Pharmaceutical Product and Method of Analysing Light Exposure of a Pharmaceutical Product

Abstract

A pharmaceutical product includes a container having an exterior surface and an interior chamber, an active ingredient disposed in the interior chamber, the active ingredient having a photosensitive property that changes based on at least cumulative exposure to light having a wavelength within the range between X and Y, and a layer of photosensitive material disposed on or in the container and exposed to environmental conditions contemporaneous with the active ingredient being disposed in the interior chamber. The photosensitive material is reactive to light having a wavelength within the range between X and Y to experience a property change at a threshold of cumulative exposure to light received within the range between X and Y related to the change in the photosensitive property of the active ingredient. A photosensitive device can also be disposed along a path followed by the pharmaceutical product within a facility.

1 . A pharmaceutical product comprising:
 a container having an exterior surface and an interior chamber;   an active ingredient disposed in the interior chamber, the active ingredient having a photosensitive property that changes based on at least cumulative exposure to light having a wavelength within the range between X and Y; and   a layer of photosensitive material disposed on the exterior surface of the container and exposed to environmental conditions contemporaneous with the active ingredient being disposed in the interior chamber,   the photosensitive material reactive to light having a wavelength within the range between X and Y to experience a property change at a threshold of cumulative exposure to light received within the range between X and Y related to the change in the photosensitive property of the active ingredient.   
     
     
         2 - 3 . (canceled) 
     
     
         4 . The product according to  claim 1 , further comprising a layer of removable photo-resistive material applied over the layer of photosensitive material. 
     
     
         5 . The product according to  claim 4 , wherein the layer of removable photo-resistive material comprises a label removably attached to the exterior surface of the container over the layer of photosensitive material. 
     
     
         6 . The product according to  claim 1 , wherein the property change of the photosensitive material in the layer on the exterior surface of the container is a colorimetrically detectable property change. 
     
     
         7 . The product according to  claim 1 , wherein the active ingredient is a polypeptide, amino acid, or small molecule. 
     
     
         8 . The product according to  claim 7 , wherein the polypeptide is a monoclonal antibody polypeptide, and the photosensitive property change comprises at least one of an increase in an amount of high molecular weight species present in the active ingredient, an increase in an amount of low molecular weight species present in the active ingredient, a colorimetrically detectable property change, and a change in an amount of charged species present in the active ingredient. 
     
     
         9 - 14 . (canceled) 
     
     
         15 . The product according to  claim 7 , wherein the active ingredient is a small molecule, and the photosensitive property change comprises at least one of a change in light absorbance and a yellow-index color change. 
     
     
         16 - 17 . (canceled) 
     
     
         18 . The product according to  claim 1 , wherein the active ingredient is a virus. 
     
     
         19 . The product according to  claim 1 , wherein the active ingredient is a diagnostic reagent. 
     
     
         20 . The product according to  claim 1 , wherein the range is between 190 to 1100 nm, between 315 to 400 nm, or between 401 to 750 nm. 
     
     
         21 - 22 . (canceled) 
     
     
         23 . A pharmaceutical product comprising:
 a container having an interior chamber, the container constructed from a material that is photo-resistive;   an active ingredient disposed in the interior chamber, the active ingredient having a photosensitive property that changes based on at least cumulative exposure to light having a wavelength within the range between X and Y; and   a layer of photosensitive material disposed in the interior chamber of the container,   the photosensitive material reactive to light having a wavelength within the range between X and Y to experience a property change at a threshold of cumulative exposure to light received within the range between X and Y related to the change in the photosensitive property of the active ingredient.   
     
     
         24 . The product according to  claim 23 , wherein the property change of the photosensitive material in the layer disposed in the interior chamber of the container is a colorimetrically detectable property change. 
     
     
         25 . The product according to  claim 23 , wherein the active ingredient is a polypeptide, amino acid or small molecule. 
     
     
         26 . The product according to  claim 23 , wherein the active ingredient is a virus. 
     
     
         27 . The product according to  claim 23 , wherein the active ingredient is a diagnostic reagent. 
     
     
         28 - 30 . (canceled) 
     
     
         31 . The product according to  claim 25 , wherein the polypeptide is a monoclonal antibody polypeptide, and the photosensitive property change comprises at least one of an increase in an amount of high molecular weight species present in the active ingredient, an increase in an amount of low molecular weight species present in the active ingredient, a colorimetrically detectable property change, and a change in an amount of charged species present in the active ingredient. 
     
     
         32 . The product according to  claim 31 , wherein the antibody polypeptide is a monoclonal antibody polypeptide. 
     
     
         33 . The product according to  claim 32 , wherein the photosensitive property change comprises an increase in an amount of high molecular weight species present in the active ingredient. 
     
     
         34 . The product according to  claim 32 , wherein the photosensitive property change comprises an increase in an amount of high molecular weight species present in the active ingredient. 
     
     
         35 . The product according to  claim 32 , wherein the photosensitive property change is a colorimetrically detectable property change. 
     
     
         36 . The product according to  claim 35 , wherein the photosensitive property change comprises a yellow-index color change. 
     
     
         37 . The product according to  claim 32 , wherein the photosensitive property change comprises a change in an amount of charged species present in the active ingredient. 
     
