US2021361610A1PendingUtilityA1

Compounds containing s-n-valeryl-n-{[2'-(1h-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2r,4s)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations

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Assignee: NOVARTIS PHARMACEUTICALS CORPPriority: Nov 9, 2005Filed: Aug 5, 2021Published: Nov 25, 2021
Est. expiryNov 9, 2025(expired)· nominal 20-yr term from priority
Inventors:Lili FengSven Erik GodtfredsenPaul Allen SuttonMahavir PrashadMichael John GirgisBin HuYugang LiuThomas J. BlacklockPiotr H. Karpinski
A61P 25/00A61K 2300/00A61P 9/00A61P 9/06A61K 31/5415A61K 31/41A61K 31/4422C07D 257/04A61P 13/02C07D 207/50A61K 45/06A61K 31/216A61P 7/12A61P 13/12A61P 11/00A61P 9/04A61P 25/06A61P 3/04A61P 5/42A61P 9/14A61P 5/24C07C 233/47A61P 9/08A61P 43/00A61P 27/02A61P 3/10A61P 3/00A61P 17/00A61P 25/28A61P 9/12A61P 9/10A61P 27/06A61P 3/06
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Claims

Abstract

A compound comprising of the angiotensin receptor antagonist (ARB) valsartan, the neutral endopeptidase inhibitor (NEPi) (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methylpentanoic acid ethyl ester and one or more monovalent cations such as Na + useful for the treatment of hypertension and/or heart failure.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . An amorphous solid form of a compound consisting of anionic (S)—N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine, anionic (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester, and sodium cations in a 1:1:3 molar ratio. 
     
     
         2 . A pharmaceutical composition comprising the amorphous solid form according to  claim 1  and at least one pharmaceutically acceptable excipient. 
     
     
         3 . A pharmaceutical composition suitable for oral administration comprising solid trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3′-methyl-2′-(pentanoyl{2″-(tetrazol-5-ylate)biphenyl-4′-ylmethyl}amino)butyrate]. 
     
     
         4 . A pharmaceutical composition suitable for oral administration comprising solid amorphous trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(S)-3′-methyl-2′-(pentanoyl{2″-(tetrazol-5-ylate)biphenyl-4′-ylmethyl}amino)butyrate]. 
     
     
         5 . A tablet prepared by a process comprising combining at least one pharmaceutically acceptable excipient with a solid amorphous form of:

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