FR2787713A1 - COMPOSITION AS A MEDICINAL PRODUCT AND USE OF SUCH A COMPOSITION FOR OBTAINING A MEDICINAL PRODUCT FOR ANESTHESIA, ESPECIALLY ANALGESIC MEDICINAL PRODUCT - Google Patents

COMPOSITION AS A MEDICINAL PRODUCT AND USE OF SUCH A COMPOSITION FOR OBTAINING A MEDICINAL PRODUCT FOR ANESTHESIA, ESPECIALLY ANALGESIC MEDICINAL PRODUCT Download PDF

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FR2787713A1
FR2787713A1 FR9816507A FR9816507A FR2787713A1 FR 2787713 A1 FR2787713 A1 FR 2787713A1 FR 9816507 A FR9816507 A FR 9816507A FR 9816507 A FR9816507 A FR 9816507A FR 2787713 A1 FR2787713 A1 FR 2787713A1
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composition
receptors
neuro
action
composition according
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French (fr)
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Johan Huysman
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Priority to FR9816507A priority Critical patent/FR2787713A1/en
Priority to AU21049/00A priority patent/AU2104900A/en
Priority to PCT/EP1999/010512 priority patent/WO2000038678A1/en
Publication of FR2787713A1 publication Critical patent/FR2787713A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/415—1,2-Diazoles
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • 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]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention concerns a composition, as medicine, consisting of at least two different active agents, having at least an activity with respect to neuroreceptors alpha 2; an activity with respect to NMDA neuroreceptors; an activity with respect to morphinic neuroreceptors. The invention also concerns the use of said composition to obtain a medicine for anaesthesia, in particular an analgesic medicine.

Description

L'invention concerne une composition en tant que médicament etThe invention relates to a composition as a medicament and

l'utilisation d'une telle composition pour l'obtention d'un  the use of such a composition for obtaining a

médicament destiné à l'anesthésie, notamment un médicament analgésique.  medication for anesthesia, including an analgesic medication.

Toutefois, bien que plus particulièrement prévue pour de telles applications, elle pourra être utilisée pour d'autres applications thérapeutiques. Actuellement, pour anesthésier un patient, on utilise différentes actions, à savoir une action hypnotique pour l'endormir, une action analgésique pour limiter les stimulations douloureuses, une paralysation des  However, although more particularly intended for such applications, it may be used for other therapeutic applications. Currently, to anesthetize a patient, different actions are used, namely a hypnotic action to put him to sleep, an analgesic action to limit painful stimulation, paralysis of the

muscles et/ou une neutralisation des réflexes autonomes.  muscles and / or neutralization of autonomous reflexes.

De telles actions sont obtenues par l'administration de médicaments, par exemple en phase opératoire, juste avant le début de l'acte chirurgical.  Such actions are obtained by the administration of drugs, for example in the operating phase, just before the start of the surgical act.

Cette administration peut être accompagnée, en phase pré-  This administration can be accompanied, in the pre-

opératoire, dans les heures précédant l'opération, de l'administration de  operation, in the hours preceding the operation, of the administration of

sédatifs destinés notamment à limiter l'anxiété du patient.  sedatives intended in particular to limit the patient's anxiety.

Pour ce qui est de l'analgésie, on connaît de nombreux  As for analgesia, we know many

agents actifs tels que, par exemple, des composés synthétiques morphino-  active agents such as, for example, synthetic morphino-

mimétiques, permettant d'obtenir l'action souhaitée sur le système nerveux.  mimetics, allowing to obtain the desired action on the nervous system.

Toutefois, ces agents présentent actuellement un " effet de queue " qui se traduit chez le patient par l'apparition de symptômes tels que  However, these agents presently present a "tail effect" which results in the patient in the appearance of symptoms such as

dépressions respiratoires, nausées, vomissements, vertiges et/ou autres.  respiratory depression, nausea, vomiting, dizziness and / or others.

