You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 9,925,231


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 9,925,231
Title:Formulations of guanylate cyclase C agonists and methods of use
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.
Inventor(s): Comiskey; Stephen (Doylestown, PA), Feng; Rong (Langhorne, PA), Foss; John (Doylestown, PA), Shailubhai; Kunwar (Audubon, PA)
Assignee: SYNERGY PHARMACEUTICALS, INC. (New York, NY)
Application Number:15/467,631
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,925,231
Patent Claims: 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 .degree. C. and 65% relative humidity, or at least 18 months at 25 .degree. C. and 60% relative humidity, or at least 18 months at 2-8 .degree. 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.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.