WO2000038678A1 - Composition used as medicine and use of same for obtaining a medicine for anaesthesia, in particular analgesic medicine - Google Patents

Composition used as medicine and use of same for obtaining a medicine for anaesthesia, in particular analgesic medicine Download PDF

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Publication number
WO2000038678A1
WO2000038678A1 PCT/EP1999/010512 EP9910512W WO0038678A1 WO 2000038678 A1 WO2000038678 A1 WO 2000038678A1 EP 9910512 W EP9910512 W EP 9910512W WO 0038678 A1 WO0038678 A1 WO 0038678A1
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Prior art keywords
receptors
neuro
action
medicine
composition
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PCT/EP1999/010512
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French (fr)
Inventor
Johan Huysman
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Johan Huysman
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Priority to AU21049/00A priority Critical patent/AU2104900A/en
Publication of WO2000038678A1 publication Critical patent/WO2000038678A1/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]

Definitions

  • TITLE Composition as a medicament and use of such a composition for obtaining a medicament intended for anesthesia, in particular analgesic medicament.
  • the invention relates to a composition as a medicament and to the use of such a composition for obtaining a medicament intended for anesthesia, in particular an analgesic medicament.
  • Such actions are obtained by the administration of drugs, for example in the operating phase, just before the start of the surgical act.
  • This administration may be accompanied, in the preoperative phase, in the hours preceding the operation, by the administration of sedatives intended in particular to limit the patient's anxiety.
  • analgesia numerous active agents are known, such as, for example, synthetic morphomimetic compounds, making it possible to obtain the desired action on the nervous system.
  • 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 "tail effect".
  • Another object of the present invention is to propose a medicament, in particular anesthetic or more precisely analgesic, which can be administered in the pre-operative phase.
  • Another object of the present invention is to provide a medicament which can exhibit both an analgesic action and a sedative action.
  • 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 thus the development of so-called ambulatory surgery.
  • Other objects and advantages of the invention will appear during the description which follows which is given for information only and which is not intended to limit it.
  • 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 the neuro-receptors ⁇ 2 ,
  • the invention also relates to a use of the composition described above for obtaining a medicament intended for anesthesia, in particular an analgesic medicament.
  • 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 vis-à-vis the neuro-receptors ⁇ 2 ,
  • the composition in accordance with the invention comprises: a first active agent having an agonist action with respect to the ⁇ 2 neuro-receptors,
  • a third active agent having an agonist action with respect to morphine neuro-receptors, particularly tramadol because of its double analgesic action, one in the direction of the ⁇ receptors and the other in the direction of the norepinephrine receptors and serotonin.
  • Said second agent is, for example, ketamine. It could as well be one of the two enantiomers of this molecule as a racemic mixture of these.
  • Said third agent is, as mentioned above, for example, a morphino-mimetic product, in particular synthetic, such as tramadol or equivalent.
  • Said fourth agent is, for example, from the benzodiazepine family. These include midazolam.
  • composition in accordance with the invention thus comprises, in combination with clonidine, ketamine, tramadol and, optionally midazolam.
  • clonidine it is more specifically, in particular, clonidine hydrochloride, for ketamine, in particular, ketamine chiroride and for tramadol, tramadol hydrochloride or another of their salts.
  • said composition is, for example, in liquid form, in particular aqueous form, and comprises: 5 to 50 micrograms per milliliter of clonidine,
  • ketamine - 1 to 10 milligrams per milliliter of ketamine, - 5 to 50 milligrams per milliliter of tramadol.
  • the dosage of the medicament may be determined, in particular, by dividing the weight of the patient by 20 to obtain the number of milliliters of composition in accordance with the invention necessary.
  • the invention also relates to the use of the composition described above for obtaining a medicament intended for anesthesia, in particular an analgesic medicament.
  • composition described above may also, inter alia, be used for obtaining an anti-stress medication.
  • Said medicament is intended to be administered, in particular, by sublingual, oral and / or epidural route.

