CY1123162T1 - Ελεγχομενης αποδεσμευσης φαρμακευτικα σκευασματα νιταζοξανιδης - Google Patents

Ελεγχομενης αποδεσμευσης φαρμακευτικα σκευασματα νιταζοξανιδης

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Publication number
CY1123162T1
CY1123162T1 CY20201100626T CY201100626T CY1123162T1 CY 1123162 T1 CY1123162 T1 CY 1123162T1 CY 20201100626 T CY20201100626 T CY 20201100626T CY 201100626 T CY201100626 T CY 201100626T CY 1123162 T1 CY1123162 T1 CY 1123162T1
Authority
CY
Cyprus
Prior art keywords
nitazoxanide
controlled
release
pharmaceutical formulations
analog
Prior art date
Application number
CY20201100626T
Other languages
English (en)
Inventor
Jean Francois Rossignol
Marc Ayers
Original Assignee
Romark Laboratories, L.C.
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
Application filed by Romark Laboratories, L.C. filed Critical Romark Laboratories, L.C.
Publication of CY1123162T1 publication Critical patent/CY1123162T1/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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425Thiazoles
    • A61K31/4261,3-Thiazoles
    • 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
    • A61K31/7056Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing five-membered rings with nitrogen as a ring hetero atom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/21Interferons [IFN]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Virology (AREA)
  • Rheumatology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Nitrogen And Oxygen As The Only Ring Hetero Atoms (AREA)

Abstract

Παρέχονται στερεά δοσολογικά σκευάσματα νιταζοξανίδης, ή ενός αναλόγου νιταζοξανίδης, τα οποία περιλαμβάνουν ένα τμήμα ελεγχόμενης αποδέσμευσης και ένα τμήμα άμεσης αποδέσμευσης. Η φαρμακευτική σύνθεση έχει τυπικά τη μορφή μιας διστρωματικής στερεής από του στόματος δοσολογικής μορφής που περιλαμβάνει (α) ένα πρώτο στρώμα που περιλαμβάνει μια πρώτη ποσότητα νιταζοξανίδης, ή ενός αναλόγου αυτής, σε ένα σκεύασμα ελεγχόμενης αποδέσμευσης• και (β) ένα δεύτερο στρώμα που περιλαμβάνει μια δεύτερη ποσότητα νιταζοξανίδης, ή ενός αναλόγου αυτής, σε ένα σκεύασμα άμεσης αποδέσμευσης. Επίσης παρέχεται μια μέθοδος χρήσης των σκευασμάτων στην αντιμετώπιση της ηπατίτιδας C.
CY20201100626T 2009-02-13 2020-07-07 Ελεγχομενης αποδεσμευσης φαρμακευτικα σκευασματα νιταζοξανιδης CY1123162T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US20228509P 2009-02-13 2009-02-13
PCT/US2010/024000 WO2010093854A1 (en) 2009-02-13 2010-02-12 Controlled release pharmaceutical formulations of nitazoxanide

Publications (1)

Publication Number Publication Date
CY1123162T1 true CY1123162T1 (el) 2021-10-29

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
CY20201100626T CY1123162T1 (el) 2009-02-13 2020-07-07 Ελεγχομενης αποδεσμευσης φαρμακευτικα σκευασματα νιταζοξανιδης

Country Status (23)

Country Link
US (5) US8524278B2 (el)
EP (1) EP2395840B1 (el)
JP (3) JP5726766B2 (el)
KR (1) KR101697800B1 (el)
CN (2) CN102395276A (el)
AU (3) AU2010213678B2 (el)
BR (1) BRPI1007945C8 (el)
CA (1) CA2752233C (el)
CO (1) CO6501159A2 (el)
CY (1) CY1123162T1 (el)
DK (1) DK2395840T3 (el)
EA (1) EA029018B1 (el)
ES (1) ES2797493T3 (el)
HR (1) HRP20201055T1 (el)
HU (1) HUE049501T2 (el)
IL (1) IL214624A0 (el)
LT (1) LT2395840T (el)
MX (1) MX348282B (el)
PL (1) PL2395840T3 (el)
PT (1) PT2395840T (el)
SI (1) SI2395840T1 (el)
UA (1) UA107564C2 (el)
WO (1) WO2010093854A1 (el)

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UA107564C2 (uk) 2015-01-26
US20180085353A1 (en) 2018-03-29
SI2395840T1 (sl) 2020-08-31
JP2015143258A (ja) 2015-08-06
EA201190127A1 (ru) 2012-03-30
AU2016200971A1 (en) 2016-03-03
JP2012518002A (ja) 2012-08-09
US9351937B2 (en) 2016-05-31
BRPI1007945A2 (pt) 2015-09-01
EP2395840A1 (en) 2011-12-21
CO6501159A2 (es) 2012-08-15
EA029018B1 (ru) 2018-01-31
EP2395840A4 (en) 2013-12-25
AU2010213678B2 (en) 2015-11-26
US20160243087A1 (en) 2016-08-25
ES2797493T3 (es) 2020-12-02
BRPI1007945C8 (pt) 2021-05-25
BRPI1007945B1 (pt) 2020-08-04
HRP20201055T1 (hr) 2020-10-30
PL2395840T3 (pl) 2020-09-07
JP6491174B2 (ja) 2019-03-27
JP6117845B2 (ja) 2017-04-19
MX348282B (es) 2017-06-05
AU2017203148B2 (en) 2018-08-09
KR101697800B1 (ko) 2017-01-18
US20140065215A1 (en) 2014-03-06
AU2010213678A1 (en) 2011-09-01
EP2395840B1 (en) 2020-04-15
JP2017061561A (ja) 2017-03-30
CA2752233C (en) 2017-01-03
CN107260695A (zh) 2017-10-20
WO2010093854A1 (en) 2010-08-19
PT2395840T (pt) 2020-07-06
BRPI1007945C1 (pt) 2020-09-01
US10383855B2 (en) 2019-08-20
AU2017203148A1 (en) 2017-06-01
US8524278B2 (en) 2013-09-03
CA2752233A1 (en) 2010-08-19
MX2011008530A (es) 2011-10-14
LT2395840T (lt) 2020-07-10
US20190321338A1 (en) 2019-10-24
AU2016200971B2 (en) 2017-02-23
KR20120008024A (ko) 2012-01-25
US9827227B2 (en) 2017-11-28
HUE049501T2 (hu) 2020-09-28
US20100209505A1 (en) 2010-08-19
US11426388B2 (en) 2022-08-30
BRPI1007945B8 (pt) 2020-08-18
DK2395840T3 (da) 2020-06-08
JP5726766B2 (ja) 2015-06-03
IL214624A0 (en) 2011-09-27
CN102395276A (zh) 2012-03-28

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