Pharmaceutical compositions and methods for peptide treatment
AssigneeCPEX Pharmaceuticals, Inc.
InventorsRobert J. Gyurik, Carl Reppucci
Life of this patent
Estimating the term…
Abstract
Disclosed are compositions and methods for treating a patient with a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins, wherein the pharmaceutical composition is in the form of an emulsified nasal spray comprising: a macrocyclic permeation enhancer, a liquid carrier comprising water, and a therapeutically effective amount of a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins; wherein the macrocyclic permeation enhancer is a Hsieh enhancer emulsified in the liquid carrier.
Claims16
A pharmaceutical composition in the form of an emulsion suitable for delivery to a mucous membrane comprising:
- a macrocyclic permeation enhancer, a liquid carrier, a hydrocolloid emulsifying agent, and a therapeutically effective amount of a pharmaceutically active agent other than insulin selected from the group consisting of peptides and proteins;
- wherein said macrocyclic permeation enhancer is a Hsieh enhancer;
- said 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 of the structure ═N—R, X is an imino group of the structure
- and when Y is sulfur, X is sulfur on an imino group of the structure
- 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 then 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 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.
A method for treating a patient with a peptide or a protein, said method comprising administering to a patient in need of peptide treatment or protein treatment , a pharmaceutical composition in the form of an emulsion suitable for delivery to a mucous membrane comprising;
- a macrocyclic permeation enhancer, a liquid carrier, a hydrocolloid emulsifying agent, and a therapeutically effective amount of a pharmaceutically active agent other than insulin selected from the group consisting of peptides and proteins;
- wherein said macrocylic permeation enhancer is a Hsieh enhancer;
- said 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 of the structure ═N—R, X is an imino group of the structure
- and when Y is sulfur, X is sulfur or an imino group of the structure
- 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), then m+n is at least 11.
Dependencies are inferred from the claim text.