SYSTEM AND METHOD FOR AUTHENTICATING TABLETS

• US 20090075261A1
• Filed: 12/11/2007
• Published: 03/19/2009
• Est. Priority Date: 04/16/2003
• Status: Active Grant

• Current Assignee: APDN (B.V.I.) Inc. (Applied DNA Sciences Incorporated)
• Original Assignee: APDN (B.V.I.) Inc. (Applied DNA Sciences Incorporated)
• Inventors: HAYWARD, JAMES A., LIANG, MING-HWA, SHU-KIN-SO, STEPHANE
• Granted Patent: US 8,420,400 B2
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: C08K 5/09 Carboxylic acids; Metal salts thereof; Anhydrides thereof
• CPC Class Codes: C09D 11/03 characterised by features other than the chemical nature of the binder
• CPC Class Codes: C12Q 1/6816 characterised by the detection means C12Q1/6804 takes precedence
• CPC Class Codes: C12Q 2563/185 Nucleic acid dedicated to use as a hidden marker/bar code, e.g. inclusion of nucleic acids to mark art objects or animals
• CPC Class Codes: Y10T 436/14 Heterocyclic carbon compound [i.e. , O, S, N, Se, Te, as only ring hetero atom]
• CPC Class Codes: Y10T 436/143333 Saccharide [e.g., DNA, etc.]
• CPC Class Codes: Y10T 442/2508 Coating or impregnation absorbs chemical material other than water

Abstract

A method for authenticating and verifying a pharmaceutical item to be genuine is described. The method for authenticating a tablet comprises applying a particular nucleic acid material associated with a particular sequence of nucleic acid bases to a tablet or capsule. The method also comprises collecting a sample of the tablet and verifying the tablet is genuine by detecting the particular nucleic acid material.

Claims

1. A tablet authentication method comprising:

applying a particular nucleic acid material to the tablet, said nucleic acid material associated with a particular sequence of nucleic acid bases;

detecting the particular nucleic acid material in the tablet,

collecting a sample of the nucleic acid material, and

verifying said tablet is genuine by detecting said particular nucleic acid material in said tablet.

2. The method of claim 1, wherein said verifying comprises, performing polymerase chain reaction (PCR) technique.

3. The method of claim 1 wherein applying said tablet with a particular nucleic acid material associated with a particular sequence of nucleic acid bases comprises performing the marking throughout the entire surface of the tablet.

4. The method of claim 1, wherein applying said tablet with a particular nucleic acid material associated with a particular sequence of nucleic acid bases comprises performing the marking in a specific area on the surface of the tablet.

5. The method of claim 4, wherein said marking comprises a form of human recognizable symbolic icon.

6. The method of claim 4, wherein said marking comprises a form of machine readable code providing for tablet identification.

7. The method of claim 1, further comprising applying a particular nucleic acid material associated with a particular sequence of nucleic acid bases on a package associated with said tablet to verify authenticity of the source and distributor of the tablet prior to consumption of the tablet by a user.

8. The method of claim 1, wherein the tablet is selected from a group consisting of a caplet, a gel-cap, a pellet, a gum-piece, a capsule, an edible item that is biocompatible that contains any consumable herb, chemical, mineral, vitamin, plant or animal product, or placebo.

9. The method of claim 1, wherein the particular nucleic acid material is deoxyribonucleic acid (DNA).

10. The method of claim 1, wherein the particular nucleic acid material is ribonucleic acid (RNA).

11. The method for authenticating a tablet comprising the steps of;

providing an optical reporter marker, the optical reporter marker having at least one light emitting upconverting phosphor particle linked to at least one nucleic acid material, the nucleic acid material having an identifiable portion,

introducing the optical reporter marker to the tablet of interest,

detecting the optical reporter marker associated with the tablet with a light source,

obtaining a sample of the optical reporter marker from the tablet of interest for analysis; and

analyzing the collected sample to detect the presence of the identifiable portion of the nucleic acid material linked to the upconverting phosphor particle.

