RU2005130637A - Стерилизация лекарственных частиц беклометазона для доставки через легкие - Google Patents

Стерилизация лекарственных частиц беклометазона для доставки через легкие Download PDF

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Publication number
RU2005130637A
RU2005130637A RU2005130637/15A RU2005130637A RU2005130637A RU 2005130637 A RU2005130637 A RU 2005130637A RU 2005130637/15 A RU2005130637/15 A RU 2005130637/15A RU 2005130637 A RU2005130637 A RU 2005130637A RU 2005130637 A RU2005130637 A RU 2005130637A
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RU
Russia
Prior art keywords
sterilization
delivery
beclomethasone
mixture
beclometasone
Prior art date
Application number
RU2005130637/15A
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English (en)
Other versions
RU2336905C2 (ru
Inventor
Марко ДЖЕНТИЛЕ (IT)
Марко Джентиле
Мари Кончетта ДРАГАНИ (IT)
Мария Кончетта ДРАГАНИ
Марко ДЕЛЛ`УОМО (IT)
Марко ДЕЛЛ`УОМО
Original Assignee
Домпе С.П.А. (It)
Домпе С.П.А.
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Application filed by Домпе С.П.А. (It), Домпе С.П.А. filed Critical Домпе С.П.А. (It)
Publication of RU2005130637A publication Critical patent/RU2005130637A/ru
Application granted granted Critical
Publication of RU2336905C2 publication Critical patent/RU2336905C2/ru

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J7/00—Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of two carbon atoms
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/04—Heat
    • A61L2/06—Hot gas
    • A61L2/07—Steam
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J5/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond
    • C07J5/0007—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond not substituted in position 17 alfa
    • C07J5/0015—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond not substituted in position 17 alfa not substituted in position 16
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J5/00—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond
    • C07J5/0046—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond substituted in position 17 alfa
    • C07J5/0061—Normal steroids containing carbon, hydrogen, halogen or oxygen, substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane and substituted in position 21 by only one singly bound oxygen atom, i.e. only one oxygen bound to position 21 by a single bond substituted in position 17 alfa substituted in position 16
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J51/00—Normal steroids with unmodified cyclopenta(a)hydrophenanthrene skeleton not provided for in groups C07J1/00 - C07J43/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J75/00—Processes for the preparation of steroids in general
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)

Claims (4)

1. Способ стерилизации паром беклометазона, включающий нагревание смеси микронизированного беклометазона и воды при температуре в пределах между 100°С и 130°С в течение времени, достаточного для стерилизации смеси до минимального уровня гарантии стерильности (S.A.L.), равного 10-6, причем смесь является только смесью беклометазона и воды.
2. Способ по п.1, где беклометазон представлен в форме дипропионата беклометазона.
3. Способ по п.1 или 2, где соотношение беклометазон:вода выбирают в диапазоне между 3:100 и 10:100.
4. Способ по п.1 или 2, где стерилизацию осуществляют при температуре 121°С в течение 20 мин.
RU2005130637/15A 2003-03-04 2004-03-02 Стерилизация лекарственных частиц беклометазона для доставки через легкие RU2336905C2 (ru)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP03004726.0 2003-03-04
EP03004726A EP1454636A1 (en) 2003-03-04 2003-03-04 Sterilization of glucocorticoid drug particles for pulmonary delivery

Publications (2)

Publication Number Publication Date
RU2005130637A true RU2005130637A (ru) 2006-01-27
RU2336905C2 RU2336905C2 (ru) 2008-10-27

Family

ID=32798759

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2005130637/15A RU2336905C2 (ru) 2003-03-04 2004-03-02 Стерилизация лекарственных частиц беклометазона для доставки через легкие

Country Status (15)

