DK1869035T4 - Hidtil ukendt krystallinsk form af tiotropiumbromid og fremgangsmåde til fremstilling deraf - Google Patents

Hidtil ukendt krystallinsk form af tiotropiumbromid og fremgangsmåde til fremstilling deraf Download PDF

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Publication number
DK1869035T4
DK1869035T4 DK06847887.4T DK06847887T DK1869035T4 DK 1869035 T4 DK1869035 T4 DK 1869035T4 DK 06847887 T DK06847887 T DK 06847887T DK 1869035 T4 DK1869035 T4 DK 1869035T4
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tiotropium bromide
solution
hours
crystalline
suspension
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DK06847887.4T
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English (en)
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DK1869035T3 (da
Inventor
Nicola Diulgheroff
Alessandro Pontiroli
Francesca Scarpitta
Adrienne Kovacsne-Mezei
Judith Aronhime
Alexandr Jegorov
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Sicor Inc
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D451/00—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof
    • C07D451/02—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof
    • C07D451/04—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof with hetero atoms directly attached in position 3 of the 8-azabicyclo [3.2.1] octane or in position 7 of the 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring system
    • C07D451/06—Oxygen atoms
    • C07D451/12—Oxygen atoms acylated by aromatic or heteroaromatic carboxylic acids, e.g. cocaine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D451/00—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof
    • C07D451/02—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof
    • C07D451/04—Heterocyclic compounds containing 8-azabicyclo [3.2.1] octane, 9-azabicyclo [3.3.1] nonane, or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane or granatane alkaloids, scopolamine; Cyclic acetals thereof containing not further condensed 8-azabicyclo [3.2.1] octane or 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring systems, e.g. tropane; Cyclic acetals thereof with hetero atoms directly attached in position 3 of the 8-azabicyclo [3.2.1] octane or in position 7 of the 3-oxa-9-azatricyclo [3.3.1.0<2,4>] nonane ring system
    • C07D451/06—Oxygen atoms
    • C07D451/10—Oxygen atoms acylated by aliphatic or araliphatic carboxylic acids, e.g. atropine, scopolamine

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pulmonology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Emergency Medicine (AREA)
  • Epidemiology (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Claims (11)

1. Krystallinsk tiotropiumbromid, der er kendetegnet ved et pulver-røntgendiffraktionsmønster med toppe ved 20.2, 26.5, 28.0 og 31.2 ± 0.2 grader 2-theta og yderligere kendetegnet ved et pulver-røntgendiffraktionsmønster som vist nedenfor:
2. Krystallinsk tiotropiumbromid ifølge krav 1, der yderligere er kendetegnet ved et pulverrøntgendiffraktionsmønster med toppe ved 8.9, 15.6, 17.7, 21.7, 23.4 og 24.3 ± 0.2 grader 2-theta.
3. Krystallinsk tiotropiumbromid ifølge et hvilket som helst af ovennævnte krav, der yderligere er kendetegnet ved vægttab på < 0,1 % ved TGA.
4. Krystallinsk tiotropiumbromid ifølge et hvilket som helst af ovennævnte krav, der yderligere er kendetegnet ved et DSC-termogram med en endotermisk top ved 227 °C.
5. Krystallinsk form af tiotropiumbromid ifølge et hvilket som helst af kravene 1-4, hvor formen af tiotropiumbromid indeholder ikke mere end 10 % af en hvilken som helst anden form af tiotropiumbromid.
6. Tiotropiumbromid ifølge krav 5, hvor formen af tiotropiumbromid indeholder ikke mere end 5 % af en hvilken som helst anden form af tiotropiumbromid.
7. Tiotropiumbromid ifølge et hvilket som helst af kravene 1-4, hvor formen af tiotropiumbromid indeholder ikke mere end 10 % af tiotropiumbromid-monohydrat.
8. Tiotropiumbromid ifølge krav 7, hvor en hvilken som helst af formerne af tiotropiumbromid indeholder ikke mere end 5 % af tiotropiumbromid-monohydrat.
9. Mikroniseret tiotropiumbromid ifølge et hvilket som helst af kravene 1 til 4.
10. Farmaceutisk formulering, der omfatter tiotropiumbromid ifølge et hvilket som helst af kravene 1-9 og et farmaceutisk acceptabelt hjælpestof.
11. Anvendelse af krystallinsk tiotropiumbromid ifølge et hvilket som helst af kravene 1-8 eller mikroniseret tiotropiumbromid ifølge krav 9 til fremstilling af farmaceutiske formuleringer.
DK06847887.4T 2005-12-19 2006-12-19 Hidtil ukendt krystallinsk form af tiotropiumbromid og fremgangsmåde til fremstilling deraf DK1869035T4 (da)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US75267205P 2005-12-19 2005-12-19
US75453005P 2005-12-27 2005-12-27
US76143706P 2006-01-23 2006-01-23
US77405106P 2006-02-15 2006-02-15
US78031006P 2006-03-07 2006-03-07
US83218906P 2006-07-20 2006-07-20
US85122306P 2006-10-12 2006-10-12
US85274006P 2006-10-18 2006-10-18
PCT/US2006/048734 WO2007075858A2 (en) 2005-12-19 2006-12-19 Novel forms of tiotropium bromide and processes for preparation thereof