Ils obligent ainsi à une surveillance particulièrement attentive du patient à la fois lors de l'intervention chirurgicale et après celle-ci, notamment pendant la phase de réveil, en cas d'anesthésie avec endormissement. Le but de la présente invention est de proposer un médicament qui pallie les inconvénients précités grâce à l'emploi d'agents actifs dont le ou les effets principaux soient préservés tout en limitant voire en éliminant les effets secondaires indésirables de chacun d'eux, notamment un médicament anesthésique ou plus précisément analgésique sans " effet de  They therefore require particularly careful monitoring of the patient both during and after the surgical intervention, especially during the recovery phase, in the event of anesthesia with falling asleep. The aim of the present invention is to propose a medicament which overcomes the aforementioned drawbacks thanks to the use of active agents the main effect or effects of which are preserved while limiting or even eliminating the undesirable side effects of each of them, in particular an anesthetic or more precisely analgesic drug without "

queue ".tail ".

Un autre but de la présente invention est de proposer un médicament, notamment anesthétisique ou plus précisément analgésique, qui  Another object of the present invention is to propose a medicament, in particular an anesthetic or more precisely analgesic, which

puisse être administré en phase pré-opératoire.  can be administered in the preoperative phase.

Un autre but de la présente invention est de proposer un médicament qui puisse présenter à la fois une action analgésique et une  Another object of the present invention is to provide a medicament which can exhibit both an analgesic action and a

action sédative.sedative action.

Un avantage du médicament conforme à l'invention est de permettre, grâce à l'élimination des effets de queue, de limiter le temps de prise en charge totale des patients au sein des structures spécialisées, notamment hospitalières, prévues à cet effet et de permettre ainsi le  An advantage of the medicament in accordance with the invention is that it makes it possible, thanks to the elimination of the tail effects, to limit the time of total care of the patients within the specialized structures, in particular hospitals, provided for this purpose and to allow so the

développement de la chirurgie, dite ambulatoire.  development of so-called outpatient surgery.

D'autres buts et avantages de l'invention apparaîtront au  Other objects and advantages of the invention will become apparent from

cours de la description qui va suivre qui n'est donnée qu'à titre indicatif et qui  during the description which follows which is given for information only and which

n'a pas pour but de la limiter.is not intended to limit it.

L'invention concerne tout d'abord une composition, constituée d'au moins deux agents actifs différents, présentant au moins: - une action vis-àvis des neuro-récepteurs x2, - une action vis-à-vis des neuro-récepteurs NMDA, - une action vis-à-vis des neuro-récepteurs morphiniques,  The invention relates first of all to a composition, consisting of at least two different active agents, having at least: - an action with respect to x2 neuro-receptors, - an action with regard to NMDA neuro-receptors , - an action towards morphine neuro-receptors,

en tant que médicaments.as drugs.

L'invention concerne également une utilisation de la composition décrite ci-dessus pour l'obtention d'un médicament destiné à  The invention also relates to a use of the composition described above for obtaining a medicament intended for

l'anesthésie, notamment un médicament analgésique.  anesthesia, including an analgesic medication.

L'invention sera mieux comprise à la lecture de la description  The invention will be better understood on reading the description

suivante qui développe certains de ces modes de réalisation.  following which develops some of these embodiments.

L'invention concerne tout d'abord une composition, considérée en tant que médicament, constituée d'au moins deux agents actifs différents, présentant au moins: - une action vis-à-vis des neuro- récepteurs cX2, une action vis-à-vis des neuro-récepteurs NMDA, - une action vis-à-vis des neuro-récepteurs morphiniques,  The invention relates first of all to a composition, considered as a medicament, consisting of at least two different active agents, having at least: - an action with respect to the cX2 neuro receptors, an action with -vis NMDA neuro-receptors, - an action vis-à-vis morphine neuro-receptors,

notamment les récepteurs 1i.including 1i receptors.