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

TITRE : Composition en tant que médicament et utilisation d'une telle composition pour l'obtention d'un médicament destiné à l'anesthésie, notamment médicament analgésique.TITLE: Composition as a medicament and use of such a composition for obtaining a medicament intended for anesthesia, in particular analgesic medicament.
L'invention concerne une composition en tant que médicament et l'utilisation d'une telle composition pour l'obtention d'un médicament destiné à l'anesthésie, notamment un médicament analgésique.The invention relates to a composition as a medicament and to the use of such a composition for obtaining a medicament intended for anesthesia, in particular an analgesic medicament.
Toutefois, bien que plus particulièrement prévue pour de telles applications, elle pourra être utilisée pour d'autres applications thérapeutiques.However, although more particularly intended for such applications, it may be used for other therapeutic applications.
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 muscles et/ou une neutralisation des réflexes autonomes.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 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 préopératoire, dans les heures précédant l'opération, de l'administration de sédatifs destinés notamment à limiter l'anxiété du patient.This administration may be accompanied, in the preoperative phase, in the hours preceding the operation, by the administration of sedatives intended in particular to limit the patient's anxiety.
Pour ce qui est de l'analgésie, on connaît de nombreux agents actifs tels que, par exemple, des composés synthétiques morphino- mimétiques, permettant d'obtenir l'action souhaitée sur le système nerveux.With regard to analgesia, numerous active agents are known, such as, for example, synthetic morphomimetic compounds, making it possible 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 dépressions respiratoires, nausées, vomissements, vertiges et/ou autres. 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.However, these agents presently present a "tail effect" which is manifested in the patient by the appearance of symptoms such as respiratory depression, nausea, vomiting, dizziness and / or others. 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.
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 queue ».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 "tail effect".
Un autre but de la présente invention est de proposer un médicament, notamment anesthetisique ou plus précisément analgésique, qui puisse être administré en phase pré-opératoire.Another object of the present invention is to propose a medicament, in particular anesthetic or more precisely analgesic, which can be administered in the pre-operative phase.
Un autre but de la présente invention est de proposer un médicament qui puisse présenter à la fois une action analgésique et une action sédative. 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 développement de la chirurgie, dite ambulatoire. D'autres buts et avantages de l'invention apparaîtront au cours de la description qui va suivre qui n'est donnée qu'à titre indicatif et qui n'a pas pour but de la limiter.Another object of the present invention is to provide a medicament which can exhibit both an analgesic action and a sedative action. 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 thus the development of so-called ambulatory surgery. Other objects and advantages of the invention will appear during the description which follows which is given for information only and which 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-à-vis des neuro-récepteurs α2 ,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 the neuro-receptors α 2 ,
- une action vis-à-vis des neuro-récepteurs NMDA,- an action vis-à-vis the NMDA neuro-receptors,
- une action vis-à-vis des neuro-récepteurs morphiniques, en tant que médicaments.- an action vis-à-vis the morphine neuro-receptors, as drugs.
L'invention concerne également une utilisation de la composition décrite ci-dessus pour l'obtention d'un médicament destiné à l'anesthésie, notamment un médicament analgésique.The invention also relates to a use of the composition described above for obtaining a medicament intended for anesthesia, in particular an analgesic medicament.
L'invention sera mieux comprise à la lecture de la description suivante qui développe certains de ces modes de réalisation.The invention will be better understood on reading the following description 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 α2,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 vis-à-vis the neuro-receptors α 2 ,
- une action vis-à-vis des neuro-récepteurs NMDA,- an action vis-à-vis the NMDA neuro-receptors,
- une action vis-à-vis des neuro-récepteurs morphiniques, notamment les récepteurs μ, ainsi qu'éventuellement une action vis-à-vis des récepteurs de la sérotonine et de la noradrénaline.- an action vis-à-vis the morphine neuro-receptors, in particular the μ receptors, as well as possibly an action vis-à-vis the serotonin and norepinephrine receptors.
On obtient ainsi une potentialisation des effets de chacun des agents actifs employés, notamment une diminution, voire une disparition plus rapide des effets secondaires indésirables de ceux-ci.We thus obtain a potentiation of the effects of each of the active agents employed, in particular a reduction, or even a more rapid disappearance of the undesirable side effects of 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.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.