Country Link
US (1) US20060140816A1 (ru)
EP (2) EP1454636A1 (ru)
JP (1) JP4712689B2 (ru)
AT (1) ATE360443T1 (ru)
BR (1) BRPI0408022B1 (ru)
CY (1) CY1106732T1 (ru)
DE (1) DE602004006089T2 (ru)
DK (1) DK1599233T3 (ru)
ES (1) ES2285436T3 (ru)
MX (1) MXPA05009348A (ru)
PL (1) PL1599233T3 (ru)
PT (1) PT1599233E (ru)
RU (1) RU2336905C2 (ru)
SI (1) SI1599233T1 (ru)
WO (1) WO2004078102A2 (ru)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2523035C (en) 2003-05-22 2011-04-26 Elan Pharma International Ltd. Sterilization of dispersions of nanoparticulate active agents with gamma radiation
PE20050941A1 (es) 2003-12-16 2005-11-08 Nycomed Gmbh Suspensiones acuosas de ciclesonida para nebulizacion
GB0410995D0 (en) 2004-05-17 2004-06-23 Norton Healthcare Ltd Heat sterilization of glucocorticosteroids
GB0425266D0 (en) * 2004-11-16 2004-12-15 Norton Healthcare Ltd Pharmaceutical manufacturing process
EP2704724B1 (en) 2011-05-03 2016-10-26 Chiesi Farmaceutici S.p.A. Improved suspension formulation of beclometasone dipropionate for administration by inhalation
JP5792240B2 (ja) * 2012-08-27 2015-10-07 武夫 西 注射シミュレータ用模擬剤及びその製造方法と製造装置
CA3006251A1 (en) * 2015-12-07 2017-06-15 Emcure Pharmaceuticals Limited Sterile parenteral suspensions

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3962430A (en) * 1974-08-07 1976-06-08 Merck & Co., Inc. Sterilization of solid non-electrolyte medicinal agents employing sodium chloride
GB9410222D0 (en) * 1994-05-21 1994-07-06 Glaxo Wellcome Australia Ltd Medicaments
SE9704186D0 (sv) * 1997-11-14 1997-11-14 Astra Ab New composition of matter
US6066292A (en) * 1997-12-19 2000-05-23 Bayer Corporation Sterilization process for pharmaceutical suspensions
EP0938896A1 (en) * 1998-01-15 1999-09-01 Novartis AG Autoclavable pharmaceutical compositions containing a chelating agent
IT1303692B1 (it) * 1998-11-03 2001-02-23 Chiesi Farma Spa Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione.
EP1337279B1 (en) * 2000-11-24 2006-06-21 Breath Limited Sterilisation of glucocorticosteriode suspensions
JP4364486B2 (ja) * 2002-07-02 2009-11-18 帝人株式会社 無菌水性懸濁製剤

Also Published As

Publication number Publication date
DE602004006089T2 (de) 2008-01-10
EP1599233A2 (en) 2005-11-30
DE602004006089D1 (de) 2007-06-06
MXPA05009348A (es) 2005-11-04
ATE360443T1 (de) 2007-05-15
PL1599233T3 (pl) 2007-10-31
EP1599233B1 (en) 2007-04-25
DK1599233T3 (da) 2007-09-17
PT1599233E (pt) 2007-07-26
JP4712689B2 (ja) 2011-06-29
ES2285436T3 (es) 2007-11-16
BRPI0408022A (pt) 2006-02-14
JP2007527364A (ja) 2007-09-27
SI1599233T1 (sl) 2007-10-31
EP1454636A1 (en) 2004-09-08
RU2336905C2 (ru) 2008-10-27
US20060140816A1 (en) 2006-06-29
BRPI0408022B1 (pt) 2018-01-23
WO2004078102A2 (en) 2004-09-16
WO2004078102A3 (en) 2004-11-18
CY1106732T1 (el) 2012-05-23

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Legal Events

Date Code Title Description
PC43 Official registration of the transfer of the exclusive right without contract for inventions

Effective date: 20151027

MM4A The patent is invalid due to non-payment of fees

Effective date: 20190303