Pharmaceutical dosage forms fabricated with nanomaterials for quality monitoring

Abstract

Nanomaterials fabricated to pharmaceutical dosage forms used to monitor quality of the drug product enclosed therein are disclosed. The nanomaterials are useful to provide a plurality of quality analysis to the dosage form. Consequently, the nanomaterials provide a means to perform quality testing on a continuous basis throughout the supply chain, including the cold chain whereby manufacturers and distributors can achieve greater product integrity and longer shelf life and ultimately minimize cost. The end user benefits in obtaining the highest quality drugs at the time of need.

1 ) A method of fabricating a nanomaterial into a pharmaceutical dosage form said method comprising,
 a) contacting a nanomaterial to a pharmaceutical dosage form;   b) interfacing the nanomaterial with a drug product enclosed within the pharmaceutical dosage form.   c) enclosing the drug product into the pharmaceutical dosage form whereby the nanomaterial monitors the drug product properties.   
     
     
         2 ) The method  claim 1 , wherein the nanomaterial is selected from the group consisting of a nanopowder, nanowire, nanofiller, nanocrystal, and nanocomposite. 
     
     
         3 ) The method of  claim 1 , wherein the pharmaceutical dosage form is set forth in Table I. 
     
     
         4 ) The method of  claim 1 , wherein the drug product properties are selected from the group consisting of pH, temperature, oxidation, degradation, potency, and leachates. 
     
     
         5 ) A kit comprising the pharmaceutical dosage form of  claim 1 . 
     
     
         6 ) A method of monitoring quality of a drug product enclosed within a pharmaceutical dosage form said method comprising,
 a) Enclosing a drug product in a pharmaceutical dosage form fabricated with a nanomaterial;   b) monitoring properties of the drug product enclosed therein with the nanomaterial;   c) analyzing a quality schema to make a risk based assessment;   
     
     
         7 ) The method of  claim 6 , wherein the monitoring occurs from the point of packaging until the drug product reaches the end user. 
     
     
         8 ) The method of  claim 6 , wherein the properties are selected from the group consisting of pH, temperature, phase transition, degradation, potency, and solubility. 
     
     
         9 ) The method of  claim 6 , wherein the quality schema is selected from the group consisting of color change, symbol display, and word display. 
     
     
         10 ) The method of  claim 6 , wherein the nanomaterial is optically enhanced. 
     
     
         11 ) The method of  claim 6 , wherein the nanomaterial is thermally enhanced. 
     
     
         12 ) The method of  claim 6 , wherein the monitoring occurs in a cold chain. 
     
     
         13 ) A kit comprising a pharmaceutical dosage form which performs the method of  claim 6 . 
     
     
         14 ) A pharmaceutical dosage form by a process comprising,
 a) fabricating a pharmaceutical dosage form with a functional nanomaterial;   b) operably interfacing the functional nanomaterial with a drug product enclosed within the dosage form;   c) enclosing the drug product into the pharmaceutical dosage form wherein the pharmaceutical dosage form monitors the quality of the drug product.   
     
     
         15 ) The dosage form of  claim 14 , wherein said dosage form is selected from Table I.