SI2413924T1 - L-ornitinijev fenilacetat in metode njegove izdelave - Google Patents

L-ornitinijev fenilacetat in metode njegove izdelave Download PDF

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SI2413924T1
SI2413924T1 SI201031596T SI201031596T SI2413924T1 SI 2413924 T1 SI2413924 T1 SI 2413924T1 SI 201031596 T SI201031596 T SI 201031596T SI 201031596 T SI201031596 T SI 201031596T SI 2413924 T1 SI2413924 T1 SI 2413924T1
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preparation according
crystalline form
ppm silver
preparation
benzoic acid
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SI201031596T
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Keith Anderson
Jim Behling
Christine Henderson Dougan
Stephen William Watt
Peter Manini
Attilia Figini
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Ocera Therapeutics, Inc.
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    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38—Separation; Purification; Stabilisation; Use of additives
    • C07C227/40—Separation; Purification
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/14—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton from compounds containing already amino and carboxyl groups or derivatives thereof
    • C07C227/16—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton from compounds containing already amino and carboxyl groups or derivatives thereof by reactions not involving the amino or carboxyl groups
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/14—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton from compounds containing already amino and carboxyl groups or derivatives thereof
    • C07C227/18—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton from compounds containing already amino and carboxyl groups or derivatives thereof by reactions involving amino or carboxyl groups, e.g. hydrolysis of esters or amides, by formation of halides, salts or esters
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C227/38—Separation; Purification; Stabilisation; Use of additives
    • C07C227/40—Separation; Purification
    • C07C227/42—Crystallisation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C229/00—Compounds containing amino and carboxyl groups bound to the same carbon skeleton
    • C07C229/02—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton
    • C07C229/04—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated
    • C07C229/26—Compounds containing amino and carboxyl groups bound to the same carbon skeleton having amino and carboxyl groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being acyclic and saturated having more than one amino group bound to the carbon skeleton, e.g. lysine
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
    • C07C51/41—Preparation of salts of carboxylic acids
    • C07C51/412—Preparation of salts of carboxylic acids by conversion of the acids, their salts, esters or anhydrides with the same carboxylic acid part
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
    • C07C51/42—Separation; Purification; Stabilisation; Use of additives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C51/00—Preparation of carboxylic acids or their salts, halides or anhydrides
    • C07C51/42—Separation; Purification; Stabilisation; Use of additives
    • C07C51/43—Separation; Purification; Stabilisation; Use of additives by change of the physical state, e.g. crystallisation
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    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C57/00—Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms
    • C07C57/30—Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms containing six-membered aromatic rings
    • C07C57/32—Phenylacetic acid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C57/00—Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms
    • C07C57/46—Unsaturated compounds having carboxyl groups bound to acyclic carbon atoms containing six-membered aromatic rings and other rings, e.g. cyclohexylphenylacetic acid
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

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  • Chemical & Material Sciences (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (10)