Selon un mode de réalisation avantageux, la composition conforme à l'invention comprend : - un premier agent actif présentant une action agoniste vis-à- vis des neuro-récepteurs α2,According to an advantageous embodiment, the composition in accordance with the invention comprises: a first active agent having an agonist action with respect to the α 2 neuro-receptors,
- un second agent actif présentant une action antagoniste vis- à-vis des neuro-récepteurs NMDA,a second active agent exhibiting an antagonistic action with respect to the NMDA neuro-receptors,
- un troisième agent actif présentant une action agoniste vis-à- vis des neuro-récepteurs morphiniques, particulièrement du tramadol en raison de sa double action analgésique, l'une en direction des récepteurs μ et l'autre en direction des récepteurs de la noradrénaline et de la sérotonine.- a third active agent having an agonist action with respect to morphine neuro-receptors, particularly tramadol because of its double analgesic action, one in the direction of the μ receptors and the other in the direction of the norepinephrine receptors and serotonin.
Sans que ceci prétende être une explication complète et fidèle des mécanismes biologiques mis en jeu, il semble que la combinaison des agents évoqués plus haut permette simultanément la libération de la noradrénaline secondaire à la stimulation nerveuse dans le cortex et le bulbe ainsi que l'inhibition de la récaptation de la noradrénaline et de la sérotonine. Parallèlement, une intervention à plusieurs niveaux du système nerveux, notamment au niveau de la moelle, pour ce qui est de l'ensemble de ces neuro-récepteurs paraît possible. On a alors une synergie et une potentialisation des effets des agents employés. 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 sur les neuro-récepteurs GABA. Ledit premier agent est choisi, notamment, parmi la clonidine, la dexmédetomidine, Pazépexole et/ou d'autres composés équivalents vis-à-vis de leur action sur les neuro-récepteurs α2.Without claiming to be a complete and faithful explanation of the biological mechanisms involved, it seems that the combination of the agents mentioned above simultaneously allows the release of norepinephrine secondary to nerve stimulation in the cortex and the bulb as well as the inhibition noradrenaline and serotonin rehabilitation. At the same time, intervention at several levels of the nervous system, particularly in the spinal cord, with regard to all of these neuro-receptors seems possible. We then have a synergy and a potentiation of the effects of the agents used. 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 on the GABA neuro-receptors. Said first agent is chosen, in particular, from clonidine, dexmedetomidine, Pazepexole and / or other compounds which are equivalent with regard to their action on the neuro receptors α 2 .
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 mélange racémiques de ceux-ci.Said second agent is, for example, ketamine. It could as well be one of the two enantiomers of this molecule as a racemic mixture of these.
Ledit troisième agent est comme évoque plus haut, par exemple, un produit morphino-mimétique, notamment synthétique, tel que le tramadol ou équivalent.Said third agent is, as mentioned above, for example, a morphino-mimetic product, in particular synthetic, such as tramadol or equivalent.
Ledit quatrième agent est, par exemple, de la famille de la benzodiazepine. Il s'agit, notamment, de midazolam.Said fourth agent is, for example, from the benzodiazepine family. 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 et, éventuellement du midazolam.By way of example, the composition in accordance with the invention thus comprises, in combination with clonidine, ketamine, tramadol and, optionally 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 leurs sels.For clonidine, it is more specifically, in particular, clonidine hydrochloride, for ketamine, in particular, ketamine chiroride and for tramadol, tramadol hydrochloride or another of 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,That said, said composition is, for example, in liquid form, in particular aqueous form, and comprises: 5 to 50 micrograms per milliliter of clonidine,
- 1 à 10 milligrammes par millilitre de kétamine, - 5 à 50 milligrammes par millilitre de 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 de tramadol. La posologie du médicament pourra être déterminée, notamment, en divisant le poids du patient par 20 pour obtenir le nombre de millilitres de composition conforme à l'invention nécessaire.- 1 to 10 milligrams per milliliter of ketamine, - 5 to 50 milligrams per milliliter of tramadol. 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 of tramadol. The dosage of the medicament may be determined, in particular, by dividing the weight of the patient by 20 to obtain the number of 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, notamment un médicament analgésique.The invention also relates to the use of the composition described above for obtaining a medicament intended for anesthesia, in particular an analgesic medicament.
La composition décrite plus haut pourra également, entre autres, être utilisée pour l'obtention d'un médicament anti-stress.The composition described above may also, inter alia, be used for obtaining an anti-stress medication.
Ledit médicament est destiné à être administré, notamment, par voie sublinguale, orale et/ou péridurale.Said medicament is intended to be administered, in particular, by sublingual, oral and / or epidural route.
Il peut être donné, par exemple, de manière pré-opératoire, tout en conservant l'ensemble de ses effets et de ses avantages.It can be given, for example, preoperatively, while retaining all of its effects and advantages.
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. 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

