Packaged film dosage unit containing a complexate

Abstract

The present invention relates to packaged orally consumable film dosage units for delivery of actives into the oral cavity. In particular, the packaged pharmaceutical product contains a complexate including a complexing agent and an active, an orally consumable film for delivery of the complexate and a package for containing the orally consumable film. The package includes indicia associated therewith. The indicia identifies the complexate as the active ingredient contained in the film, which is as a regulatory approvable chemical entity. The present invention also relates to methods of labeling, pricing, marketing and satisfying governmental regulations for such packaged pharmaceutical products.

What is claimed is: 
     
         1 . A packaged pharmaceutical product comprising:
 a complexate comprising a complexing agent and an active;   an orally consumable film for delivery of said complexate; and   a package for containing said orally consumable film, said package comprising indicia associated therewith identifying said complexate as a regulatory approvable chemical entity.   
     
     
         2 . The pharmaceutical product of  claim 1 , wherein said active comprises a charged active. 
     
     
         3 . The pharmaceutical product of  claim 1 , wherein said complexing agent comprises an anionic complexing agent. 
     
     
         4 . The pharmaceutical product of  claim 1 , wherein said complexing agent comprises a cationic complexing agent. 
     
     
         5 . The pharmaceutical product of  claim 2 , wherein said charged active comprises an anionic active. 
     
     
         6 . The pharmaceutical product of  claim 2 , wherein said charged active comprises a cationic active. 
     
     
         7 . The pharmaceutical product of  claim 1 , wherein said complexing agent comprises a multi-valent salt. 
     
     
         8 . The pharmaceutical product of  claim 1 , wherein said complexing agent comprises a zeolite. 
     
     
         9 . The pharmaceutical product of  claim 1 , wherein said complexing agent comprises an ion exchange resin. 
     
     
         10 . The pharmaceutical product of  claim 1 , wherein said complexing agent comprises a caged molecule. 
     
     
         11 . The pharmaceutical product of  claim 10 , wherein said caged molecule comprises a cyclodextrin. 
     
     
         12 . The pharmaceutical product of  claim 1 , wherein said package comprises a pouch. 
     
     
         13 . The pharmaceutical product of  claim 1 , wherein said package comprises a box. 
     
     
         14 . The pharmaceutical product of  claim 1 , wherein said package comprises a cassette. 
     
     
         15 . The pharmaceutical product of  claim 1 , wherein said indicia comprises a label. 
     
     
         16 . The pharmaceutical product of  claim 15 , wherein said label is located on said package. 
     
     
         17 . The pharmaceutical product of  claim 15 , wherein said label is affixed to said package. 
     
     
         18 . The pharmaceutical product of  claim 1 , wherein said indicia comprises a list of active ingredients. 
     
     
         19 . The pharmaceutical product of  claim 1 , wherein said indicia identifies said complexate as an active ingredient. 
     
     
         20 . A method of labeling a packaged pharmaceutical product in a manner that is consistent with governmental drug regulations, comprising the steps of:
 (a) providing a packaged pharmaceutical product comprising:
 (i) a complexate comprising a complexing agent and a pharmaceutical active; 
 (ii) an orally consumable film for delivery of said complexate; and 
 (iii) a package for containing said orally consumable film; 
   (b) adding indicia to said package, said indicia comprising a list of active ingredients contained in said orally consumable film and a list of inactive ingredients contained in said orally consumable film, wherein said complexate is listed as an active ingredient.   
     
     
         21 . The method of  claim 20 , wherein said indicia added to said package in step (b) identifies said complexate as a regulatory approvable chemical entity. 
     
     
         22 . A method of adjusting the sales price of a packaged orally consumable film product, comprising the steps of:
 (a) selecting an orally consumable film product comprising a pharmaceutical active, said product having a manufacturing cost;   (b) selecting a complexing agent for use with the pharmaceutical active to form a complexate;   (c) estimating the cost of purchasing the complexing agent from a supplier;   (d) estimating the cost of manufacturing the complexate;   (e) determining the change in manufacturing cost of the orally consumable film product based on the additional cost estimates of steps (c) and (d); and   (f) adjusting the sales price of the product based on the change in manufacturing cost.   
     