Publications (2)

Publication Number Publication Date
DK1869035T3 DK1869035T3 (da) 2013-01-14
DK1869035T4 true DK1869035T4 (da) 2015-11-16

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DK06847887.4T DK1869035T4 (da) 2005-12-19 2006-12-19 Hidtil ukendt krystallinsk form af tiotropiumbromid og fremgangsmåde til fremstilling deraf

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US (4) US8163913B2 (da)
EP (2) EP2123650B1 (da)
JP (3) JP5086267B2 (da)
KR (1) KR101395881B1 (da)
CN (1) CN102731494A (da)
AT (1) ATE552256T1 (da)
BR (1) BRPI0608427A2 (da)
CA (1) CA2627729A1 (da)
DK (1) DK1869035T4 (da)
ES (2) ES2396978T5 (da)
IL (1) IL187947A0 (da)
MX (1) MX2007009988A (da)
PL (2) PL1869035T5 (da)
PT (1) PT1869035E (da)
RS (1) RS52663B2 (da)
TW (1) TW200732340A (da)
WO (1) WO2007075858A2 (da)

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US8846926B2 (en) 2014-09-30
PL2123650T3 (pl) 2012-09-28
US8163913B2 (en) 2012-04-24
EP2123650A1 (en) 2009-11-25
ES2384486T3 (es) 2012-07-05
ES2396978T5 (es) 2015-12-04
MX2007009988A (es) 2008-02-22
JP5567610B2 (ja) 2014-08-06
RS52663B (en) 2013-06-28
EP2123650B1 (en) 2012-04-04
US20120108625A1 (en) 2012-05-03
JP2012136538A (ja) 2012-07-19
KR20080078779A (ko) 2008-08-28
US20140057935A1 (en) 2014-02-27
US20120165364A1 (en) 2012-06-28
CA2627729A1 (en) 2007-07-05
WO2007075858A3 (en) 2007-11-01
IL187947A0 (en) 2008-03-20
EP1869035A2 (en) 2007-12-26
JP2012176975A (ja) 2012-09-13
WO2007075858A2 (en) 2007-07-05
EP1869035B2 (en) 2015-08-12
ATE552256T1 (de) 2012-04-15
PL1869035T5 (pl) 2016-01-29
ES2396978T3 (es) 2013-03-01
TW200732340A (en) 2007-09-01
PL1869035T3 (pl) 2013-04-30
DK1869035T3 (da) 2013-01-14
US20070225314A1 (en) 2007-09-27
KR101395881B1 (ko) 2014-05-21
EP1869035B1 (en) 2012-10-03
CN102731494A (zh) 2012-10-17
PT1869035E (pt) 2013-01-10
JP2009513675A (ja) 2009-04-02
RS52663B2 (sr) 2018-05-31
BRPI0608427A2 (pt) 2009-12-29
JP5086267B2 (ja) 2012-11-28

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