Sans que ceci prétende être une explication complète et fidèle des mécanismes biologiques mis en jeu, il semble que la combinaison des actions évoquées plus haut permette simultanément la libération de la noradrénaline secondaire à la stimulation nerveuse dans le cortex et le bulbe  Without claiming to be a complete and faithful explanation of the biological mechanisms involved, it seems that the combination of the actions mentioned above simultaneously allows the release of norepinephrine secondary to nerve stimulation in the cortex and the bulb

ainsi que l'inhibition de la récaptation de la noradrénaline et de la sérotonine.  as well as the inhibition of norepinephrine and serotonin rehabilitation.

Parallèlement, une intervention à plusieurs niveaux du système nerveux, notamment au niveau de la moelle, pour ce qui est de l'ensemble de ces  At the same time, intervention at several levels of the nervous system, in particular at the level of the marrow, with regard to all of

neuro-récepteurs paraît possible.neuro-receptors seems possible.

On obtient ainsi une potentialisation des effets de chacun des agents actifs employés, notamment une diminution, voire une disparition plus  We thus obtain a potentiation of the effects of each of the active agents employed, in particular a reduction, even a disappearance

rapide des effets secondaires indésirables de ceux-ci.  rapid unwanted side effects from these.

Grâce à ces résultats, il n'est alors plus nécessaire de surveiller les patients pendant de longues périodes après l'administration d'un tel médicament, notamment après un acte chirurgical pendant lequel il a servi d'analgésique. Selon un mode de réalisation avantageux, la composition conforme à l'invention comprend:  Thanks to these results, it is no longer necessary to monitor patients for long periods after the administration of such a drug, especially after a surgical procedure during which it served as an analgesic. According to an advantageous embodiment, the composition according to the invention comprises:

- un premier agent actif présentant une action agoniste vis-à-  - a first active agent exhibiting an agonist action towards

vis des neuro-récepteurs Uc2,against Uc2 neuro-receptors,

- un second agent actif présentant une action antagoniste vis-  - a second active agent having an antagonistic action vis-

à-vis des neuro-récepteurs NMDA,towards NMDA neuro receptors,

- un troisième agent actif présentant une action agoniste vis-  - a third active agent exhibiting an agonist action vis-

à-vis des neuro-récepteurs morphiniques.  against morphine neuro-receptors.

Bien qu'une telle composition puisse présenter en elle-même un effet sédatif, elle pourra en outre comprendre, éventuellement, un quatrième agent actif présentant un effet anxiolitique, par exemple par action  Although such a composition may in itself have a sedative effect, it may also optionally include a fourth active agent having an anxiolitic effect, for example by action

sur les neuro-récepteurs GABA.on GABA neuro receptors.

Ledit premier agent est choisi, notamment, parmi la clonidine,  Said first agent is chosen, in particular, from clonidine,

la dexmédetomidine, I'azépexole et/ou d'autres composés équivalents visà-  dexmedetomidine, azepexole and / or other equivalent compounds

vis de leur action sur les neuro-récepteurs cL2.  vis their action on cL2 neuro receptors.

Ledit second agent est, par exemple, la kétamine. Il pourra aussi bien s'agir d'un des deux énantiomères de cette molécule que d'un  Said second agent is, for example, ketamine. It could as well be one of the two enantiomers of this molecule as a

mélange racémiques de ceux-ci.racemic mixture of these.

Ledit troisième agent est, par exemple, un produit morphino-  Said third agent is, for example, a morphino-

mimétique, notamment synthétique, éventuellement du tramadol.  mimetic, in particular synthetic, possibly tramadol.

Ledit quatrième agent est, par exemple, de la famille de la  The said fourth officer is, for example, from the family of the

benzodiazepine. Il s'agit, notamment, de midazolam.  benzodiazepine. These include midazolam.

