Intranasal formulations of interferon beta free of...

A - Human Necessities – 61 – K

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A61K 38/21 (2006.01) A61K 47/00 (2006.01) A61P 31/12 (2006.01) A61P 37/00 (2006.01)

Patent

CA 2569137

Compositions and methods are provided for intranasal delivery of interferon- .szlig. yielding improved pharmacokinetic and pharmacodynamic results wherein the composition is free of a stabilizer that is a protein or a polypeptide. In certain aspects of the invention, the interferon-.szlig. is delivered to the intranasal mucosa along with one or more intranasal delivery-enhancing agent(s) to yield substantially increased absorption and/or bioavailability of the interferon-.szlig. and/or a substantially decreased time to maximal concentration of interferon-.szlig. in a tissue of a subject as compared to controls where the interferon-.szlig. is administered to the same intranasal site alone or formulated according to previously disclosed reports. The enhancement of intranasal delivery of interferon-.szlig. according to the methods and compositions of the present invention allows for the effective pharmaceutical use of these agents to treat a variety of diseases and conditions in mammalian subjects.

L'invention concerne des compositions et des procédés d'administration intranasale d' interféron-.szlig. ayant des résultats pharmacodynamiques et pharmacocinétiques améliorés dans lequel la composition ne comporte pas de stabilisant protéine ou polypeptide. Dans certains aspects de l'invention, l'interféron-.szlig. est administré à la muqueuse intranasale avec un ou plusieurs agents d'augmentation d'administration intranasale permettant d'augmenter sensiblement l'absorption et/ou la biocapacité de l'interféron-.szlig. et ou de diminuer sensiblement le temps nécessair pour atteindre la concentration maximale de l'interféron-.szlig. dans un tissu du sujet comparé à des témoins pour contrôler si l'interféron-.szlig. est administré au même site intranasal seul ou formulé selon les rapports précédemment divulgués, L'amélioration de l'administration intranasale d'interféron-.szlig. selon les procédés et compositions de la présente invention permet un usage pharmaceutique efficace de ces agents pour traiter une variété de maladies et d'états chez des sujets mammifères.

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