Formulations of Guanylate Cyclase C Agonists and Methods of Use
AssigneeSynergy Pharmaceuticals, Inc.
InventorsStephen Comiskey, Rong Feng, John Foss, Kunwar Shailubhai
Life of this patent
Estimating the term…
Abstract
The invention provides low-dose formulations of guanylate cyclase-C (“GCC”) agonist peptides and methods for their use. The formulations of the invention can be administered either alone or in combination with one or more additional therapeutic agents, preferably an inhibitor of cGMP-dependent phosphodiesterase or a laxative.
Claims42
An oral dosage formulation comprising at least one GCC agonist peptide and one or more pharmaceutically acceptable excipients, wherein the amount of GCC agonist peptide per unit dose is from 0.01 mg to 10 mg, and the GCC agonist peptide is selected from the group consisting of SEQ ID NOs:
- 9 and 8.
An oral dosage formulation comprising at least one GCC agonist peptide and one or more pharmaceutically acceptable excipients, wherein the amount of GCC agonist peptide per unit dose is from 0.01 mg to 10 mg, the GCC agonist peptide is selected from the group consisting of SEQ ID NOs:
- 1-54 and 56-249, and the GCC agonist peptide has a chromatographic purity of no less than 91%.
A process for making an oral dosage formulation comprising at least one GCC agonist peptide, the method comprising:
- a) providing an aqueous solution comprising:
- a GCC agonist peptide selected from the group consisting of SEQ ID NOs:
- 1-54 and 56-249, and one or more pharmaceutically acceptable excipients, wherein the concentration of the GCC agonist peptide ranges from 10 to 60 mg/mL;
- and
- b) applying the aqueous solution to a pharmaceutically acceptable carrier to generate a GCC agonist peptide-coated carrier.
Dependencies are inferred from the claim text.