Ultra-pure agonists of guanylate cyclase C, method of making and using same

US11142549B2 · US · B2

Patent metadata
FieldValue
Publication numberUS-11142549-B2
Application numberUS-202016921450-A
CountryUS
Kind codeB2
Filing dateJul 6, 2020
Priority dateJun 5, 2013
Publication dateOct 12, 2021
Grant dateOct 12, 2021

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  1. Title

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  2. Abstract

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  3. Assignees and inventors

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  4. Key dates

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  5. First independent claim

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Abstract

Official abstract text for this publication.

The invention provides processes of purifying a peptide including a GCC agonist sequence selected from the group consisting of SEQ ID NOs: 1-251 described herein. The processes include a solvent exchange step before a freeze-drying (lyophilization) step.

First claim

Opening claim text (preview).

We claim: 1. An oral formulation comprising: (a) a purified peptide comprising the Guanylate Cyclase-C(GCC) agonist of amino acid sequence of SEQ ID NO: 1, wherein the purified peptide comprises less than 0.05% trifluoroacetic acid (TFA) by weight of the purified peptide; and (b) one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprises microcrystalline cellulose. 2. The oral formulation of claim 1 , comprising 0.01 mg to 10 mg of the purified peptide. 3. The oral formulation of claim 2 , comprising 0.1 mg to 5 mg of the purified peptide. 4. The oral formulation of claim 3 , comprising 3 mg of the purified peptide. 5. The oral formulation of claim 1 , wherein the purified peptide has an average particle size of 80-120 μm. 6. The oral formulation of claim 1 , wherein the one or more pharmaceutically acceptable excipients further comprises magnesium stearate.

Assignees

Inventors

Classifications

  • Elution mode · CPC title

  • Extraction; Separation; Purification · CPC title

  • Guanylate cyclase (4.6.1.2) · CPC title

  • Lyases (4.) · CPC title

  • Peptides having 12 to 20 amino acids {(A61K38/043 - A61K38/046 take precedence)} · CPC title

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What does patent US11142549B2 cover?
The invention provides processes of purifying a peptide including a GCC agonist sequence selected from the group consisting of SEQ ID NOs: 1-251 described herein. The processes include a solvent exchange step before a freeze-drying (lyophilization) step.
Who is the assignee on this patent?
Bausch Health Ireland Ltd
What technology area does this patent fall under?
Primary CPC classification C07K7/08. Mapped technology areas include Chemistry & Metallurgy.
When was this patent published?
Publication date Tue Oct 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time) (B2). Legal status and post-grant events are not shown on this page.
What related patents are in patentsdb?
We list 1 related publication on this page (citations in our corpus or others sharing the same primary CPC).