     
         38 . The product according to  claim 25 , wherein the active ingredient is a small molecule, and the photosensitive property change comprises at least one of a change in light absorbance and a yellow-index color change. 
     
     
         39 - 42 . (canceled) 
     
     
         43 . The product according to  claim 23 , wherein the range is between 190 to 1100 nm, between 315 to 400 nm, or between 401 to 750 nm. 
     
     
         44 - 45 . (canceled) 
     
     
         46 . A method of confirming correct handling of photo-sensitive material, comprising:
 applying a layer of photosensitive material to an exterior surface of a container having an active ingredient disposed therein, the active ingredient having a photosensitive property that changes based on at least cumulative exposure to light having a wavelength within the range between X and Y and the photosensitive material reactive to light having a wavelength within the range between X and Y to experience a property change at a threshold of cumulative exposure to light received within the range between X and Y related to the change in the photosensitive property of the active ingredient;   delivering the container to a recipient;   collecting the container from the recipient;   examining the layer of photosensitive to determine if the photosensitive material has experienced the property change; and   identifying the container as mishandled if the photosensitive materials has experienced the property change.   
     
     
         47 . (canceled) 
     
     
         48 . The method according to  claim 46 , wherein the active ingredient is a polypeptide, amino acid, or small molecule. 
     
     
         49 . The method according to  claim 48 , wherein the polypeptide is a monoclonal antibody polypeptide, and the photosensitive property change comprises at least one of an increase in an amount of high molecular weight species present in the active ingredient, an increase in an amount of low molecular weight species present in the active ingredient, a colorimetrically detectable property change, and an amount of charged species present in the active ingredient. 
     
     
         50 - 55 . (canceled) 
     
     
         56 . The method according to  claim 48 , wherein the active ingredient is a small molecule, and the photosensitive property change comprises at least one of a change in light absorbance and a yellow-index color change. 
     
     
         57 - 58 . (canceled) 
     
     
         59 . The method according to  claim 46 , wherein the active ingredient is a virus. 
     
     
         60 . The method according to  claim 46 , wherein the active ingredient is a diagnostic reagent. 
     
     
         61 . The method according to  claim 46 , wherein the range is between 190 to 1100 nm, between 315 to 400 nm, or between 401 to 750 nm. 
     
     
         62 - 63 . (canceled) 
     
     
         64 . A method of analyzing light exposure of a pharmaceutical product, comprising:
 identifying a path for the pharmaceutical product within a facility comprising at least one space through which the pharmaceutical product passes, the pharmaceutical product comprising an active ingredient having a photosensitive property that changes based on at least cumulative exposure to light having a wavelength within the range between X and Y;   disposing at least one photosensitive device along the path, the at least one photosensitive device comprising a layer of photosensitive material reactive to light having a wavelength within the range between X and Y to experience a property change at a threshold of cumulative exposure to light received within the range between X and Y;   reading the at least one photosensitive device after being disposed along the path for evidence of the property change to the photosensitive material of the photosensitive device; and   changing the path for the pharmaceutical product through the facility if the property change occurs to the photosensitive material of the photosensitive device.   
     
     
         65 . The method according to  claim 64 , wherein the facility is a manufacturing facility. 
     
     
         66 . The method according to  claim 64 , wherein reading the at least one photosensitive device being disposed along the path comprises disposing an optical sensing device proximate to the photosensitive device, the optical sensing device coupled to a computing device that displays an indication of light exposure experienced by the at least one photosensitive device. 
     
     
         67 . (canceled) 
     
     
         68 . The method according to  claim 64 , wherein the active ingredient is a polypeptide, amino acid, or small molecule. 
     
     
         69 . The method according to  claim 68 , wherein the polypeptide is a monoclonal antibody polypeptide, and the photosensitive property change comprises at least one of an increase in an amount of high molecular weight species present in the active ingredient, an increase in an amount of low molecular weight species present in the active ingredient, a colorimetrically detectable property change, and an amount of charged species present in the active ingredient. 
     
     
         70 . The method according to  claim 69 , wherein the antibody polypeptide is a monoclonal antibody polypeptide. 
     
     
         71 . The method according to  claim 70 , wherein the photosensitive property change comprises an increase in an amount of high molecular weight species present in the active ingredient. 
     
     
         72 . The method according to  claim 70 , wherein the photosensitive property change comprises an increase in an amount of low molecular weight species present in the active ingredient. 
     
     
         73 . The method according to  claim 70 , wherein the photosensitive property change is a colorimetrically detectable property change. 
     
     
         74 . The method according to  claim 73 , wherein the photosensitive property change comprises a yellow-index color change. 
     
     
         75 . The method according to  claim 70 , wherein the photosensitive property change comprises a change in an amount of charged species present in the active ingredient. 
     
     
         76 . The method according to  claim 68 , wherein the active ingredient is a small molecule, and the photosensitive property change comprises at least one of a change in light absorbance and a yellow-index color change. 
     
     
         77 - 78 . (canceled) 
     
     
         79 . The method according to  claim 64 , wherein the active ingredient is a virus. 
     
     
         80 . The method according to  claim 64 , wherein the active ingredient is a diagnostic reagent. 
     
     
         81 . The method according to  claim 64 , wherein the range is between 190 to 1100 nm, between 315 to 400 nm, or between 401 to 750 nm. 
     
     
         82 - 83 . (canceled)