EP0338062A1 - Drug comprising the association of polymyxin b, tobramycin and amphotericin b administered by spraying - Google Patents

Drug comprising the association of polymyxin b, tobramycin and amphotericin b administered by spraying

Info

Publication number
EP0338062A1
EP0338062A1 EP19880909559 EP88909559A EP0338062A1 EP 0338062 A1 EP0338062 A1 EP 0338062A1 EP 19880909559 EP19880909559 EP 19880909559 EP 88909559 A EP88909559 A EP 88909559A EP 0338062 A1 EP0338062 A1 EP 0338062A1
Authority
EP
European Patent Office
Prior art keywords
administered
precise
amphotericin
polymyxin
tobramycin
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
EP19880909559
Other languages
German (de)
French (fr)
Inventor
Louis Lefevre-Utile
Xavier Labayle
Nicole Tenaillon
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MEDIPRO Sarl
Original Assignee
MEDIPRO Sarl
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 MEDIPRO Sarl filed Critical MEDIPRO Sarl
Publication of EP0338062A1 publication Critical patent/EP0338062A1/en
Ceased legal-status Critical Current

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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin

Definitions

  • the present invention relates to a spray medication intended to prevent the risks of infection in patients at risk by decontaminating the nasal and oropharyngeal cavities.
  • Gram-negative bacillus infections and yeast infections are common in at-risk patients. They cause significant morbidity, they are one of the main causes of the death of these patients, they increase health expenditure by increasing the length of hospital stay.
  • the present invention overcomes this drawback. It includes the combination of three antibiotics administered by spraying into the nasal and oropharyngeal cavities.
  • the three antibiotics associated in the preparation are polymyxin B, tobramycin and amphotericin B.
  • the preparation must adhere to the nasal and oral mucous membranes, slowly release the antibiotics and have a surface tension allowing maximum spreading on the mucous membranes nasal and oropharyngeal.
  • the preparation is administered by precise spraying either in the form of a pressurized aerosol dispensed by a continuous or metering valve or in the form of a nebulization dispensed by a precise pump.
  • Two pushers are supplied with each bottle: one with a long and fine cannula allowing the introduction through the nostrils and the vaporization of the nasal passages, the other with a cannula allowing a broad vaporization of the oropharyngeal cavity .
  • the doses dispensed by the valves or pumps will be very precise. They are of course a function of the concentration of antibiotics in the preparation.
  • the frequency of applications also depends on the concentration of these products.
  • valve or pump must be adapted to deliver 0.5 ml each time it is pressed.
  • 400 mg of polymyxin B, 360 mg of tobramycin and 2000 mg of amphotericin B are administered daily.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un médicament destiné à prévenir les infections à bacilles gram négatif et les mycoses chez les patients à risques. Il comporte l'association de trois antibiotiques: polymyxine B, tobramycine, amphotéricine B, administrée par vaporisation précise dans les cavités nasales et oropharyngées soit sous formed'aérosol pressurisé distribué par une valve continue ou doseuse soit sous forme de nébulisation distribuée par une pompe précise. Deux poussoirs sont fournis avec chaque flacon: l'un disposant d'une canule longue et fine permettant l'introduction par les narines et la vaporisation des fosses nasales, l'autre d'une canule permettant la vaporisation large de la cavité oropharyngée. Le médicament a des indications très larges chez tous les patients qui risquent une infection à bacilles gram négatif ou une mycose.The invention relates to a medicament for preventing gram-negative bacilli infections and yeast infections in at-risk patients. It includes the combination of three antibiotics: polymyxin B, tobramycin, amphotericin B, administered by precise spraying into the nasal and oropharyngeal cavities either in the form of pressurized aerosol distributed by a continuous or metering valve or in the form of nebulization distributed by a precise pump . Two pushers are supplied with each bottle: one with a long and fine cannula allowing the introduction through the nostrils and vaporization of the nasal cavities, the other with a cannula allowing the broad vaporization of the oropharyngeal cavity. The drug has very broad indications in all patients who are at risk for gram-negative bacillus infection or yeast infection.

