Galenic form for the administration of an active ingredient

Galenic form for the oral transmucosal administration of an active ingredient for accelerated induction of sleep and/or the treatment of sleep disorders and/or the treatment of a central nervous system attack, wherein said active ingredient is lipophilic or amphiphilic and is in a state of stable an...

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Bibliographische Detailangaben
Hauptverfasser: PEROVITCH PHILIPPE, AUZERIE JACK
Format: Patent
Sprache:eng
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Zusammenfassung:Galenic form for the oral transmucosal administration of an active ingredient for accelerated induction of sleep and/or the treatment of sleep disorders and/or the treatment of a central nervous system attack, wherein said active ingredient is lipophilic or amphiphilic and is in a state of stable and complete dissolution in an aqueous-alcoholic solution comprising between 35% and 70% by weight of ethanol and between 30% and 65% by weight of water, generating, in this aqueous-alcoholic solution, the formation of nanostructures of said active ingredient under consideration, facilitating the crossing of the blood-brain barrier by said active ingredient, wherein said active ingredient is in base and/or salt form and belongs to the chemical families of sleep inducers or modulators of lipophilic or amphiphilic nature and having a molecular weight of less than 1000 daltons, wherein said active ingredient is chosen from the imidazopyridine family, comprising zolpidem, the cyclopyrrolone family, comprising eszopiclone, the pyrazolopyrimidine family, comprising zaleplon, the benzodiazepine family, comprising midazolam and brotizolam, the H1 antihistamine sedative family, comprising doxylamine and cyproheptadine, and/or the melatonin and melatonin agonist family, comprising melatonin, ramelteon and agomelatine, wherein the volume of said aqueous-alcoholic solution is less than or equal to 2 ml and said active ingredient is present at a dose of less than or equal to 8 mg, all of said active ingredient being absorbed transmucosally through the mucosae of the floor of the oral cavity, in particular the gingivo-jugal, para-gingival, jugal or sublingual mucosae.