  1. L-ORNITINIJEV FENILACETAT IN METODE NJEGOVE IZDELAVE EP 2413924 PATENTNI ZAHTEVKI
    1. Pripravek, ki vsebuje kristalinično obliko L-omitinijevega fenilacetata, značilen po tem, da kristalinična oblika kaže vzorec praškovne difrakcije z rentgenskimi žarki, ki ga sestavljajo vsaj trije značilni vrhovi, značilni po tem, da so navedeni značilni vrhovi izbrani iz skupine, ki jo sestavljajo 6,0°±0,2° 2Θ, 13,9°±0,2° 2Θ, 14,8°±0,2° 2Θ, 17,1°±0,2° 2Θ, 17,8°±0,2° 2Θ in 24,1°±0,2° 2Θ, in izbirno značilen po tem, da: (i) navedena kristalinična oblika kaže monokristalno kristalografho analizo z rentgenskimi žarki s kristalnimi parametri, ki so približno enaki naslednjim: dimenzije osnovne celice: a=6,594(2) A, b=6,5448(18) A, c=31,632(8) A, α=90ο, β=91,12(3)°, γ=90°, kristalni sistem: monoklinski in prostorska skupina: P2i, in/ali (ii) navedeno kristalinično obliko predstavlja formula [C5H13Ν2Ο2] [C8H7O2].
  2. 2. Pripravek po zahtevku 1, značilen po tem, da navedena kristalinična oblika kaže vzorec praškovne difrakcije z rentgenskimi žarki, ki ga sestavljajo značilni vrhovi pri 6,0°±0,2° 2Θ, 13,9°±0,2° 2Θ, 14,8°±0,2° 2Θ, 17,1°±0,2° 2Θ, 17,8°±0,2° 2Θ in 24,1°±0,2° 2Θ.
  3. 3. Pripravek po zahtevku 1, značilen po tem, da ima navedena kristalinična oblika tališče pri 202 °C.
  4. 4. Pripravek po katerem koli od zahtevkov 1-3, sestavljen iz: najmanj približno 50 mas. % kristalinične oblike L-omitinijevega fenilacetata in najmanj približno 0,01 mas. % benzojske kisline ali njene soli.
  5. 5. Pripravek po zahtevku 4, značilen po tem, da pripravek vsebuje: (i) najmanj približno 0,10 mas. % benzojske kisline ali njene soli in/ali (ii) največ 5 mas. % benzojske kisline ali njene soli ali največ 1 mas. % benzojske kisline ali njene soli.
  6. 6. Pripravek po zahtevku 4 ali 5, značilen po tem, da pripravek nadalje vsebuje: (i) najmanj 10 ppm srebra ali najmanj 20 ppm srebra ali najmanj 25 ppm srebra in/ali (ii) največ 600 ppm srebra ali največ 100 ppm srebra ali največ 65 ppm srebra.
  7. 7. Pripravek po katerem koli od zahtevkov 1-6, značilen po tem, da je 50 mg/ml navedenega pripravka v vodi izotoničnega s telesnimi tekočinami.
  8. 8. Pripravek po zahtevku 7, značilen po tem, da ima izotonična raztopina osmolalnost v območju približno 280 do približno 330 mOsm/kg.
  9. 9. Pripravek po katerem koli od zahtevkov 1-8 za uporabo pri zdravljenju ali izboljševanju hiperamoniemije pri subjektu.
  10. 10. Pripravek po zahtevku 9, značilen po tem, da ima subjekt jetrno encefalopatijo ali hiperamoniemijo.
SI201031596T 2009-04-03 2010-04-01 L-ornitinijev fenilacetat in metode njegove izdelave SI2413924T1 (sl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US16667609P 2009-04-03 2009-04-03
PCT/US2010/029708 WO2010115055A1 (en) 2009-04-03 2010-04-01 L-ornithine phenyl acetate and methods of making thereof
EP10759442.6A EP2413924B1 (en) 2009-04-03 2010-04-01 L-ornithine phenyl acetate and methods of making thereof

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SI2413924T1 true SI2413924T1 (sl) 2018-01-31

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US (9) US8173706B2 (sl)
EP (4) EP3686183B1 (sl)
JP (6) JP6144488B2 (sl)
KR (6) KR20220067001A (sl)
CN (3) CN104230730B (sl)
AU (1) AU2010232521B2 (sl)
BR (1) BRPI1013657A2 (sl)
CA (5) CA2998344C (sl)
CY (1) CY1119843T1 (sl)
DK (3) DK3263100T3 (sl)
EA (2) EA023051B1 (sl)
ES (3) ES2791524T3 (sl)
HK (1) HK1248558A1 (sl)
HR (2) HRP20221232T8 (sl)
HU (2) HUE035921T2 (sl)
IL (2) IL215449B (sl)
LT (2) LT2413924T (sl)
MX (3) MX2011010262A (sl)
NO (1) NO2413924T3 (sl)
NZ (3) NZ708458A (sl)
PL (2) PL3686183T3 (sl)
PT (2) PT2413924T (sl)
SG (3) SG10202010988WA (sl)
SI (1) SI2413924T1 (sl)
WO (1) WO2010115055A1 (sl)
ZA (1) ZA201107189B (sl)

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