MA62096B1 - Composition ophtalmique contenant de la lévofloxacine et du kétorolac, son procédé de préparation et son utilisation - Google Patents

Composition ophtalmique contenant de la lévofloxacine et du kétorolac, son procédé de préparation et son utilisation

Info

Publication number
MA62096B1
MA62096B1 MA62096A MA62096A MA62096B1 MA 62096 B1 MA62096 B1 MA 62096B1 MA 62096 A MA62096 A MA 62096A MA 62096 A MA62096 A MA 62096A MA 62096 B1 MA62096 B1 MA 62096B1
Authority
MA
Morocco
Prior art keywords
active ingredient
ketorolac
weight
volume
composition containing
Prior art date
Application number
MA62096A
Other languages
English (en)
Inventor
Luciano Marcelloni
Federico BERTOCCHI
Ioanna Rassia
George Chalkias
Konstantinos CHATZELLIS
Efrosini FOSTIERI
Original Assignee
Ntc S.R.L.
Rafarm Uk Limited
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 Ntc S.R.L., Rafarm Uk Limited filed Critical Ntc S.R.L.
Publication of MA62096B1 publication Critical patent/MA62096B1/fr

Links

Classifications

    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/08—Solutions
    • 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
    • A61P27/02—Ophthalmic agents
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une composition pharmaceutique stable au stockage pour une administration ophtalmique sous la forme d'une solution aqueuse comprenant une quantité thérapeutiquement efficace d'antibiotique lévofloxacine ou d'un sel ou dérivé pharmaceutiquement acceptable de celui-ci, en tant que premier ingrédient actif, et une quantité thérapeutiquement efficace d'anti-inflammatoire et analgésique non stéroïdien Kétorolac ou d'un sel ou dérivé pharmaceutiquement acceptable de celui-ci, en tant que second ingrédient actif, ledit premier ingrédient actif représentant environ 0,4 à environ 0,9 % en poids/volume et ledit second ingrédient actif représentant environ 0,4 à environ 0,9 % en poids/volume, les pourcentages poids/volume étant exprimés en unités g/100 ml, afin de prévenir la formation d'une couche de mousse.
MA62096A 2020-11-09 2021-11-08 Composition ophtalmique contenant de la lévofloxacine et du kétorolac, son procédé de préparation et son utilisation MA62096B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT102020000026690A IT202000026690A1 (it) 2020-11-09 2020-11-09 Composizione oftalmica contenente levofloxacina e ketorolac, metodo di preparazione e suo utilizzo
PCT/EP2021/080870 WO2022096702A1 (fr) 2020-11-09 2021-11-08 Composition ophtalmique contenant de la lévofloxacine et du kétorolac, son procédé de préparation et son utilisation
EP21810296.0A EP4240364B1 (fr) 2020-11-09 2021-11-08 Composition ophtalmique contenant de la lévofloxacine et du kétorolac, son procédé de préparation et son utilisation

Publications (1)

Publication Number Publication Date
MA62096B1 true MA62096B1 (fr) 2026-01-30

Family

ID=74669235

Family Applications (1)

Application Number Title Priority Date Filing Date
MA62096A MA62096B1 (fr) 2020-11-09 2021-11-08 Composition ophtalmique contenant de la lévofloxacine et du kétorolac, son procédé de préparation et son utilisation

Country Status (16)

Country Link
US (1) US20240000793A1 (fr)
EP (1) EP4240364B1 (fr)
KR (1) KR20230107624A (fr)
CN (1) CN116847826A (fr)
AU (1) AU2021375352A1 (fr)
CA (1) CA3197797A1 (fr)
DK (1) DK4240364T3 (fr)
HR (1) HRP20260185T1 (fr)
IL (1) IL302752A (fr)
IT (1) IT202000026690A1 (fr)
LT (1) LT4240364T (fr)
MA (1) MA62096B1 (fr)
MX (1) MX2023005409A (fr)
PT (1) PT4240364T (fr)
WO (1) WO2022096702A1 (fr)
ZA (1) ZA202306096B (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026003055A1 (fr) 2024-06-27 2026-01-02 Ntc S.R.L. Composition ophtalmique destinée à être utilisée dans la prévention et le traitement d'infections et d'inflammations oculaires

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19729879C2 (de) * 1997-07-11 1999-07-08 Mann Gerhard Chem Pharm Fab Lagerstabile ophthalmische Zusammensetzungen, umfassend Diclofenac und Ofloxacin
US6552020B1 (en) * 1999-07-30 2003-04-22 Allergan, Inc. Compositions including antibiotics and methods for using same
US6166012A (en) * 1999-07-30 2000-12-26 Allergan Sales, Inc. Antibiotic compositions and method for using same
WO2005101982A2 (fr) * 2004-03-24 2005-11-03 Sun Pharmaceutical Industries Limited Composition ophtalmique stable
EP3216451B1 (fr) * 2014-11-07 2022-04-13 Santen Pharmaceutical Co., Ltd. Composition ophtalmique aqueuse
WO2017041142A1 (fr) * 2015-09-11 2017-03-16 Polyactiva Pty Ltd Conjugué de polymère comprenant un agent bioactif

Also Published As

Publication number Publication date
LT4240364T (lt) 2026-02-10
CN116847826A (zh) 2023-10-03
WO2022096702A1 (fr) 2022-05-12
PT4240364T (pt) 2026-01-19
AU2021375352A9 (en) 2024-07-11
US20240000793A1 (en) 2024-01-04
IL302752A (en) 2023-07-01
HRP20260185T1 (hr) 2026-03-27
KR20230107624A (ko) 2023-07-17
EP4240364B1 (fr) 2025-12-31
DK4240364T3 (da) 2026-02-09
EP4240364A1 (fr) 2023-09-13
IT202000026690A1 (it) 2022-05-09
ZA202306096B (en) 2025-04-30
MX2023005409A (es) 2023-07-25
AU2021375352A1 (en) 2023-06-29
CA3197797A1 (fr) 2022-05-12

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