Description

d d
Médicament comprenant l'association de polymyxine B, de tobramycine et d'amphotéricine B administré par vaporisation.Medicine comprising the combination of polymyxin B, tobramycin and amphotericin B administered by spraying.
La présente invention concerne un médicament pour vaporisation destiné à prévenir les risques d'infection chez les malades à risques en déconta- minant les cavités nasales et oropharyngées.The present invention relates to a spray medication intended to prevent the risks of infection in patients at risk by decontaminating the nasal and oropharyngeal cavities.
Les infections à bacilles gram négatif et les mycoses sont fréquentes chez les malades à risques. Elles entraînent une morbidité importante, elles sont une des causes principales du décès de ces patients, elles aug¬ mentent les dépenses de santé en augmentant les durées d'hospitalisation. La présente invention permet de remédier à cet inconvénient. Elle com¬ porte l'association de trois antibiotiques administrés par vaporisation dans les cavités nasales et oropharyngées. Les trois antibiotiques asso¬ ciés dans la préparation sont la polymyxine B, la tobramycine et l'ampho- téricine B. La préparation doit adhérer aux muqueuses nasales et buccales, relarguer lentement les antibiotiques et avoir une tension superficielle permettant un étalement maximal sur les muqueuses nasales et oropharyngées. La préparation est administrée par vaporisation précise soit sous forme d'aérosol pressurisé distribué par une valve continue ou doseuse soit sous forme de nébulisation distribuée par une pompe précise. Deux poussoirs sont fournis avec chaque flacon : l'un disposant d'une canule longue et fine permettant l'introduction par les narines et la vaporisation des fos¬ ses nasales, l'autre d'une canule permettant une vaporisation large de la cavité oropharyngée.Gram-negative bacillus infections and yeast infections are common in at-risk patients. They cause significant morbidity, they are one of the main causes of the death of these patients, they increase health expenditure by increasing the length of hospital stay. The present invention overcomes this drawback. It includes the combination of three antibiotics administered by spraying into the nasal and oropharyngeal cavities. The three antibiotics associated in the preparation are polymyxin B, tobramycin and amphotericin B. The preparation must adhere to the nasal and oral mucous membranes, slowly release the antibiotics and have a surface tension allowing maximum spreading on the mucous membranes nasal and oropharyngeal. The preparation is administered by precise spraying either in the form of a pressurized aerosol dispensed by a continuous or metering valve or in the form of a nebulization dispensed by a precise pump. Two pushers are supplied with each bottle: one with a long and fine cannula allowing the introduction through the nostrils and the vaporization of the nasal passages, the other with a cannula allowing a broad vaporization of the oropharyngeal cavity .
Les doses distribuées par les valves ou les pompes seront très préci- ses. Elles sont bien entendu fonction de la concentration des antibioti¬ ques au sein de la préparation.The doses dispensed by the valves or pumps will be very precise. They are of course a function of the concentration of antibiotics in the preparation.
La fréquence des applications dépend également de la concentration de ces produits.The frequency of applications also depends on the concentration of these products.
Aucun de ces antibiotiques n'étant absorbé par voie nasale, oropharyn- gée ou digestive, les posologies et donc les concentrations peuvent varier dans une très large part.None of these antibiotics being absorbed by the nasal, oropharyngeal or digestive route, the dosages and therefore the concentrations can vary to a very large extent.
Les caractéristiques et avantages de l'invention ressortent de la des¬ cription qui va suivre à titre d'exemple : pour 30 ml de préparation, on associe - sulfate de polymyxine B : 500 mgThe characteristics and advantages of the invention appear from the description which will follow by way of example: for 30 ml of preparation, there is combined - polymyxin sulfate B: 500 mg
FEϋ.LLE. D£ RZmPLA EmZr-Y sulfate de tobramycine 450 mg amphotéricine B 2500 mg alcool à 90° 1 ml saccharinate de sodium 100 mg essence de menthe 0,02 ml glycérine quantité suffisante pourFEϋ.LLE. D £ RZmPLA EmZr-Y tobramycin sulfate 450 mg amphotericin B 2,500 mg 90 ° alcohol 1 ml sodium saccharin 100 mg mint essence 0.02 ml glycerin sufficient for
30 ml La valve ou la pompe doit être adaptée pour délivrer 0,5 ml à chaque pression. On recommande 6 pressions dans la cavité oropharyngée, 3 pres- sions dans chaque narine à chaque administration et une fréquence de quatre administrations par jour. Dans cet exemple, on administre 400 mg de polymyxine B, 360 mg de tobramycine et 2000 mg d'amphotéricine B par jour.30 ml The valve or pump must be adapted to deliver 0.5 ml each time it is pressed. We recommend 6 pressures in the oropharyngeal cavity, 3 pressures in each nostril with each administration and a frequency of four administrations per day. In this example, 400 mg of polymyxin B, 360 mg of tobramycin and 2000 mg of amphotericin B are administered daily.
Il est recommandé d'associer la vaporisation nasale et oropharyngée à une décontamination sélective du tube digestif par administration orale ou par sonde gastrique avec ces mêmes antibiotiques.It is recommended to combine nasal and oropharyngeal spraying with selective decontamination of the digestive tract by oral administration or by gastric tube with these same antibiotics.
Les indications de ce médicament sont très larges : il doit être em¬ ployé chaque fois qu'un risque d'infection à gram négatif ou de mycose est présent : en réanimation, en hématologie, en chirurgie, en anesthésio- logie, en cancérologie, etc..The indications for this drug are very broad: it must be used whenever a risk of gram negative infection or mycosis is present: in intensive care, hematology, surgery, anesthesiology, oncology, etc.
FEUÎLLE DE REMPLACEMENT REPLACEMENT SHEET

