Granted Patent B2

US 9,925,231 · App. 15/467,631 · Granted Mar 27, 2018

Abstract

Claims (12)

1. An oral dosage formulation of a Guanylate Cyclase-C (GCC) agonist peptide consisting of SEQ ID NO:1, wherein said peptide is a (4,12; 7,15) bicycle, an inert low moisture carrier and a lubricant, wherein the peptide has a chromatographic purity of no less than 91% after storage for at least three months.

2. The oral dosage formulation of claim 1 , wherein the GCC agonist peptide has a chromatographic purity of no less than 92% to 95%.

3. The oral dosage formulation of claim 1 , wherein the formulation contains less than 0.2% inorganic acids and carboxylic acids.

4. The oral dosage formulation of claim 1 , wherein the formulation is a solid formulation and the unit dose is a powder, granule, sachet, troche, tablet, or capsule.

5. The oral dosage formulation of claim 1 , wherein the GCC agonist peptide is stabilized against degradation for a period of at least 18 months at 30 ° C. and 65% relative humidity, or at least 18 months at 25 ° C. and 60% relative humidity, or at least 18 months at 2-8 ° C.

6. The oral dosage formulation of claim 1 , wherein the formulation is in the form of a capsule or tablet.

7. The oral dosage formulation of claim 6 , wherein the capsule or tablet is in a blister pack or strip.

8. The oral dosage formulation of claim 1 , wherein the lubricant is magnesium stearate.

9. The oral dosage formulation of claim 1 , wherein the lubricant is at 0.25% (w/w).

10. The oral dosage formulation of claim 1 , wherein the inert carrier is microcrystalline cellulose.

11. The oral dosage formulation of claim 1 , wherein the inert carrier is at least 96% (w/w).

12. The oral dosage formulation of claim 1 , wherein the inert carrier has a particle size of from 50 to 900 microns.

Assignments (12)