Analytical devices for detection of low-quality pharmaceuticals

• US 10,119,981 B2
• Filed: 09/01/2016
• Issued: 11/06/2018
• 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.
• Primary Examiner(s): Siefke, Samuel P
• Application Number:
  US15/254,186
• Publication Number:
  US 20160370389A1
• Time in Patent Office: 796 Days
• 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: G01N 33/15 Medicinal preparations ; Physical properties thereof, e.g. dissolubility
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G01N 33/9446 Antibacterials
• CPC Class Codes: Y10T 436/11 Automated chemical analysis

Abstract

A multilayer Paper Analytical Device (PAD) and method for detection of a low quality pharmaceutical or dietary supplement product. The multilayer PAD includes one or more assay regions, one or more reagent vessels in registry with the assay region(s), and a non-chemically interfering binder agent disposed between the assay regions and vessels, so that rupture of the vessels enables the reagents to wet the assaying regions and contact a sample of a suspected low quality pharmaceutical product or dietary supplement for testing thereof. A kit is also provided for detection of a low quality pharmaceutical or dietary supplement product, the kit including a multilayer PAD and instructions for using the kit.

Claims

1. A multilayer paper analytical device for detection of a low quality pharmaceutical product or dietary supplement, comprising:

one or more assay regions;

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; and

a non-chemically interfering binder agent disposed between the assay regions and vessels;

wherein the vessels are arranged to be adjacent to the assaying regions with the binding agent providing a fluid path such that rupture of a vessel wall establishes fluid communication between the one or more reagents released by the ruptured vessel wall and the corresponding assay region along the fluid path;

a hydrophobic material in the form of a sheet that is adjacent each vessel and that has openings that forms part of the fluid path for each vessel;

wherein each assay region is configured to receive a sample of a suspected a low quality pharmaceutical product or dietary supplement such that, after activation of the device by rupturing of a vessel wall in registry with the assay region, the reagent wets the assaying region for reaction with the sample.

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 binder agent is parafilm, the assaying region comprises a hydrophilic substrate, the assaying region is adhered to the plastic sheet of the hydrophobic material by the parafilm, and the parafilm has an opening which is in alignment with the opening of the hydrophobic material sheet to assist in forming the fluid path between the vessel and the assaying region.

4. The device of claim 1, wherein the hydrophobic material is part of a lamination that surrounds the one or more vessels to contain therein any fluid which does not flow to the assaying region and the assaying regions are attached to an outer surface of the plastic sheet.

5. The device of claim 1, further comprising an informational substrate that is associated with the PAD in a visible position thereon.

6. The device of claim 5, wherein the informational substrate includes an information identification zone or a color calibration zone that includes reference colors to assist in processing of the color information obtained from the assay regions after activation of the device to more accurately detect the at least two chemical components, or both zones.

7. The device of claim 5, wherein the informational substrate includes at least one optically 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 optically 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.

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

9. The device of claim 1, further comprising at least one or both of an identification tag and a timer region that indicates when the test is completed.

10. The device of claim 5, wherein the informational substrate is included in the lamination and isolated from the vessels.

11. The device of claim 1, which includes one or more additional assaying regions that contain dry reagents that are activated by the separate addition of a solvent to conduct further testing of a sample of the product.

12. A method for detection 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 certain chemical components of the pharmaceutical or dietary supplement product.

13. The method of claim 12, 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 of the product.

14. The method of claim 12, wherein the device further includes a color calibration zone that includes reference colors to assist in processing of the color information obtained from the assay regions after activation of the device to more accurately detect the at least two chemical components, 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.

15. 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.

16. The method of claim 12, 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.

17. The method of claim 12, 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.

18. The method of claim 12, 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.

19. A kit for detection 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.