Claims

REVENDICATIONS
1)- Médicament destiné à prévenir les risques d'infections à bacilles gram négatif caractérisé en ce qu'il comporte l'association de trois anti- biotiques : polymyxine B, tobramycine et amphotéricine B administrée par vaporisation dans les cavités nasales et oropharyngées.1) - Medication intended to prevent the risks of infections with gram-negative bacilli, characterized in that it comprises the combination of three antibiotics: polymyxin B, tobramycin and amphotericin B administered by vaporization in the nasal and oropharyngeal cavities.
2) Médicament selon la revendication 1 caractérisé en ce que la pré¬ paration est administrée par vaporisation précise soit sous forme d'aéro¬ sol pressurisé distribué par une valve continue ou doseuse soit sous for- me de nébulisation distribuée par une pompe précise.2) Medicament according to claim 1 characterized in that the preparation is administered by precise spraying either in the form of pressurized aerosol distributed by a continuous or metering valve or in the form of nebulization distributed by a precise pump.
3) Médicament selon la revendication 1 ou la revendication 2 caracté¬ risé en ce que les doses distribuées par les valves ou les pompes sont très précises.3) Medicament according to claim 1 or claim 2 caracté¬ ized in that the doses dispensed by the valves or the pumps are very precise.
4) Médicament selon l'une quelconque des revendications précédentes caractérisé en ce que deux poussoirs sont fournis avec chaque flacon : l'un disposant d'une canule longue et fine permettant l'introduction par les narines, l'autre d'une canule permettant une vaporisation large de la cavité oropharyngée.4) Medicament according to any one of the preceding claims, characterized in that two pushers are supplied with each bottle: one having a long and fine cannula allowing the introduction through the nostrils, the other of a cannula allowing wide vaporization of the oropharyngeal cavity.
FEUILLE DE REMPLACÉ . REPLACED SHEET.
EP19880909559 1987-10-19 1988-10-19 Drug comprising the association of polymyxin b, tobramycin and amphotericin b administered by spraying Ceased EP0338062A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR8714345 1987-10-19
FR8714345A FR2621817B1 (en) 1987-10-19 1987-10-19 DRUG COMPRISING POLYMYXIN B, TOBRAMYCIN AND AMPHOTERICIN B VAPORIZED

