Combination and method including a visual marker for determining compliance with a medication regimen

Abstract

A method and combination including a visual marker for monitoring a patient to determine compliance with a medication regimen. An orally administrable medication composition is provided in combination with a visual marker. When the combination is orally ingested, the marker causes a coloration or discoloration of the oral and/or pharyngeal cavity of a subject. By visually observing the oral and/or pharyngeal cavity of the subject, one can determine whether medication has been ingested based upon the presence or absence of the coloration/discoloration.

1 . A method of monitoring the compliance of a patient in following a medication regimen, said method comprising the steps of: 
 providing in combination an orally administrable composition, which is part of a medication regimen, and at least one marker, said at least one marker being present in said combination in a form and sufficient amount to cause a contact coloration of at least a portion of a mucous membrane or buccal membrane of the oral and/or pharyngeal cavity of a patient following oral ingestion of said combination by said patient, the half-life of said at least one marker being comparable to the half-life of said composition;    visually observing the oral and/or pharyngeal cavity of said patient; and    determining the presence or absence of said contact coloration for determining whether said patient has ingested said combination in compliance with the medication regimen.    
   
   
       2 . The method of  claim 1  wherein said composition is a medication composition.  
   
   
       3 . The method of  claim 1  wherein said composition is a placebo composition.  
   
   
       4 . The method of  claim 1  wherein visually observing the oral and/or pharyngeal cavity of said patient to determine the presence or absence of contact coloration further comprises the step of directing natural light into the oral and/or pharyngeal cavity of said patient prior to observing the oral and/or pharyngeal cavity of said patient in order to directly observe said contact coloration.  
   
   
       5 . The method of  claim 1  wherein visually observing the oral and/or pharyngeal cavity of said patient to determine the presence or absence of contact coloration further comprises the step of directing an optimal exciting light into the oral and/or pharyngeal cavity of said patient prior to observing the oral and/or pharyngeal cavity of said patient in order to observe said contact coloration through fluorescence.  
   
   
       6 . The method of  claim 5  wherein said optimal exciting light is a violet-blue to blue light having a wavelength in a range of from about 430 nm to about 490 nm.  
   
   
       7 . The method of  claim 1  wherein visually observing said oral and/or pharyngeal cavity comprises visually observing a mucous membrane in said oral and/or pharyngeal cavity.  
   
   
       8 . The method of  claim 1  wherein said marker is carmine red dye.  
   
   
       9 . The method of  claim 1  wherein said marker is selected from the group consisting of indigo carmine, methylene blue, tartrazine, laccaic acid, beta-carotene, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 6, and riboflavin.  
   
   
       10 . The method of  claim 1  further comprising providing multiple markers in said combination.  
   
   
       11 . The method of  claim 10  wherein one of said multiple markers causes a different contact coloration in the portion of the oral and/or pharyngeal cavity than another of said markers.  
   
   
       12 . The method of  claim 1  further comprising providing multiple markers in said combination wherein one of said multiple markers causes a different contact coloration in the portion of the oral and/or pharyngeal cavity than another of said markers.  
   
   
       13 . The method of  claim 1  further comprising providing multiple markers in said combination, one of said markers causing a contact coloration of a portion of the oral and/or pharyngeal cavity detectable with natural light and another of said markers causing contact coloration detectable with a light which causes fluorescence.  
   
   
       14 . The method of  claim 1  further comprising providing multiple markers in said combination, the markers being detectable with a light which causes fluorescence, one of said markers causing a different fluorescent contact coloration of a portion of the oral and/or pharyngeal cavity than the fluorescent contact coloration caused by the other marker.  
   
   
       15 . In combination: 
 an orally administrable composition; and    at least one marker, said marker being present in said combination in a sufficient amount and form to cause a contact coloration of at least a portion of a mucous membrane or buccal membrane of the oral and/or pharyngeal cavity of a patient following ingestion of said combination by said patient, the half-life of said marker being comparable to the half-life of said composition;    said contact coloration of the oral and/or pharyngeal cavity being visually observable for determining whether said patient has ingested said combination in compliance with a medication regimen.    
   
   
       16 . The combination of  claim 15  wherein said at least one marker is applied to the outer surface of said composition.  
   
   
       17 . The combination of  claim 15  wherein said at least one marker is interspersed throughout said composition.  
   
   
       18 . The combination of  claim 15  wherein the form of said composition is selected from the group consisting of a chewable tablet, a pill, a capsule, and a liquid.  
   
   
       19 . The combination of  claim 15  wherein said marker is operable to cause contact coloration of a mucous membrane of said oral and/or pharyngeal cavity.  
   
   
       20 . The combination of  claim 15  wherein said at least one marker is carmine red dye.  
   
   
       21 . The combination of  claim 15  wherein said at least one marker is selected from the group consisting of indigo carmine, methylene blue, tartrazine, laccaic acid, beta-carotene, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 6, and riboflavin.  
   
   
       22 . The combination of  claim 15  further comprising multiple markers in said combination.  
   
   
       23 . The combination of  claim 22  wherein one of said multiple markers causes a different contact coloration in the portion of the oral and/or pharyngeal cavity than another of said markers.  
   
   
       24 . The combination of  claim 22  wherein one of said multiple markers causes a contact coloration of a portion of the oral and/or pharyngeal cavity detectable with natural light and another of said markers causes contact coloration detectable with a light which causes fluorescence.  
   
   
       25 . The combination of  claim 22  wherein the multiple markers are detectable with a light which causes fluorescence, one of said markers causing a different fluorescent contact coloration of a portion of the oral and/or pharyngeal cavity than the fluorescent contact coloration caused by the other marker.  
   
   
       26 . The method of  claim 1 , wherein said combination is in a form and sufficient amount to cause a contact coloration directly on at least a portion of a mucous membrane or buccal membrane of the oral and/or pharyngeal cavity.  
   
   
       27 . In combination: 
 an orally administrable composition; and    at least one marker, said marker being present in said combination in a sufficient amount and form to cause a contact coloration directly on at least a portion of a mucous membrane or buccal membrane of the oral and/or pharyngeal cavity of a patient following ingestion of said combination by said patient;    said contact coloration directly on the oral and/or pharyngeal cavity being visually observable for determining whether said patient has ingested said combination in compliance with a medication regimen.