Stabilizing catheter for protein drug delivery

A - Human Necessities – 61 – M

Patent

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Details

A61M 5/00 (2006.01) A61L 29/16 (2006.01)

Patent

CA 2457538

Stabilizing catheters for delivery of one or more protein drugs to a patient. The stabilizing catheter embodiments of the invention maintain or preserve a biologically/pharmacologically active form of the protein drug for delivery to a site within the body. Particular embodiments include a tubing layered with a hydrophilic and mobile polymer that aids in the maintenance or preservation of an active conformer of the protein drug. These embodiments of the stabilizing catheter prevent site loss of protein drugs, such as insulin. Other embodiments include a tubing that is layered with a material that substantially prevents diffusion of small, insulin formulation-stabilizing molecules out from the catheter, as well as substantially prevents the diffusion of small, insulin formulation-destabilizing molecules into the catheter, during a period of insulin infusion. In effect, these embodiments of the stabilizing catheter maintain the stabilizing effect of a particular insulin formulation, and consequently, substantially prevents occlusions/deposits from being formed during a period set for insulin delivery. Still other embodiments are directed to a combination of these features of the stabilizing catheters of the invention.

L'invention concerne des cathéters de stabilisation pour l'administration de protéine(s)-médicament(s) à un patient. Selon les variantes décrites dans l'invention, il s'agit de cathéters maintenant ou préservant une forme biologiquement/pharmacologiquement active de protéine-médicament, aux fins d'administration sur un site corporel. Selon des variantes spécifiques, les cathéters comportent un tubage à couche de polymère hydrophile et mobile qui contribue au maintien ou à la préservation d'un conformère actif de la protéine-médicament. Dans une telle configuration, les cathéters empêchent la perte de protéine-médicament (par exemple, insuline) sur le site d'administration. Selon d'autres variantes, le tubage comporte une couche de matériau empêchant sensiblement la diffusion de petites molécules de stabilisation de formulation d'insuline hors du cathéter, et empêchant sensiblement la pénétration de petites molécules de déstabilisation de formulation d'insuline dans le cathéter, durant une période de perfusion d'insuline. Dans tous les cas, ces cathéters maintiennent l'effet stabilisateur d'une formulation d'insuline spécifique, et empêchent donc sensiblement la formation des occlusions/dépôts durant une période d'administration d'insuline. D'autres variantes encore présentent une combinaison des caractéristiques décrites.

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