Ultra-pure agonists of guanylate cyclase C, method of making and using same
US-10745441-B2 · Aug 18, 2020 · US
US11142549B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-11142549-B2 |
| Application number | US-202016921450-A |
| Country | US |
| Kind code | B2 |
| Filing date | Jul 6, 2020 |
| Priority date | Jun 5, 2013 |
| Publication date | Oct 12, 2021 |
| Grant date | Oct 12, 2021 |
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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.
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.
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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