Crystalline forms of trisodium supramolecular complex comprising valsartan and AHU-377 and methods thereof
AssigneesCrystal Pharmatech Co., Ltd., Suzhou Pengxu Pharmatech Co., Ltd.
InventorsMinhua Chen, Yanfeng Zhang, Chaohui Yang, Xiaoyu Zhang, Jiaoyang Li, Peng Wang, Pixu Li
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Abstract
Novel crystalline Forms of trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butyl carbamoyl) propionate-(S)-3′-methyl-T-(pentanoyl{2″-(tetrazol-5-ylate)biphenyl-4′-ylmethyl}amino)butyrate] hydrate, methods for their preparation, pharmaceutical compositions comprising these new forms, and use of them for treating or delaying progression or onset of diseases or disorders related to activity of angiotensin receptor 1 (AT1) blockage and neprilysin (NEP) inhibition, such as heart failure, are disclosed.
Claims19
A crystalline form of 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] hydrate, designated as Form I, characterized by an X-ray powder diffraction pattern comprising the following 2θ values measured using CuKα radiation:
- 5.1°±0.2°, 13.5°±0.2°, and 14.9°±0.2°.
A crystalline form of trisodium [3-((1S,3R)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl) propionate-N-3′-methyl-2′-(pentanoyl{2″-(tetrazol-5-ylate)biphenyl-4′-ylmethyl}amino)butyrate] hydrate, designated as Form II, characterized by an X-ray powder diffraction pattern comprising the following 2θ values measured using CuKα radiation:
- 4.3°±0.2°, 10.9°±0.2°, and 14.6°±0.2°.
A crystalline form of 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] hydrate, designated as Form III, characterized by an X-ray powder diffraction pattern comprising the following 2θ values measured using CuKα radiation:
- 8.2°±0.2°, 17.2°±0.2°, and 21.5°±0.2°.
A pharmaceutical composition comprising a crystalline form of the supramolecular complex selected from the group consisting of crystalline Form I, crystalline Form II, crystalline Form III, and combinations thereof, and a pharmaceutically acceptable carrier.
Dependencies are inferred from the claim text.