REVENDICATIONS
1. Composition constituée d'au moins deux agents actifs différents, présentant au moins :1. Composition consisting of at least two different active agents, having at least:
- une action vis-à-vis des neuro-récepteurs α2, - une action vis-à-vis des neuro-récepteurs NMDA,- an action with respect to the neuro-receptors α 2 , - an action with respect to the neuro-receptors NMDA,
- une action vis-à-vis des neuro-récepteurs morphiniques, en tant que médicaments.- an action vis-à-vis the morphine neuro-receptors, 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- vis des neuro-récepteurs α2,a first active agent having an agonist action with respect to the α 2 neuro-receptors,
- un second agent actif présentant une action antagoniste vis- à-vis des neuro-récepteurs NMDA,a second active agent exhibiting an antagonistic action with respect to the NMDA neuro-receptors,
- un troisième agent actif présentant une action agoniste vis-à- vis des neuro-récepteurs morphiniques. - a third active agent exhibiting an agonist action with respect to morphine neuro-receptors.
3. Composition selon la revendication 2 comprenant en outre un quatrième agent actif présentant un effet anxiolitique par action sur les neuro-récepteurs GABA.3. Composition according to claim 2 further comprising a fourth active agent having an anxiolitic effect by action on the GABA neuro-receptors.
4. Composition selon la revendication 2, dans lequel ledit premier agent est choisi parmi la clonidine, la dexmedetomidine et/ou l'azépéxole.4. Composition according to claim 2, in which said first agent is chosen from clonidine, dexmedetomidine and / or azeepexxole.
5. Composition selon la revendication 2, dans lequel ledit second agent est la kétamine.5. The composition of claim 2, wherein said second agent is ketamine.
6. Composition selon la revendication 2, dans lequel ledit troisième agent est un produit morphinomimétique synthétique. 6. The composition of claim 2, wherein said third agent is a synthetic morphine product.
7. Composition selon la revendication 1 comprenant en combinaison :7. Composition according to claim 1 comprising in combination:
- de la clonidine,- clonidine,
- de la kétamine,- ketamine,
- du tramadol, - et éventuellement du midazolam.- tramadol, - and possibly midazolam.
8. Composition selon la revendication 7 se présentant sous forme liquide et comprenant :8. A composition according to claim 7 in the form of liquid form and comprising:
- 5 à 50 microgrammes par millilitre de clonidine, - 1 à 10 milligrammes par millilitre de kétamine,- 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 médicament analgésique.9. Use of the composition according to claim 1 for obtaining a medicament intended for anesthesia, in particular an analgesic medicament.
10. Utilisation selon la revendication 9, dans lequel ledit médicament est destiné à être administré par voie sublinguale, orale et/ou péridurale et/ou de manière pré-opératoire. 10. Use according to claim 9, wherein said medicament is intended to be administered by sublingual, oral and / or epidural route and / or in a preoperative manner.
PCT/EP1999/010512 1998-12-23 1999-12-23 Composition used as medicine and use of same for obtaining a medicine for anaesthesia, in particular analgesic medicine WO2000038678A1 (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
FR98/16507 1998-12-23

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