Methods for pulmonary delivery of interleukin-2
AssigneeChiron Corporation
InventorsBao-Lu Chen, Maninder Hora
Life of this patent
Estimating the term…
Abstract
Methods for administering interleukin-2 (IL-2) or variants thereof via pulmonary inhalation are provided. The methods comprise preparing a pharmaceutical composition comprising IL-2 or variants thereof for subsequent delivery as an aqueous or nonaqueous solution or suspension or a dry powder form. These compositions may further comprise a surfactant in an amount sufficient to enhance absorption of the composition following pulmonary inhalation of the composition. When used in the delivery methods of the invention, these highly absorbable compositions result in enhanced bioavailability of IL-2.
Claims50
A method for administering IL-2 to a subject in need thereof, said method comprising
- a) obtaining a pharmaceutical composition comprising stabilized monomeric IL-2 or variants thereof;
- b) preparing said composition as an aqueous or nonaqueous solution, an aqueous or nonaqueous suspension, or a dry powder form;
- and
- c) delivering said solution, suspension, or dry powder form of said composition to said subject by pulmonary inhalation.
A method for administering IL-2 to a subject in need thereof, said method comprising:
- a) obtaining a highly absorbable pharmaceutical composition comprising monomeric IL-2 or variants thereof, wherein said composition comprises at least one surfactant in an amount sufficient to enhance absorption of said composition following pulmonary inhalation of said composition;
- b) preparing said composition as an aqueous or nonaqueous solution, an aqueous or nonaqueous suspension, or a dry powder form;
- and
- c) delivering said solution, suspension, or dry powder form of said composition to said subject by pulmonary inhalation.
A method for administering IL-2 to a subject in need thereof, said method comprising
- a) obtaining a pharmaceutical composition comprising multimeric IL-2 or variants thereof;
- b) preparing said composition as an aqueous or nonaqueous solution, an aqueous or nonaqueous suspension, or a dry powder form;
- and
- c) delivering said solution, suspension, or dry powder form of said composition to said subject by pulmonary inhalation.
A method for administering IL-2 to a subject in need thereof, said method comprising
- a) obtaining a pharmaceutical composition comprising a stabilized lyophilized or spray-dried IL-2 or variants thereof;
- b) preparing said composition as an aqueous or nonaqueous solution, an aqueous or nonaqueous suspension, or a dry powder form;
- and
- c) delivering said solution, suspension, or dry powder form of said composition to said subject by pulmonary inhalation.
A method for enhancing bioavailability of IL-2 administered to a subject via pulmonary inhalation, said method comprising administering a pharmaceutical composition comprising stabilized monomeric IL-2 or variants thereof to said subject via pulmonary inhalation.
A method for enhancing bioavailability of IL-2 administered to a subject via pulmonary inhalation, said method comprising administering a highly absorbable pharmaceutical composition comprising monomeric IL-2 or variants thereof to said subject via pulmonary inhalation, wherein said composition comprises at least one surfactant in an amount sufficient to enhance absorption of said composition following pulmonary inhalation of said composition.
A method for enhancing bioavailability of IL-2 administered to a subject via pulmonary inhalation, said method comprising administering a pharmaceutical composition comprising multimeric IL-2 or variants thereof to a subject via pulmonary inhalation, wherein said composition comprises at least one surfactant in an amount sufficient to enhance absorption of said composition following pulmonary inhalation of said composition.
A method for enhancing bioavailability of IL-2 administered to a subject via pulmonary inhalation, said method comprising administering a pharmaceutical composition comprising stabilized lyophilized or spray-dried IL-2 or variants thereof to a subject via pulmonoary inhalation, wherein said composition comprises at least one surfactant in an amount sufficient to enhance absorption of said composition following pulmonary inhalation of said composition.
A stabilized lyophilized or spray-dried pharmaceutical composition comprising:
- interleukin-2 (IL-2) as a therapeutically active component;
- at least one bulking agent present at about 0% to about 5%;
- at least one of a sugar selected from the group consisting of sucrose, trehalose, raffinose, stachyose, sorbitol or at least one of an amino acid selected from the group consisting of arginine and lysine, wherein said sugar is present at about 0% to about 9%, and wherein said amino acid is present at about 0% to about 1%;
- and
- a buffering agent to maintain said composition at a pH of about pH 4.0 to about pH 8.5 when said composition is reconstituted as a liquid.
A pharmaceutical composition comprising interleukin-2 (IL-2) or variants thereof as a therapeutic agent, wherein said composition comprises at least one surfactant in an amount sufficient to enhance absorption of said composition following pulmonary inhalation of said composition.
Dependencies are inferred from the claim text.