Methods and devices for desmopressin drug delivery
First Claim
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1. A device for modulating urine production in a patient, the device comprising:
- (a) a depot containing a solution of desmopressin in a pharmaceutically acceptable carrier;
(b) an interface member in fluid communication with the depot for application to the skin of a patient;
(c) means for delivering the desmopressin solution from the depot to the interface member and intradermally or transdermally to the blood of a patient at a flux rate;
(i) sufficient to establish and maintain a desmopressin concentration in the blood of the patient within the range of about 0.2 to 5 pg/ml and(ii) insufficient to induce a desmopressin concentration in the blood of the patient greater than about 5 pg/ml;
wherein the desmopressin solution is formulated for transdermal delivery and the interface member comprises a desmopressin solution-permeable membrane for contact with the skin of the patient; and
wherein the means for delivering comprises pressure exerting means for impelling the solution at a predetermined rate from the depot to the interface member.
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Abstract
Disclosed are devices for urine voiding postponement, and methods for treating conditions such as central diabetes insipidus, enuresis, nocturia, urinary frequency or incontinence. The devices deliver a desmopressin flux through the skin of a patient in a low dose amount just necessary to achieve a desired anti-diuretic effect without undesirable side effects such as hyponatremia. The devices are designed to permit a state of normal urinary production to return quickly after the desmopressin flux is terminated.
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Citations
18 Claims
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1. A device for modulating urine production in a patient, the device comprising:
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(a) a depot containing a solution of desmopressin in a pharmaceutically acceptable carrier; (b) an interface member in fluid communication with the depot for application to the skin of a patient; (c) means for delivering the desmopressin solution from the depot to the interface member and intradermally or transdermally to the blood of a patient at a flux rate; (i) sufficient to establish and maintain a desmopressin concentration in the blood of the patient within the range of about 0.2 to 5 pg/ml and (ii) insufficient to induce a desmopressin concentration in the blood of the patient greater than about 5 pg/ml;
wherein the desmopressin solution is formulated for transdermal delivery and the interface member comprises a desmopressin solution-permeable membrane for contact with the skin of the patient; andwherein the means for delivering comprises pressure exerting means for impelling the solution at a predetermined rate from the depot to the interface member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A device for modulating urine production in a patient, the device comprising:
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(a) a depot containing a solution of desmopressin in a pharmaceutically acceptable carrier; (b) an interface member in fluid communication with the depot for application to the skin of a patient; (c) means for delivering the desmopressin solution from the depot to the interface member and intradermally or transdermally to the blood of a patient at a first, higher flux rate; (i) sufficient to establish and maintain a desmopressin concentration in the blood of the patient within the range of about 0.2 to 5 pg/ml and (ii) insufficient to induce a desmopressin concentration in the blood of the patient greater than about 5 pg/ml; and a second, lower flux rate to maintain the desmopressin concentration in the blood of the patient; and wherein the desmopressin solution is formulated for transdermal delivery and the interface member comprises a desmopressin solution-permeable membrane for contact with the skin of the patient. - View Dependent Claims (12, 13, 14, 16, 17, 18)
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15. A device for modulating urine production in a patient, the device comprising:
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(a) a depot containing a solution of desmopressin in a pharmaceutically acceptable carrier; (b) an interface member in fluid communication with the depot for application to the skin of a patient; (c) means for delivering the desmopressin solution from the depot to the interface member and intradermally or transdermally to the blood of a patient at a first, higher flux rate; (i) sufficient to establish and maintain a desmopressin concentration in the blood of the patient within the range of about 0.2 to 5 pg/ml and (ii) insufficient to induce a desmopressin concentration in the blood of the patient greater than about 5 pg/ml; and a second, lower flux rate to maintain the desmopressin concentration in the blood of the patient, wherein the means for delivering comprises a volume of the solution in contact with a surface of the interface member distal to a surface for contact with the skin of the patient, and the desmopressin flux is established by absorptive flow of the solution into the interface member and diffusion from the interface member through the skin of the patient.
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Specification