     
         23 . The method of  claim 22 , further comprising the steps of:
 (g) determining whether additional safety and efficacy tests associated with the complexate are required; and   (h) estimating the cost associated with the additional safety and efficacy tests,   wherein step (e) further comprises determining the change in manufacturing cost of the orally consumable film product based on the additional cost estimate of step (h).   
     
     
         24 . The method of  claim 22 , further comprising the steps of:
 (i) determining whether a change in labeling on the product package is required to list the complexate as an active ingredient; and   (j) estimating the cost associated with the labeling change,   wherein step (e) further comprises determining the change in manufacturing cost of the orally consumable film product based on the additional cost estimate of step (j).   
     
     
         25 . The method of  claim 22 , further comprising the step of determining whether the adjusted sales price of step (f) is viable in the marketplace. 
     
     
         26 . A method of disseminating accurate drug information to consumers of a packaged pharmaceutical product, comprising the steps of:
 (a) providing a packaged pharmaceutical product comprising:
 (i) a complexate comprising a complexing agent and a pharmaceutical active; 
 (ii) an orally consumable film for delivery of said complexate; and 
 (iii) a package for containing said orally consumable film; 
   (b) providing indicia identifying the complexate as an active ingredient contained in the packaged pharmaceutical product; and   (c) exposing consumers to the indicia, thereby providing accurate information as to the active ingredient contained in the packaged pharmaceutical product.   
     
     
         27 . A method of marketing an orally consumable film product containing a complexate as the active ingredient to consumers, comprising the steps of:
 (a) identifying a first pharmaceutical product containing an active that has been marketed to consumers as an effective pharmaceutical product;   (b) providing a second pharmaceutical product comprising:
 (i) a complexate comprising a complexing agent and the active of step (a); and 
 (ii) an orally consumable film for delivery of the complexate; 
   (c) educating consumers that the complexate contained in the second pharmaceutical product provides the same effectiveness as the active contained in the first pharmaceutical product; and   (d) marketing the second pharmaceutical product to consumers.   
     
     
         28 . A method of developing a sales price for a packaged orally consumable film product including a complexate as the active ingredient, comprising the steps of:
 (a) selecting a pharmaceutical active and complexing agent to form the complexate included in the orally consumable film;   (b) estimating the cost of purchasing the complexing agent from a supplier;   (c) estimating the cost of purchasing the pharmaceutical active from a supplier;   (d) estimating the cost of manufacturing the complexate from the pharmaceutical active and the complexing agent;   (e) estimating the cost of producing and packaging the orally consumable film including the complexate;   (f) estimating the aggregate cost of safety and efficacy tests performed for the pharmaceutical active and the complexing agent individually;   (g) determining whether additional safety and efficacy tests for the complexate are required;   (h) estimating the cost associated with the additional safety and efficacy tests of step (g);   (i) adding the costs of the preceding steps to develop an estimated total manufacturing cost; and   (j) setting the sales price based on the estimated total manufacturing cost of the packaged orally consumable film product.   
     
     
         29 . A method of satisfying drug regulations promulgated by a regulatory body for an orally consumable film comprising a complexate as the active ingredient, said complexate comprising a complexing agent and a pharmaceutical active, comprising the steps of:
 (a) submitting safety and efficacy test results for the complexing agent and safety and efficacy test results for the pharmaceutical active to the regulatory body;   (b) determining whether additional safety and efficacy tests for the complexate are required by the regulatory body;   (c) conducting the safety and efficacy tests of step (b); and   (d) submitting the results of the safety and efficacy tests of step (c) to the regulatory body to satisfy the drug regulations of the regulatory body for the orally consumable film product.   
     
     
         30 . The method of  claim 29 , further comprising the step of determining whether a change in labeling on the package for the orally consumable film is required by the regulatory body to list the complexate as an active ingredient.