A titre d'exemple, la composition conforme à l'invention, comprend ainsi, en combinaison de la clonidine, de la kétamine, du tramadol  By way of example, the composition according to the invention thus comprises, in combination with clonidine, ketamine, tramadol

et, éventuellement du midazolam.and possibly midazolam.

Pour la clonidine, il s'agit plus précisément, notamment, de chlorhydrate de clonidine, pour la kétamine, notamment, de chIrorure de kétamine et pour le tramadol, de chlorhydrate de tramadol ou un autre de  For clonidine, it is more specifically, in particular, clonidine hydrochloride, for ketamine, in particular, ketamine chloride and for tramadol, tramadol hydrochloride or another of

leurs sels.their salts.

Cela étant, ladite composition se présente, par exemple, sous forme liquide, notamment aqueux, et comprend: - 5 à 50 microgrammes par millilitre de clonidine, - i à 10 milligrammes par millilitre de kétamine,  However, said composition is, for example, in liquid form, in particular aqueous form, and comprises: - 5 to 50 micrograms per milliliter of clonidine, - i to 10 milligrams per milliliter of ketamine,

- 5 à 50 milligrammes par millilitre de tramadol.  - 5 to 50 milligrams per milliliter of tramadol.

A titre d'exemple particulier, on peut prévoir une composition contenant environ 35 microgrammes par millilitre de clonidine, environ 2,5 milligrammes par millilitre de kétamine et environ 25 milligrammes par millilitre  As a specific example, one can provide a composition containing about 35 micrograms per milliliter of clonidine, about 2.5 milligrams per milliliter of ketamine and about 25 milligrams per milliliter

de tramadol.of tramadol.

La posologie du médicament pourra être déterminée, notamment, en divisant le poids du patient par 20 pour obtenir le nombre de  The dosage of the drug can be determined, in particular, by dividing the patient's weight by 20 to obtain the number of

millilitres de composition conforme à l'invention nécessaire.  milliliters of composition in accordance with the invention necessary.

L'invention concerne également l'utilisation de la composition décrite plus haut pour l'obtention d'un médicament destiné à l'anesthésie,  The invention also relates to the use of the composition described above for obtaining a medicament intended for anesthesia,

notamment un médicament analgésique.  including an analgesic medication.

La composition décrite plus haut pourra également, entre  The composition described above may also, between

autres, être utilisée pour l'obtention d'un médicament anti-stress.  others, be used to obtain an anti-stress medication.

Ledit médicament est destiné à être administré, notamment,  Said medicament is intended to be administered, in particular,

par voie sublinguale, orale et/ou péridurale.  sublingually, orally and / or epidurally.

Il peut être donné, par exemple, de manière pré-opératoire, tout en conservant l'ensemble de ses effets et de ses avantages. D'autres modes de réalisation, à la portée de l'homme de l'art, auraient naturellement pu être envisagés sans pour autant sortir du cadre de l'invention.  It can be given, for example, preoperatively, while retaining all of its effects and advantages. Other embodiments, within the reach of those skilled in the art, could naturally have been envisaged without departing from the scope of the invention.

Claims (10)

