AR063469A1 - Formas polimorficas de ácido (3r,5r)-7-[2-(4-fluorofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3, 5-dihidroxi-heptanoico, sal hemicalcio, metodos de preparacion de las mismas, una composicion farmaceutica que las comprende y su uso en el tratamiento de enfermedades - Google Patents

Formas polimorficas de ácido (3r,5r)-7-[2-(4-fluorofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3, 5-dihidroxi-heptanoico, sal hemicalcio, metodos de preparacion de las mismas, una composicion farmaceutica que las comprende y su uso en el tratamiento de enfermedades

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Publication number
AR063469A1
AR063469A1 ARP070103140A ARP070103140A AR063469A1 AR 063469 A1 AR063469 A1 AR 063469A1 AR P070103140 A ARP070103140 A AR P070103140A AR P070103140 A ARP070103140 A AR P070103140A AR 063469 A1 AR063469 A1 AR 063469A1
Authority
AR
Argentina
Prior art keywords
phenyl
solution
pyrrol
dihydroxy
heptanoic
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ARP070103140A
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English (en)
Inventor
Mohammad Baqer
Vishwesh P Pandya
Gyan Chand Yadav
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Ranbaxy Lab Ltd
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38957150&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR063469(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ranbaxy Lab Ltd filed Critical Ranbaxy Lab Ltd
Publication of AR063469A1 publication Critical patent/AR063469A1/es

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/30—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D207/34—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Hematology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Obesity (AREA)
  • Rheumatology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Hospice & Palliative Care (AREA)
  • Vascular Medicine (AREA)
  • Psychiatry (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyrrole Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Formas polimorficas de un inhibidor de reductasa HMG-CoA (3R, 5R)-7-[2-(4-fluorufenil)-5- isopropil-3-fenil-4-[(4-hidroximetilfenilamino) carbonil]-pirrol-1-il]-3,5-dihidroxi-acido heptanoico, hemi sal de calcio. También comprende métodos para preparar estas formas polimorficas, formulaciones farmacéuticas que, contienen estas formas polimorficas y métodos para usar las formas polimorficas del inhibidor de reductasa HMG-CoA. Reivindicacion 1: Un polimorfo cristalino de ácido (3R,5R)-7- [2-(4-fluorofenil)-5-isopropil-3-fenil-4-[(4-hidroximetiIfenilamino)carbonil]-pirrol-1-il]-3,5-dihidroxi-heptanoico sal hemi calcio, que llene picos de difraccion de polvo de rayos X de, aproximadamente, 5,43; 7,95; 9,61; 11,29; 11,92; 18,91; 19,25; 22,78 y 23,95 2theta°. Reivindicacion 26: Un método para realizar una forma polimorfa cristalina de un inhibidor de la reductasa HMG-CoA, el cual comprende: a) disolver ácido (3R, 5R)-7-[2-(4-fluofenil)-5-isopropil 3-fenil-4-[(4- hidroximetilfenilamino)carbonil]-pirrol-1-il]-3,5-dihidroxi-heptanoico sal hemi calcio, en un solvente que comprende agua y acetato de etilo para formar una solucion; b) enfriar la solucion a menos de, aproximadamente, 30°C y c) eliminar el solvente de la solucion a los fines de recuperar un polimorfo cristalino de la Forma 1 de ácido (3R, 5R)-7-[2(4-fluofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3,5-dihidroxi- heptanoico sal hemi calcio. Reivindicacion 27: Un método para realizar una forma polimorfa cristalina de un inhibidor de la reductasa HMG-CoA, el cual comprende: a) disolver ácido (3R,5R)-7-12-(4-fluofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-iI]-3,5-dihidroxi- heptanoico sal hemi calcio, en un solvente que comprende agua y etanol para formar una solucion; b) enfriar la solucion a menos de, aproximadamente, 30°C y c) eliminar el solvente de la solucion a los fines de recuperar un polimorfo cristalino de la Forma 1 de ácido (3R,5R)-7-[2-(4-fluofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3,5-dihidroxi-heptanoico sal hemi calcio.28. Reivindicacion 28: Un método para realizar una forma polimorfa cristalina de un inhibidor de la reductasa HMG-CoA, el cual comprende: a) disolver ácido (3R,5R)-7-(2-(4-fluofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3,5-dihidroxi-heptanoico sal hemi calcio, en un solvente que comprende agua y acetato de nitrilo para formar una solucion; b) enfriar la solucion a menos de, aproximadamente, 30°C y c) eliminar el solvente de la solucion a los fines de recuperar un polimorfo cristalino de la Forma II de ácido (3R,5R)-7-[2-(4-fluofenil)-5- isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]pirrol-1 il]-3,5-dihidroxi-heptanoico sal hemi calcio. Reivindicacion 29: Un método para realizar una forma polimorfa cristalina de un inhibidor de la reductasa HMG-CoA, el cual comprende: a) disolver ácido (3R,5R)-7-[2-(4-fluofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3,5-dihidroxi-heptanoico sal hemi calcio, en agua para formar una solucion; b) enfriar la solucion a menos de, aproximadamente, 30°C y c) eliminar el solvente de la solucion a los fines de recuperar un polimorfo cristalino de la Forma III de ácido (3R,5R)-7-[2-(4-fluofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3,5-dihidroxi-heptanoico sal hemi calcio. Reivindicacion 30: Un método para realizar una forma polimorfa cristalina de un inhibidor de la reductasa HMG-CoA, el cual comprende: a) disolver ácido (3R,5R)-7-[2-(4-fluofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]- pirrol-1-il]-3,5-dihidroxi-heptanoico sal hemi calcio, en un solvente que comprende agua y acetona para formar una solucion; b) enfriar la solucion a menos de, aproximadamente, 30°C y c) eliminar el solvente de la solucion a los fines de recuperar un polimorfo cristalino de la Forma IV ácido (3R,5R)-7-[2-(4-fluofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3,5-dihidroxi-heptanoico sal hemi calcio.
ARP070103140A 2006-07-14 2007-07-13 Formas polimorficas de ácido (3r,5r)-7-[2-(4-fluorofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3, 5-dihidroxi-heptanoico, sal hemicalcio, metodos de preparacion de las mismas, una composicion farmaceutica que las comprende y su uso en el tratamiento de enfermedades AR063469A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN1629DE2006 2006-07-14

