Pharmaceutical compositions comprising fentanyl for...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/00 (2006.01) A61K 31/4468 (2006.01) A61P 25/04 (2006.01)

Patent

CA 2511974

This invention provides a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal, which comprises an aqueous solution of (i) fentanyl or a pharmaceutically acceptable salt thereof and (ii) a pharmaceutically acceptable additive selected from (a) a pectin and (b) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (Cmax)that is from 10 to 80% of- that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose.

L'invention concerne une composition destinée à l'administration par voie intranasale de fentanyle ou d'un sel pharmaceutiquement acceptable dudit composé à un animal. Cette composition comprend une solution aqueuse (i) de fentanyle ou d'un sel pharmaceutiquement acceptable dudit composé, et (ii) d'un additif pharmaceutiquement acceptable choisi parmi (a) une pectine et (b) un poloxamère et du chitosane ou un sel ou un dérivé correspondant, à condition que, lorsqu'elle comprend une pectine, cette composition soit sensiblement exempte d'ions métalliques divalents. Ladite composition, en comparaison avec une solution aqueuse simple de fentanyle administrée par voie intranasale à la même dose, permet d'obtenir une concentration plasmatique maximale de fentanyle (C¿max?) comprise entre 10 et 80 % de celle obtenue au moyen d'une solution aqueuse simple de fentanyle administrée par voie intranasale à une dose de fentanyle identique.

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