CY1108486T1 - Μορφες δοσολογιας αζιθρομυκινης με μειωμενες παρενεργειες - Google Patents

Μορφες δοσολογιας αζιθρομυκινης με μειωμενες παρενεργειες

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Publication number
CY1108486T1
CY1108486T1 CY20081101264T CY081101264T CY1108486T1 CY 1108486 T1 CY1108486 T1 CY 1108486T1 CY 20081101264 T CY20081101264 T CY 20081101264T CY 081101264 T CY081101264 T CY 081101264T CY 1108486 T1 CY1108486 T1 CY 1108486T1
Authority
CY
Cyprus
Prior art keywords
azithromycin
glyceryl
effective amount
agent
alkalizing agent
Prior art date
Application number
CY20081101264T
Other languages
English (en)
Inventor
Leah Elizabeth Appel
Marshall David Crew
Dwayne Thomas Friesen
Timothy Arthur Hagen
Scott Max Herbig
Julian Belknap Lo
David Keith Lyon
Scott Baldwin Mccray
Avinash Govind Thombre
James Blair West
Original Assignee
Pfizer Products Incorporated
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=34468055&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CY1108486(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pfizer Products Incorporated filed Critical Pfizer Products Incorporated
Publication of CY1108486T1 publication Critical patent/CY1108486T1/el

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • A61P33/02Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis

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

Abstract

Μία μορφή δοσολογίας δια του στόματος περιλαμβάνουσα αζιθρομυκίνη και μία αποτελεσματική ποσότητα ενός παράγοντα αλκαλοποιήσεως. Κατά προτίμηση, η εν λόγω μορφή δοσολογίας δια του στόματος περιλαμβάνει μία αποτελεσματική ποσότητα ενός παράγοντα αλκαλοποιήσεως και μία πολυσωματιδιακή αζιθρομυκίνη όπου τα εν λόγω πολυσωματίδια περιλαμβάνουν αζιθρομυκίνη, ένα μίγμα μονοβεχενικού γλυκερυλίου, διβεχενικού γλυκερυλίου και τριβεχενικού γλυκερυλίου και ένα πολοξαμερές. Τυπικά, η μορφή δοσολογίας δια του στόματος περιλαμβάνει οποιοδήποτε κατάλληλο μέσο χορηγήσεως δια του στόματος όπως κόνη για στοματικό εναιώρημα, ένα πακέτο ή φακελίσκο μοναδιαίας δόσεως, ένα δισκίο ή μία κάψουλα. Αποκαλύπτεται επί πλέον ένα στοματικό εναιώρημα περιλαμβάνον αζιθρομυκίνη, μία αποτελεσματική ποσότητα ενός παράγοντα αλκαλοποιήσεως και ένα όχημα. Κατά προτίμηση, η αζιθρομυκίνη είναι σε πολυσωματιδιακή μορφή όπου η εν λόγω πολυσωματιδιακή σύνθεση περιλαμβάνει αζιθρομυκίνη, ένα μίγμα μονοβεχενικού γλυκερυλίου, διβεχενικού γλυκερυλίου και τριβεχενικού γλυκερυλίου και ένα πολοξαμερές. Αποκαλύπτεται επίσης μία μέθοδος μειώσεως των γαστρεντερικών παρενεργειών που συνδέονται με τη χορήγηση αζιθρομυκίνης σε ένα θηλαστικό, περιλαμβάνουσα τη γειτονική χορήγηση αζιθρομυκίνης και μίας αποτελεσματικής ποσότητας ενός παράγοντα αλκαλοποιήσεως στο εν λόγω θηλαστικό όπου η συχνότητα των γαστρεντερικών παρενεργειών είναι χαμηλότερη από εκείνη που παρουσιάζεται δια χορηγήσεως μίας ίσης δόσεως αζιθρομυκίνης χωρίς τον εν λόγω παράγοντα αλκαλοποιήσεως. Αποκαλύπτεται περαιτέρω μία μέθοδος αγωγής μίας βακτηριακής ή πρωτοζωικής λοιμώξεως
CY20081101264T 2003-12-04 2008-11-06 Μορφες δοσολογιας αζιθρομυκινης με μειωμενες παρενεργειες CY1108486T1 (el)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US52708403P 2003-12-04 2003-12-04
US10/763,340 US6984403B2 (en) 2003-12-04 2004-01-23 Azithromycin dosage forms with reduced side effects
EP04252643A EP1537859B1 (en) 2003-12-04 2004-05-06 Azithromycin dosage forms with reduced side effects

Publications (1)

Publication Number Publication Date
CY1108486T1 true CY1108486T1 (el) 2014-04-09

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ID=34468055

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Country Status (36)

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US (4) US6984403B2 (el)
EP (1) EP1537859B1 (el)
JP (2) JP4602711B2 (el)
KR (1) KR100906290B1 (el)
AR (1) AR045630A1 (el)
AT (1) ATE407663T1 (el)
BR (1) BRPI0403935B8 (el)
CA (1) CA2467611C (el)
CL (1) CL2004001501A1 (el)
CR (1) CR7500A (el)
CY (1) CY1108486T1 (el)
DE (1) DE602004016444D1 (el)
DK (1) DK1537859T3 (el)
DO (1) DOP2004000994A (el)
EA (1) EA010110B1 (el)
ES (1) ES2312929T3 (el)
GE (1) GEP20074056B (el)
HK (1) HK1080367B (el)
HR (1) HRP20040865A2 (el)
IL (1) IL164165A (el)
IS (1) IS2672B (el)
MA (1) MA27848A1 (el)
MX (1) MXPA04009424A (el)
NL (1) NL1026315C2 (el)
NO (1) NO20043903L (el)
NZ (1) NZ535464A (el)
OA (1) OA12858A (el)
PA (1) PA8611501A1 (el)
PE (1) PE20050573A1 (el)
PL (2) PL1537859T3 (el)
PT (1) PT1537859E (el)
RS (1) RS84704A (el)
SI (1) SI1537859T1 (el)
TW (1) TWI351969B (el)
UY (1) UY28509A1 (el)
WO (1) WO2005053650A1 (el)

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