Publications (1)

Publication Number Publication Date
EP0338062A1 true EP0338062A1 (en) 1989-10-25

Family

ID=9355910

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19880909559 Ceased EP0338062A1 (en) 1987-10-19 1988-10-19 Drug comprising the association of polymyxin b, tobramycin and amphotericin b administered by spraying

Country Status (4)

Country Link
EP (1) EP0338062A1 (en)
AU (1) AU2614088A (en)
FR (1) FR2621817B1 (en)
WO (1) WO1989003673A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2290708A (en) * 1994-06-28 1996-01-10 Georgi Stankov Pharmaceutical uses of polyene macrolides
GB2290707A (en) * 1994-06-28 1996-01-10 Georgi Stankov Pharmaceutical uses of Amphotericin B
EP2077132A1 (en) 2008-01-02 2009-07-08 Boehringer Ingelheim Pharma GmbH & Co. KG Dispensing device, storage device and method for dispensing a formulation
US10011906B2 (en) 2009-03-31 2018-07-03 Beohringer Ingelheim International Gmbh Method for coating a surface of a component
EP3508239B1 (en) 2009-05-18 2020-12-23 Boehringer Ingelheim International GmbH Adapter, inhalant apparatus and atomizer
EP2504051B1 (en) 2009-11-25 2019-09-04 Boehringer Ingelheim International GmbH Nebulizer
US10016568B2 (en) 2009-11-25 2018-07-10 Boehringer Ingelheim International Gmbh Nebulizer
WO2011064164A1 (en) 2009-11-25 2011-06-03 Boehringer Ingelheim International Gmbh Nebulizer
WO2011160932A1 (en) 2010-06-24 2011-12-29 Boehringer Ingelheim International Gmbh Nebulizer
EP2694220B1 (en) 2011-04-01 2020-05-06 Boehringer Ingelheim International GmbH Medical device comprising a container
US9827384B2 (en) 2011-05-23 2017-11-28 Boehringer Ingelheim International Gmbh Nebulizer
WO2013152894A1 (en) 2012-04-13 2013-10-17 Boehringer Ingelheim International Gmbh Atomiser with coding means
EP2835146B1 (en) 2013-08-09 2020-09-30 Boehringer Ingelheim International GmbH Nebulizer
EP3030298B1 (en) 2013-08-09 2017-10-11 Boehringer Ingelheim International GmbH Nebulizer
US10722666B2 (en) 2014-05-07 2020-07-28 Boehringer Ingelheim International Gmbh Nebulizer with axially movable and lockable container and indicator
EA032459B1 (en) 2014-05-07 2019-05-31 Бёрингер Ингельхайм Интернациональ Гмбх Nebulizer
PL3139979T3 (en) 2014-05-07 2023-12-27 Boehringer Ingelheim International Gmbh Unit, nebulizer and method

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL121455C (en) * 1900-01-01
NL289785A (en) * 1962-11-29
AU539563B2 (en) * 1981-01-21 1984-10-04 Chinoin Gyogyszer Es Vegyeszeti Termekek Gyara Primycin, doxycyline and sisomicin composition

Non-Patent Citations (1)

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Title
See references of WO8903673A1 *

Also Published As

Publication number Publication date
AU2614088A (en) 1989-05-23
WO1989003673A1 (en) 1989-05-05
FR2621817B1 (en) 1990-12-14
FR2621817A1 (en) 1989-04-21

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