Pharmaceutical product and method of making

Abstract

A substrate is robotically picked up at a station and transported to a measuring station to measure the distance to a reference. The substrate is aligned to a robot before measurement. The measured substrate is then transported to a pharmaceutical or diagnostic powder/grain deposition station where the powder/grains are controllably deposited on the substrate to predetermined thicknesses over a plurality of powder/grain collection zones. The deposited powder/grains are then measured to determine the thickness and area covered by the deposited powder/grains at each collection zone. The substrate is then transported to a lamination station and each collection zone of powder/grains is welded to a cover substrate. The system remembers which collection zones are out of specification so that they can be later selectively discarded.

What is claimed is:  
     
         1 . A product comprising: 
 a package; and    a plurality of pharmaceutical or diagnostic unit dosage forms associated with the package, each unit dosage form including at least one active ingredient, said at least one active ingredient being present in each of the unit forms in an amount which does not vary from a predetermined amount by more than about 5%.    
     
     
         2 . The product of    claim 1    wherein the package comprises a container and the unit forms are physically separate and independent from one another.  
     
     
         3 . The product of    claim 1    wherein the unit forms are selected from the group consisting of any one of a tablet, caplet, a unit amount of an active drug powder and a capsule.  
     
     
         4 . The product of    claim 1    wherein each of the unit forms are solid.  
     
     
         5 . The product of    claim 1    wherein the unit forms are attached to laminated strips of substrate films.  
     
     
         6 . A method of forming a drug dosage or diagnostic product comprising forming a plurality of pharmaceutical or diagnostic unit dosage forms, each unit form including at least one active ingredient, said at least one active ingredient being present in each of the unit forms in an amount which does not vary from a predetermined amount by more than about 5%.  
     
     
         7 . The method of    claim 6    including laser scanning the unit forms in a raster scan to produce scan signals and calculating the amount of active ingredient in each unit form from the scan signals.  
     
     
         8 . The method of    claim 7    wherein the scanning employs optical profilometry to produce said signals.  
     
     
         9 . The method of    claim 7    wherein the scanning employs diffuse reflection to produce said signals.  
     
     
         10 . A method of making a plurality of pharmaceutical unit dosage or diagnostic dosage forms each containing at least one pharmaceutically or diagnostic active ingredient comprising non-destructively testing for the presence of the amount of the at least one active ingredient in each of the forms to determine whether the amount of active ingredient is present in a predetermined acceptable amount.  
     
     
         11 . The method of    claim 10    including the step of determining the amount of said at least one active ingredient in each said unit forms during the manufacturing thereof.  
     
     
         12 . The method of    claim 10    including selectively discarding the unit form when the determined value of the deposited active ingredient exceeds or is less than a predetermined range of values.  
     
     
         13 . The method of    claim 10    wherein the non-destructively testing includes calculating the amount of the at least one active ingredient in each unit form.  
     
     
         14 . The method of    claim 13    wherein the non-destructively testing includes measuring the thickness and area of the at least one active ingredient on a substrate corresponding to each unit form.  
     
     
         15 . The method of    claim 14    wherein the non-destructively testing includes dividing said unit forms into a plurality of subgroups of unit forms and then discarding the unit forms of a selected subgroup a member of which is beyond the predetermined acceptable amount.  
     
     
         16 . The method of    claim 10    wherein the predetermined acceptable amount does not vary more than about 5% from a given value.  
     
     
         17 . A product comprising: 
 a package; and    a plurality of diagnostic or pharmaceutically active unit dosage forms associated with the package, each unit form including at least one diagnostic or pharmaceutically active ingredient, said at least one active ingredient being present in each of the unit dosage forms in an amount which does not vary from a given amount by more than a predetermined value.    
     
     
         18 . The product of    claim 17    wherein the predetermined value is about 5%.  
     
     
         19 . A diagnostic reagent kit comprising a plurality of separate unit forms of a diagnostic reagent each unit form comprising a diagnostic reagent deposited on a substrate wherein the amount of diagnostic reagent in each unit form does not vary from a predetermined amount by more than 5%.  
     
     
         20 . The kit of    claim 19    including non-destructively screening each of the unit forms for the amount of reagent in each unit form.