Publications (1)

Publication Number Publication Date
AR063469A1 true AR063469A1 (es) 2009-01-28

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ID=38957150

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP070103140A AR063469A1 (es) 2006-07-14 2007-07-13 Formas polimorficas de ácido (3r,5r)-7-[2-(4-fluorofenil)-5-isopropil-3-fenil-4-[(4-hidroximetilfenilamino)carbonil]-pirrol-1-il]-3, 5-dihidroxi-heptanoico, sal hemicalcio, metodos de preparacion de las mismas, una composicion farmaceutica que las comprende y su uso en el tratamiento de enfermedades

Country Status (12)

Country Link
US (1) US20080153896A1 (es)
EP (1) EP2049102A4 (es)
JP (1) JP2009543773A (es)
CN (1) CN101494980A (es)
AR (1) AR063469A1 (es)
AU (1) AU2007274724B2 (es)
BR (1) BRPI0714361A2 (es)
CL (1) CL2007002044A1 (es)
MX (1) MX2009000439A (es)
RU (1) RU2009105089A (es)
TW (1) TW200811101A (es)
WO (1) WO2008010087A2 (es)

Families Citing this family (5)

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KR20110117731A (ko) * 2003-05-30 2011-10-27 랜박시 래보러터리스 리미티드 치환된 피롤 유도체와 ｈｍｇ―ｃｏ 억제제로서의 이의 용도
AU2006313430B2 (en) * 2005-11-08 2012-09-06 Ranbaxy Laboratories Limited Process for (3R,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4- [(4-hydroxy methyl phenyl amino) carbonyl]-pyrrol-1-yl]-3, 5-dihydroxy-heptanoic acid hemi calcium salt
WO2008020314A2 (en) * 2006-03-14 2008-02-21 Ranbaxy Laboratories Limited Statin stabilizing dosage formulations
KR102013157B1 (ko) * 2015-03-31 2019-08-23 대원제약주식회사 결정형 및 이의 제조방법
KR102218320B1 (ko) * 2019-07-12 2021-02-23 대원제약주식회사 (3r,5r)-7-(2-(4-플루오로페닐)-5-이소프로필-3-페닐-4-((4-히드록시메틸페닐아미노)카보닐)-피롤-1-일)-3,5-디히드록시 헵탄산 헤미칼슘염의 제조방법, 및 이에 사용되는 중간체의 제조방법

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EP2049102A4 (en) 2010-12-22
JP2009543773A (ja) 2009-12-10
TW200811101A (en) 2008-03-01
CN101494980A (zh) 2009-07-29
AU2007274724A1 (en) 2008-01-24
CL2007002044A1 (es) 2008-06-13
RU2009105089A (ru) 2010-08-27
BRPI0714361A2 (pt) 2013-03-26
EP2049102A2 (en) 2009-04-22
AU2007274724B2 (en) 2012-07-26

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