Devices and methods for monitoring drug therapy compliance

• US 6,663,846 B1
• Filed: 12/21/1999
• Issued: 12/16/2003
• Est. Priority Date: 12/21/1998
• Status: Expired due to Term

• Current Assignee: University of Maryland Baltimore County (University of Maryland)
• Original Assignee: Candace Mccombs, Joseph R. Lakowicz, Omoefe Abugo, Zygmunt Gryczynski
• Inventors: Gryczynski, Zygmunt, Lakowicz, Joseph R., McCombs, Candace, Abugo, Omoefe
• Primary Examiner(s): Hartley, Michael G.
• Application Number:
  US09/468,718
• Time in Patent Office: 1,456 Days
• Field of Search: 424/9.2, 424/9.6, 424/9.8, 424/9.1, 600/300, 600/317, 600/306
• US Class Current: 424/9.2
• CPC Class Codes: A61B 5/0071 by measuring fluorescence emission
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61K 49/0034 Indocyanine green, i.e. ICG, cardiogreen
• CPC Class Codes: A61K 49/0041 Xanthene dyes, used in vivo, e.g. administered to a mice, e.g. rhodamines, rose Bengal in vivo G01N
• CPC Class Codes: A61K 49/0063 characterised by a special physical or galenical form, e.g. emulsions, microspheres
• CPC Class Codes: A61K 49/0082 micelle, e.g. phospholipidic micelle and polymeric micelle
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Methods and compositions for the detection and monitoring of drug therapy are provided. In particular, efficient and sensitive methods for the detection of drug ingestion are provided for determining whether individuals are complying with prescribed therapeutic regimens, and for providing a mechanism for identifying drug-resistant strains of infectious agents. The claimed methods and compositions involve the application of transdermal devices containing detection mechanisms for receiving and recording signals generated by the ingestion of a labeled drug. Such devices are attached to the skin for the duration of drug therapy and compliance is determined either by direct reading, or by remote monitoring whereby signals are transmitted from the device and received at an external site such as a healthcare facility.

Claims

1. A method for monitoring drug therapy compliance by a human or animal patient, comprising contacting the patient with a transdermal detection device capable of receiving a signal from a labeled pill administered to the patient, wherein transdermal detection of the signal indicates that the patient has received a predetermined amount of the labeled pill.

2. The method of claim 1, wherein the pill is labeled with a fluorescent label, and the transdermal detection device detects a fluorescent signal emitted from the fluorescent label in the patient.

3. The method of claim 2, wherein the fluorescent label comprises one or more compounds selected from the group consisting of fluorescein, indocyanin green, and rhodamine B.

4. The method of claim 1, wherein the labeled pill comprises a drug selected from the group consisting of an antimicrobial agent, antibiotic, antiviral, antidepressant, β

-lactam antibiotic, aminoglycoside, macrolide, lincomycin, clindamycin, tetracycline, quinolone, polypeptide, sulfonamide, trimethoprim, sulfamethoxazole, growth factor, lipid, neurotransmitter, vitamin, and mineral.

5. The method of claim 1, wherein the pill is administered to treat a disease or disorder selected from the group consisting of infectious disease, immunodeficiency disease, cardiovascular disorder, pulmonary disorder, gastrointestinal disorder, hepatic disorder, biliary disorder, endocrine disorder, cancer, musculoskeletal disorder, connective tissue disorder, neurologic disorder, psychiatric disorder and genitourinary disorder.

6. The method of claim 5, wherein the infectious disease comprises mycobacterial disease.

7. The method of claim 6, wherein the mycobacterial disease is caused by infection with a Mycobacterial strain selected from the group consisting of Mycobacterium tuberculosis, Mycobacterium avium-intracellular, Mycobacterium kansasii, Mycobacterium frotiutun, Mycobacterium chelonae, and Mycobacterium leprae.

8. The method of claim 5, wherein the infectious disease is tuberculosis.

9. The method of claim 5, wherein the psychiatric disorder is a substance abuse disorder.

10. A method for monitoring drug therapy compliance in a patient being treated for substance abuse comprising contacting the patient with a transdermal detection device capable of receiving a signal from a labeled pill administered to the patient, wherein transdermal detection of the signal indicates that the patient has received a predetermined amount of the labeled drug.