INGESTIBLE DEVICE FOR DELIVERY OF THERAPEUTIC AGENT TO THE GASTROINTESTINAL TRACT
An ingestible device, includes a storage reservoir configured to store a dispensable substance and a pressurized chamber configured so that, when a restraining force is removed from the pressurized clamber, the dispensable substance exits the ingestible device via openings in the ingestible device.
1 - 788 . (canceled)
789 . A method of treating a patient comprising:
orally administering an ingestible device containing a dispensable substance to the patient;
the dispensable substance comprising a therapeutically effective amount of a pharmaceutical having a molecular weight of about 3 kDa to about 200 kDa;
the dispensable substance releasing from the ingestible device in the gastrointestinal tract of the patient as at least one jet, providing trans-epithelial delivery of the dispensable substance to the submucosa of the gastrointestinal tract of the patient.
790 . The method of claim 789 wherein the trans-epithelial administration provides systemic uptake of the pharmaceutical that is at least about 15% relative to intravenous or subcutaneous administration of an equal amount of the pharmaceutical.
791 . The method of claim 789 wherein the trans-epithelial administration provides an area under the curve (AUC) of the pharmaceutical in systemic circulation over time (AUCTE) that is at least about 10% of the AUC in systemic circulation over time provided by intravenous or subcutaneous administration of an equal amount of the pharmaceutical.
792 . The method of claim 789 wherein the trans-epithelial administration provides a maximum plasma concentration (Cmax) of the pharmaceutical in systemic circulation ((Cmax)TE) that is at least about 10% of the Cmax in systemic circulation provided by intravenous or subcutaneous administration of an equal amount of the pharmaceutical.
793 . The method of claim 789 wherein the dispensable substance is released in the small intestine.
794 . The method of claim 789 wherein the dispensable substance is released in the jejunum.
795 . The method of claim 789 wherein a volume of the dispensable substance released from the ingestible device is about 50 microliters to about 800 microliters.
796 . The method of claim 789 wherein a volume of the dispensable substance released from the ingestible device is about 250 microliters to about 400 microliters.
797 . The method of claim 789 wherein a compressed gas drives the dispensable substance through at least one nozzle to generate the at least one jet.
798 . The method of claim 797 wherein the at least one nozzle has a nozzle opening with a diameter of about 0.20 to 0.50 mm.
799 . The method of claim 789 wherein the dispensable substance has a molecular weight of about 60 kDa to about 200 kDa.
800 . The method of claim 789 wherein the at least one jet of the dispensable substance has an average jet velocity of about 10 m/s to about 50 m/s.
801 . The method of claim 789 wherein the dispensable substance comprises insulin.
802 . The method of claim 789 wherein the dispensable substance comprises adalimumab.
803 . The method of claim 789 wherein the dispensable substance comprises dulaglutide.
804 . The method of claim 789 wherein the dispensable substance comprises semaglutide.
805 . The method of claim 789 wherein the dispensable substance comprises liraglutide.
806 . A method of treating a disease or condition, comprising:
trans-epithelially administering a dispensable substance to the gastrointestinal tract of a patient by orally administering an ingestible device containing the dispensable substance to the patient;
the dispensable substance comprising a therapeutically effective amount of a pharmaceutical having a molecular weight of about 3 kDa to about 200 kDa; and
using a compressed gas to dispense the dispensable substance from the ingestible device in the gastrointestinal tract of the patient as at least one jet, providing trans-epithelial delivery of the dispensable substance directly to the submucosa of the gastrointestinal tract of the patient.
807 . The method of claim 806 wherein the trans-epithelial administration provides systemic uptake of the pharmaceutical that is at least about 15% relative to intravenous or subcutaneous administration of an equal amount of the pharmaceutical.
808 . The method of claim 806 wherein the trans-epithelial administration provides an area under the curve (AUC) of the pharmaceutical in systemic circulation over time (AUCTE) that is at least about 10% of the AUC in systemic circulation over time provided by intravenous or subcutaneous administration of an equal amount of the pharmaceutical.
809 . The method of claim 806 wherein the trans-epithelial administration provides a maximum plasma concentration (Cmax) of the pharmaceutical in systemic circulation ((Cmax)TE) that is at least about 10% of the Cmax in systemic circulation provided by intravenous or subcutaneous administration of an equal amount of the pharmaceutical.
810 . The method of claim 806 wherein a compressed gas drives the dispensable substance through at least one nozzle to generate the at least one jet.
811 . The method of claim 810 wherein the at least one nozzle has a nozzle opening with a diameter of about 0.20 to 0.50 mm.
812 . The method of claim 806 wherein the pharmaceutical has a molecular weight of about 60 to about 200 kDa.
813 . The method of claim 806 wherein the at least one jet of the dispensable substance has an average jet velocity of about 10 m/s to about 50 m/s.
814 . A method of treating a disease or condition, comprising:
trans-epithelially administering a dispensable substance to the gastrointestinal tract of a patient by orally administering an ingestible device containing the dispensable substance to the patient;
the dispensable substance comprising a therapeutically effective amount of a pharmaceutical having a molecular weight of about 3 kDa to about 160 kDa;
using a compressed gas to dispense the dispensable substance from the ingestible device in the gastrointestinal tract of the patient as at least one jet, providing trans-epithelial delivery of the dispensable substance directly to the submucosa of the gastrointestinal tract of the patient;
wherein the trans-epithelial administration provides systemic uptake of the pharmaceutical that is at least about 15% relative to intravenous or subcutaneous administration of an equal amount of the pharmaceutical.
815 . The method of claim 814 wherein a compressed gas drives the dispensable substance through a nozzle to generate the at least one jet.
816 . The method of claim 815 wherein the nozzle has a nozzle opening with a diameter of about 0.20 to 0.50 mm.
817 . The method of claim 814 wherein the at least one jet of the dispensable substance has an average jet velocity of about 10 m/s to about 50 m/s.