AR013765A1 - Proceso para la esterilizacion de un glucocorticoesteroide - Google Patents

Proceso para la esterilizacion de un glucocorticoesteroide

Info

Publication number
AR013765A1
AR013765A1 ARP980105761A ARP980105761A AR013765A1 AR 013765 A1 AR013765 A1 AR 013765A1 AR P980105761 A ARP980105761 A AR P980105761A AR P980105761 A ARP980105761 A AR P980105761A AR 013765 A1 AR013765 A1 AR 013765A1
Authority
AR
Argentina
Prior art keywords
sterilization
sterile
glucocorticoid
glucocorticoids
suspensions
Prior art date
Application number
ARP980105761A
Other languages
English (en)
Original Assignee
Astra Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=20408992&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR013765(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Astra Ab filed Critical Astra Ab
Publication of AR013765A1 publication Critical patent/AR013765A1/es

Links

Classifications

    • 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
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K9/0043—Nose
    • 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
    • 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
    • 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
    • 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
    • A61P11/02—Nasal agents, e.g. decongestants
    • 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
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/44—Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Pain & Pain Management (AREA)
  • Immunology (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Saccharide Compounds (AREA)

Abstract

Un glucocorticoesteroide terapéuticamente activo que es estéril de acuerdo con la US Pharmacopoeia 23/NF18 (Norma 23/NF 18 de la Farmacopea de los EstadosUnidos). Un procedimiento para la esterilizacion de una forma en polvo de un glucocorticoesteroide, formulaciones estériles que contienenglucocorticoesteroides y el uso de los mismos para la elaboracion de un medicamento para el tratamiento de un trastorno alérgico y/o inflamatorio de lanariz o los pulmones. El procedimientoresulta adecuado y ventajoso para efectuar la esterilizacion terminal de las formulaciones farmacéuticas, porejemplo en las suspensiones de glucocorticoesteroides con respecto a la filtracio estéril y a la eterilizacion con calorhumedo. La f iltracion estérilresulta insatisfactoria debido a que tales suspensiones no pueden ser esterilizadas normalmente, puesto que la mayoría de las partículas delglucocorticoesteroide quedan retenidas en el filtro. También resultains atisfactoria la esterilizacion con calor humedo, por ejemplo el tratamientocon vapor de los frascos de vidrio que contienen el producto, debido a que tiende a producir un cambio inadmisible en el tamano de la partícula. Elpresenteprocedimiento de esterilizacion de glucocorticoesteroides secos es además ventajoso porque se puede llevar a cabo a una temperaturaconsiderablemente más baja que la considerada necesaria para la esterilizacion térmica de otras sustancias, yporque dichos gluc ocorticoesteroides estérilesse pueden utilizar en la preparacion de formulaciones estériles que los contengan.
ARP980105761A 1997-11-14 1998-11-13 Proceso para la esterilizacion de un glucocorticoesteroide AR013765A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
SE9704186A SE9704186D0 (sv) 1997-11-14 1997-11-14 New composition of matter

Publications (1)

Publication Number Publication Date
AR013765A1 true AR013765A1 (es) 2001-01-10

Family

ID=20408992

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP980105761A AR013765A1 (es) 1997-11-14 1998-11-13 Proceso para la esterilizacion de un glucocorticoesteroide

Country Status (24)

Country Link
US (3) US6392036B1 (es)
EP (1) EP1032396B1 (es)
JP (2) JP4598268B2 (es)
KR (1) KR100571075B1 (es)
CN (1) CN1173702C (es)
AR (1) AR013765A1 (es)
AT (1) ATE259642T1 (es)
AU (1) AU744992B2 (es)
BR (1) BR9814118A (es)
CA (1) CA2310222C (es)
DE (1) DE69821796T2 (es)
DK (1) DK1032396T3 (es)
ES (1) ES2214749T3 (es)
HK (1) HK1030549A1 (es)
IL (1) IL136086A (es)
MY (1) MY118856A (es)
NO (1) NO327391B1 (es)
NZ (1) NZ504273A (es)
PT (1) PT1032396E (es)
SA (1) SA99190966B1 (es)
SE (1) SE9704186D0 (es)
TW (1) TWI242436B (es)
WO (1) WO1999025359A1 (es)
ZA (1) ZA9810217B (es)

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CA2310222C (en) 2008-05-13
IL136086A0 (en) 2001-05-20
NZ504273A (en) 2002-10-25
JP4598268B2 (ja) 2010-12-15
EP1032396A1 (en) 2000-09-06
IL136086A (en) 2005-05-17
CN1173702C (zh) 2004-11-03
DK1032396T3 (da) 2004-05-24
DE69821796D1 (de) 2004-03-25
JP2010070567A (ja) 2010-04-02
US20020065256A1 (en) 2002-05-30
KR20010032088A (ko) 2001-04-16
JP2001523638A (ja) 2001-11-27
PT1032396E (pt) 2004-06-30
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