Pharmaceutical dosage forms fabricated with nanomaterials for quality monitoring

• US 20090004231A1
• Filed: 06/25/2008
• Published: 01/01/2009
• Est. Priority Date: 06/30/2007
• Status: Abandoned Application

• Current Assignee: SMP Logic Systems LLC
• Original Assignee: SMP Logic Systems LLC
• Inventors: Popp, Shane M.
• Application Number:
  US12/215,720
• Publication Number:
  US 20090004231A1
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 39/00 Medicinal preparations containing antigens or antibodies materials for immunoassay G01N33/53
• CPC Class Codes: A61K 9/1075 Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers A61K9/0026 takes precedence
• CPC Class Codes: A61K 9/5107 Excipients; Inactive ingredients
• CPC Class Codes: A61K 9/5192 Processes
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: G01N 21/80 Indicating pH value
• CPC Class Codes: G01N 21/9508 Capsules; Tablets

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.

Claims

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.