Delivery of active agents
First Claim
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1. A method of providing a labile peptide hormone to a patient in need thereof comprising:
- administering a suitable pharmaceutical composition comprising microparticles produced from formulation of a diketopiperazine with the labile peptide hormone by pulmonary inhalation;
wherein said labile peptide hormone is subject to degradation in said patient as a result of exposure of said agent to peripheral tissue, vascular venous tissue, or the liver, prior to reaching the agent'"'"'s site of action, wherein the effectiveness of said labile peptide hormone is reduced by said degradation;
wherein said labile peptide hormone is not GLP-1 or insulin; and
wherein about 35% to about 75% of said microparticles have an aerodynamic diameter of less than 5.8 micrometer for said pulmonary inhalation; and
further, wherein the pulmonary inhalation results in a greater therapeutic effect from a lower exposure of said labile peptide hormone than oral, subcutaneous and intravenous administration of said labile peptide hormone.
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Abstract
A method of introducing a physiologically-active agent into the circulatory system of a mammal is disclosed herein. The method utilizes a rapid drug delivery system which prevents deactivation or degradation of the active agent being administered to a patient in need of treatment. In particular, the drug delivery system is designed for pulmonary drug delivery such as by inhalation, for delivery of the active agents such as proteins and peptides to the pulmonary circulation in a therapeutically effective manner avoiding degradation of the active agents in peripheral and vascular tissue before reaching the target site.
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Citations
21 Claims
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1. A method of providing a labile peptide hormone to a patient in need thereof comprising:
- administering a suitable pharmaceutical composition comprising microparticles produced from formulation of a diketopiperazine with the labile peptide hormone by pulmonary inhalation;
wherein said labile peptide hormone is subject to degradation in said patient as a result of exposure of said agent to peripheral tissue, vascular venous tissue, or the liver, prior to reaching the agent'"'"'s site of action, wherein the effectiveness of said labile peptide hormone is reduced by said degradation;
wherein said labile peptide hormone is not GLP-1 or insulin; and
wherein about 35% to about 75% of said microparticles have an aerodynamic diameter of less than 5.8 micrometer for said pulmonary inhalation; and
further, wherein the pulmonary inhalation results in a greater therapeutic effect from a lower exposure of said labile peptide hormone than oral, subcutaneous and intravenous administration of said labile peptide hormone. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
- administering a suitable pharmaceutical composition comprising microparticles produced from formulation of a diketopiperazine with the labile peptide hormone by pulmonary inhalation;
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13. A method of treating a disease comprising:
- administering by pulmonary inhalation to a patient with a condition treatable by a labile peptide hormone a pharmaceutical composition comprising said peptide hormone which has been formulated into microparticles comprising a diketopiperazine and said peptide hormone, wherein the pharmaceutical composition is suitable for said pulmonary inhalation, wherein said labile peptide hormone is not GLP-1 or insulin; and
wherein about 35% to about 75% of said microparticles have an aerodynamic diameter of less than 5.8 micrometer for said pulmonary inhalation, and wherein the pulmonary inhalation results in a greater therapeutic effect from a lower exposure of said labile peptide hormone than oral, subcutaneous and intravenous administration of said labile peptide hormone. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20, 21)
- administering by pulmonary inhalation to a patient with a condition treatable by a labile peptide hormone a pharmaceutical composition comprising said peptide hormone which has been formulated into microparticles comprising a diketopiperazine and said peptide hormone, wherein the pharmaceutical composition is suitable for said pulmonary inhalation, wherein said labile peptide hormone is not GLP-1 or insulin; and
Specification