution is stabilized to motion conditions, wherein Xn is a chain of n members selected from the group of members having the formula ##STR7## in any sequence, n is 2 to 80, Y is --O-- or --NH--, R1 is --H, --CH3, or --C2 H5, and may be the same or different but is such that at least one-half of the members of the chain Xn contains --CH3 or --C2 H5, and R2 and R3 are each members independently selected from the group consisting of hydrogen, alkyl having 1 to 20 carbon atoms, carboxyalkyl having 2 to 20 carbon atoms, and alkylphenyl having 1 to 10 alkyl carbon atoms, but wherein R2 may only be such alkyl if Y is --NH--. - View Dependent Claims (2, 3, 4)
- 5. A sterile aqueous solution of a water soluble protein which additionally has admixed therewith from 2 to 200 ppm of a surface active compound of the formula
- space="preserve" listing-type="equation">R.sup.2 Y--X.sub.n --R.sup.3
whereby said solution is stabilized to motion conditions, wherein Xn is a chain of n members selected from the group of members having the formulas ##STR8## in any sequence, n is 2 to 80, Y is --O-- or --NH--, R1 is --H, --CH3, or --C2 H5, and may be the same or different but is such that at least one-half of the members of the chain Xn contains --CH3 or --C2 H5, and R2 and R3 are each members independently selected from the group consisting of hydrogen, alkyl having 1 to 20 carbon atoms, carboxyalkyl having 2 to 20 carbon atoms, and alkylphenyl having 1 to 10 alkyl carbon atoms, but wherein R2 may only be such alkyl if Y is --NH--. - View Dependent Claims (6, 7, 8)
Specification
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- Resources
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Current AssigneeAventis Pharma Deutschland GmbH (Sanofi )
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Original AssigneeHoechst Aktiengesellschaft (Sanofi )
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InventorsThurow, Horst
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Primary Examiner(s)WADDELL, FREDERICK
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Application NumberUS07/136,673Time in Patent Office714 DaysField of Search514/3, 514/2, 514/12, 514/13, 514/15, 424/85.4, 424/85.6, 424/85.7, 424/85.5, 424/94.1, 424/94.61, 424/94.64US Class Current424/85.4CPC Class CodesA61K 38/00 Medicinal preparations cont...A61K 47/10 Alcohols; Phenols; Salts th...C07K 14/62 Insulins
