ANALYTICAL DEVICES FOR DETECTION OF LOW-QUALITY PHARMACEUTICALS

• US 20140051173A1
• Filed: 03/14/2013
• Published: 02/20/2014
• Est. Priority Date: 08/17/2012
• Status: Active Grant

• Current Assignee: St. Mary'S College
• Original Assignee: St. Mary'S College
• Inventors: Barstis, Toni L. O., Bevilacqua, Mary M.
• Granted Patent: US 9,557,274 B2
• Time in Patent Office: Days
• US Class Current: 436/43
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

A multilayer Paper Analytical Device (PAD) is provided for detection of at least two chemical components indicative of a low quality pharmaceutical or dietary supplement product. A method for detection of at least two chemical components indicative of a low quality pharmaceutical or dietary supplement product is also provided that employs a multilayer PAD. A kit is provided for detection of at least two chemical components indicative of a low quality pharmaceutical or dietary supplement product that includes a multilayer PAD and instructions for using the kit.

Claims

1. A multilayer Paper Analytical Device for detection of at least two chemical components indicative of a low quality pharmaceutical product or dietary supplement, comprising:

one or more assay regions in communication with a non-chemically interfering binder agent disposed adjacent at least one hydrophobic layer; and

one or more vessels each having a wall that houses one or more reagents in registry with at least one assay region for which testing for a chemical component is desired;

wherein rupture of a vessel wall establishes communication between a corresponding assay region and the one or more reagents released by the ruptured vessel wall.

2. The device of claim 1, wherein the at least one vessel is fabricated from a rupturable material.

3. The device of claim 1, wherein the one or more vessels are integral with at least assay region.

4. The device of claim 1, wherein the one or more vessels when ruptured are in fluid communication with the assay region.

5. The device of claim 1, wherein at least one or more of an information identification zone and a color calibration zone is provided on the Paper Analytic Device.

6. The device of claim 1, further comprising at least one electronically readable information zone that, after activation of the device, provides color information necessary for detection of the at least two chemical components, and wherein the least one electronically readable information zone comprises alignment references for transforming or correcting a captured image of the Paper Analytical Device to facilitate analysis and processing of the color information to more accurately detect the at least two chemical components.

7. The device of claim 6, wherein the alignment references include a plurality of fiducial markers for orienting the captured image.

8. The device of claim 6, wherein the hydrophilic substrate includes one or more user compliance or quality control regions.

9. The device of claim 6, wherein the chemical components to be detected include an active ingredient and an excipient, wherein the active ingredient includes at least one of a pharmaceutical or dietary supplement compound and wherein the color information determines whether an inappropriate combination of active ingredient and excipient is present, indicative of a low quality pharmaceutical or dietary supplement product.

10. A method for detection of at least two chemical components indicative of a low quality pharmaceutical or dietary supplement product, which comprises:

providing a multilayer analytical device according to claim 1;

disposing the pharmaceutical product to be analyzed into assay regions;

activating the device in a manner such that the reagents contact the product to be analyzed in the assay regions to provide color information; and

analyzing the color information to detect the presence or absence of the at least two chemical components.

11. The method of claim 10, wherein the pharmaceutical or dietary supplement product to be analyzed is disposed upon the assay regions by depositing the product onto the device or by applying a dilution containing the product onto the device;

wherein the activating of the device includes rupturing of the vessel wall sufficiently to enable release of the reagents therein to establish communication with the assay regions; and

wherein disposing the product into the assay region and activating the device cause a color change that can be analyzed to detect the presence or absence of the chemical components in the product.

12. The method of claim 10, wherein the device further includes a color calibration zone and the method further comprises automating the color analyzing by:

capturing an image of the device using a camera device; and

providing image analysis software capable of recognizing and quantifying a color change within the assay regions of the device that is shown in the captured image.

13. The method of claim 12, which further comprises:

repeating the detection for a plurality of pharmaceutical and dietary supplement products; and

compiling a database of the captured images of the analytical devices, including time stamping and geo-tagging of the captured images.

14. The method of claim 10, wherein the chemical components to be detected include an active ingredient and an excipient, and:

the presence of one of the chemical components determines that the pharmaceutical or dietary supplement product contains an insufficient amount of active ingredient;

the absence of one of the chemical components determines that the product does not contain an appropriate active ingredient;

the absence of one of the chemical components determines that the product does not contain an appropriate excipient;

or

the presence of one of the chemical components determines that the product contains an inappropriate excipient.

15. The method of claim 10, wherein the chemical components to be detected include an active ingredient and an excipient, wherein the active ingredient includes at least one of an anti-malarial, antibiotic, anti-parasitic, cox-inhibitor, analgesic, antipyretic, anti-viral, anti-cancer and dietary supplement compound and wherein the color information determines whether an inappropriate combination of active ingredient and excipient is present, indicative of a low quality pharmaceutical or dietary supplement product.

16. A kit for detection of at least two chemical components indicative of a low quality pharmaceutical or dietary supplement product, the kit comprising:

a multilayer analytical device according to claim 1;

instructions for using the kit; and

a solvent that is present in an amount sufficient to dilute the product to be analyzed to an analyzable concentration.