REVENDICATIONS 1. Composition constituée d'au moins deux agents actifs différents, présentant au moins: - une action vis-à-vis des neuro-récepteurs a2, - une action vis-à-vis des neuro-récepteurs NMDA, - une action vis-à-vis des neuro-récepteurs morphiniques,  1. Composition consisting of at least two different active agents, having at least: - an action with respect to the neuro-receptors a2, - an action with respect to the neuro-receptors NMDA, - an action with - with morphine neuro-receptors, en tant que médicaments.as drugs. 2. Composition selon la revendication 1 comprenant:  2. Composition according to claim 1 comprising: - un premier agent actif présentant une action agoniste vis-à-  - a first active agent exhibiting an agonist action towards vis des neuro-récepteurs aO2,vis aO2 neuro receptors, - un second agent actif présentant une action antagoniste vis-  - a second active agent having an antagonistic action vis- à-vis des neuro-récepteurs NMDA,towards NMDA neuro receptors, - un troisième agent actif présentant une action agoniste vis-  - a third active agent exhibiting an agonist action vis- à-vis des neuro-récepteurs morphiniques.  against morphine neuro-receptors. 3. Composition selon la revendication 2 comprenant en outre un quatrième agent actif présentant un effet anxiolitique par action sur les  3. Composition according to claim 2 further comprising a fourth active agent having an anxiolitic effect by action on the neuro-récepteurs GABA.GABA neuro receptors. 4. Composition selon la revendication 2, dans lequel ledit premier agent est choisi parmi la clonidine, la dexmédétomidine et/ou  4. Composition according to claim 2, in which said first agent is chosen from clonidine, dexmedetomidine and / or I'azépéxole.Azepexxole. 5. Composition selon la revendication 2, dans lequel ledit  5. The composition of claim 2, wherein said second agent est la kétamine.second agent is ketamine. 6. Composition selon la revendication 2, dans lequel ledit  6. The composition of claim 2, wherein said troisième agent est un produit morphinomimétique synthétique.  third agent is a synthetic morphine product. 7. Composition selon la revendication 1 comprenant en combinaison: - de la clonidine, - de la kétamine, - du tramadol,  7. Composition according to claim 1 comprising in combination: - clonidine, - ketamine, - tramadol, - et éventuellement du midazolam.- and possibly midazolam. 8. Composition selon la revendication 7 se présentant sous forme liquide et comprenant: - 5 à 50 microgrammes par millilitre de clonidine, - 1 à 10 milligrammes par millilitre de kétamine,  8. Composition according to Claim 7, presented in liquid form and comprising: - 5 to 50 micrograms per milliliter of clonidine, - 1 to 10 milligrams per milliliter of ketamine, - 5 à 50 milligrammes par millilitre de tramadol.  - 5 to 50 milligrams per milliliter of tramadol. 9. Utilisation de la composition selon la revendication 1 pour l'obtention d'un médicament destiné à l'anesthésie, notamment un  9. Use of the composition according to claim 1 for obtaining a medicament intended for anesthesia, in particular a médicament analgésique.analgesic medication. 10. Utilisation selon la revendication 9, dans lequel ledit médicament est destiné à être administré par voie sublinguale, orale et/ou  10. Use according to claim 9, wherein said medicament is intended to be administered by sublingual, oral and / or péridurale et/ou de manière pré-opératoire.  epidural and / or preoperatively.
FR9816507A 1998-12-23 1998-12-23 COMPOSITION AS A MEDICINAL PRODUCT AND USE OF SUCH A COMPOSITION FOR OBTAINING A MEDICINAL PRODUCT FOR ANESTHESIA, ESPECIALLY ANALGESIC MEDICINAL PRODUCT Withdrawn FR2787713A1 (en)

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FR9816507A FR2787713A1 (en) 1998-12-23 1998-12-23 COMPOSITION AS A MEDICINAL PRODUCT AND USE OF SUCH A COMPOSITION FOR OBTAINING A MEDICINAL PRODUCT FOR ANESTHESIA, ESPECIALLY ANALGESIC MEDICINAL PRODUCT
AU21049/00A AU2104900A (en) 1998-12-23 1999-12-23 Composition used as medicine and use of same for obtaining medicine for anaesthesia, in particular analgesic medicine
PCT/EP1999/010512 WO2000038678A1 (en) 1998-12-23 1999-12-23 Composition used as medicine and use of same for obtaining a medicine for anaesthesia, in particular analgesic medicine

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FR9816507A FR2787713A1 (en) 1998-12-23 1998-12-23 COMPOSITION AS A MEDICINAL PRODUCT AND USE OF SUCH A COMPOSITION FOR OBTAINING A MEDICINAL PRODUCT FOR ANESTHESIA, ESPECIALLY ANALGESIC MEDICINAL PRODUCT

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