Compositions and methods for enhanced mucosal delivery of...

A - Human Necessities – 61 – K

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A61K 9/08 (2006.01) A61K 38/27 (2006.01)

Patent

CA 2528465

Pharmaceutical formulations are described comprising at least one growth hormone and one or more intranasal delivery-enhancing agents for enhanced nasal mucosal delivery of the growth hormone. In one aspect, the intranasal delivery formulations and methods provide enhanced delivery of growth hormone to the blood plasma, for example, by yielding a peak concentration (Cmax) of the growth hormone in an hepatic portal vein or a blood plasma of the subject that is 20% or greater compared to a peak concentration of the growth hormone in the hepatic portal vein or the blood plasma of the subject following administration to the subject of a same concentration or dose of the growth hormone to the subject by subcutaneous injection. Exemplary formulations and methods within the invention utilize human growth hormone as the hormone.

L'invention concerne des formulations pharmaceutiques comprenant au moins une hormone de croissance et un ou plusieurs agents améliorant qui favorisent une meilleure administration de l'hormone de croissance par voie muqueuse nasale. Selon un aspect, les formulations et procédés d'administration intranasale offrent une meilleure administration de l'hormone de croissance au plasma sanguin, par exemple, en produisant une concentration de crête (C¿max?) de l'hormone de croissance dans une veine porte hépatique ou un plasma sanguin du patient qui représente au moins 20 % par rapport à une concentration de crête de l'hormone de croissance dans la veine porte hépatique ou le plasma sanguin du patient à la suite de l'administration audit patient d'une même concentration ou dose de l'hormone de croissance par injection sous-cutanée. L'invention concerne, par exemple, des formulations et des procédés utilisant comme hormone l'hormone de croissance humaine.

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