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US 8,044,020 B2Granted
Pharmaceutical compositions and methods for insulin treatment
AssigneeCPEX Pharmaceuticals, Inc.
InventorsRobert J. Gyurik, Carl Reppucci
Life of this patent
Estimating the term…
Abstract
Compositions and methods for treating a patient with insulin that combines insulin, a permeation enhancer, and a carrier that maintains an acidic pH, are disclosed.
Claims32
A pharmaceutical composition comprising:
- a therapeutically effective amount of insulin, a permeation enhancer, and a liquid carrier;
- said composition being at an acidic pH, but no greater than a pH of 4.5;
- and the permeation enhancer being a Hsieh enhancer having the following structure:
- wherein X and Y are oxygen, sulfur or an imino group of the structure
- or =N—R with the proviso that when Y is the imino group, X is an imino group, and when Y is sulfur, X is sulfur or an imino group, A is a group having the structure
- wherein X and Y are defined above, m and n are integers having a value from 1 to 20 and the sum of m+n is not greater than 25, p is an integer having a value of 0 or 1, q is an integer having a value of 0 or 1, r is an integer having a value of 0 or 1, and each of R, R1, R2, R3, R4, R5 and R6 is independently hydrogen or an alkyl group having from 1 to 6 carbon atoms which may be straight chained or branched provided that only one of R1 to R6 can be an alkyl group, with the proviso that when p, q and r have a value of 0 and Y is oxygen, m+n is at least 11, and with the further proviso that when X is an imino group, q is equal to 1, Y is oxygen, and p and r are 0, then m+n is at least 11.
3 more elements
A pharmaceutical composition comprising:
- an aqueous phase containing a therapeutically effective amount of insulin and a permeation enhancer emulsified in said aqueous phase, said composition being at an acidic pH, but no greater than a pH of 4.5, and said permeation enhancer being a Hsieh enhancer having the following structure:
- wherein X and Y are oxygen, sulfur or an imino group of the structure
- or =N—R with the proviso that when Y is the imino group, X is an imino group, and when Y is sulfur, X is sulfur or an imino group, A is a group having the structure
- wherein X and Y are defined above, m and n are integers having a value from 1 to 20 and the sum of m+n is not greater than 25, p is an integer having a value of 0 or 1, q is an integer having a value of 0 or 1, r is an integer having a value of 0 or 1, and each of R, R1, R2, R3, R4, R5 and R6 is independently hydrogen or an alkyl group having from 1 to 6 carbon atoms which may be straight chained or branched provided that only one of R1 to R6 can be an alkyl group, with the proviso that when p, q and r have a value of 0 and Y is oxygen, m+n is at least 11, and with the further proviso that when X is an imino group, q is equal to 1, Y is oxygen, and p and r are 0, then m+n is at least 11.
1 more element
A method for treating a patient in need of insulin comprising administering to the patient a pharmaceutical composition comprising:
- a therapeutically effective amount of insulin, a permeation enhancer, and a liquid carrier;
- said composition being at an acidic pH, but no greater than a pH of 4.5;
- and the permeation enhancer being a Hsieh enhancer having the following structure:
- wherein X and Y are oxygen, sulfur or an imino group of the structure
- or =N—R with the proviso that when Y is the imino group, X is an imino group, and when Y is sulfur, X is sulfur or an imino group, A is a group having the structure
- wherein X and Y are defined above, m and n are integers having a value from 1 to 20 and the sum of m+n is not greater than 25, p is an integer having a value of 0 or 1, q is an integer having a value of 0 or 1, r is an integer having a value of 0 or 1, and each of R, R1, R2, R3, R4, R5 and R6 is independently hydrogen or an alkyl group having from 1 to 6 carbon atoms which may be straight chained or branched provided that only one of R1 to R6 can be an alkyl group, with the proviso that when p, q and r have a value of 0 and Y is oxygen, m+n is at least 11, and with the further proviso that when X is an imino group, q is equal to 1, Y is oxygen, and p and r are 0, then m+n is at least 11.
3 more elements
Dependencies are inferred from the claim text.