12. The method of claim 11, wherein the optical reporter marker has the composition of the formula I:

(cOpR)-[L-(NA)]_m 

 

I

wherein;

m is an integer greater than 1;

(cOpR) is a coated optical reporter particle;

(NA) is a nucleic acid oligomer of the nucleic acid material of detectable sequence; and

L is a linking group covalently bound to the coated optical reporter particle and to the nucleic acid oligomer.

13. The method of claim 12, wherein (cOpR) comprises an upconverting phosphor (UCP) material.

14. The method of claim 12, wherein (NA) is a single or double stranded DNA molecule having a length of between about 40 base pairs and about 1000 base pairs.

15. The method of claim 12, wherein L comprises an alkylene moiety having a first end covalently bound to the coated optical reporter particle and a second end covalently bound to the nucleic acid oligomer.

16. The method of claim 13, wherein (UCP) is an upconverting phosphor particle of the formula:

Y_xYb_yEr_zO₂S;

or

Na(Y_xYb_yEr_z)F₄;

wherein;

x is from about 0.6 to about 0.95;

y is from about 0.05 to about 0.35; and

z is from about 0.1 to about 0.001.

17. The method of claim 12, wherein L is of the formula:

-A-R¹—

B—

wherein;

R¹ is C_2-8alkylene;

-A- is a group covalently bonded to the surface of the coated optical reporter; and

—

B—

is a group covalently bonded to the 3′

or 5′

end of the nucleic acid oligomer.

35. The composition of claim 33, wherein the composition is of the formula V:

(UCP)-[O—

(CH₂)_s—

NH—

C(O)—

(CH₂)_u—

C(O)—

NH—

(CH₂)_v-(DNA)]_m 

 

V

wherein;

s is from 2 to 6;

v is from 2 to 6;

u is 2 or 3; and

m, UCP and DNA are as recited in claim 15.

18. A method for authenticating tablet or tablet packaging comprises the steps of;

providing an optical reporter marker, the optical reporter marker having at least one light emitting upconverting phosphor particle linked to at least one nucleic acid taggant, the nucleic acid taggant having an identifiable portion,

introducing the optical reporter marker to the article of interest,

detecting the optical reporter marker associated with the article of interest with a light source,

obtaining a sample of the optical reporter marker from the article of interest for analysis; and

analyzing the collected sample to detect the presence of the identifiable portion of the nucleic acid taggant linked to the upconverting phosphor particle.

19. The method of claim 18, wherein the optical reporter marker has the composition of the formula I:

(cOpR)-[L-(NA)]_m 

 

I

wherein;

m is an integer greater than 1;

(cOpR) is a coated optical reporter particle;

(NA) is a nucleic acid oligomer of detectable sequence; and

L is a linking group covalently bound to the coated optical reporter particle and to the nucleic acid oligomer.

20. The method of claim 19, wherein (cOpR) comprises an upconverting phosphor (UCP) material.

21. The method of claim 19, wherein (NA) is a single or double stranded DNA molecule having a length of between about 40 base pairs and about 1000 base pairs.

22. The method of claim 19, wherein L comprises an alkylene moiety having a first end covalently bound to the coated optical reporter particle and a second end covalently bound to the nucleic acid oligomer.

23. The method of claim 20, wherein (UCP) is an upconverting phosphor particle of the formula:

Y_xYb_yEr_zO₂S;

or

Na(Y_xYb_yEr_z)F₄;

wherein;

x is from about 0.6 to about 0.95;

y is from about 0.05 to about 0.35; and

z is from about 0.1 to about 0.001.

24. The method of claim 19, wherein L is of the formula:

-A-R¹—

B—

wherein;

R¹ is C_2-8alkylene;

-A- is a group covalently bonded to the surface of the coated optical reporter; and

—

B—

is a group covalently bonded to the 3′

or 5′

end of the nucleic acid oligomer.

25. The method of claim 24, wherein -A- is —

O—

.

26. The method of claim 24, wherein —

R¹—

is —

(CH₂)_n— and

wherein n is from 2 to 8.

27. The method of claim 24, wherein —

B—

is;

—

S—

;

—

O—

;

—

NR^a—

;

—

S—

(CH₂)_p—

;

—

O—

(CH₂)_p—

;

—

NR^a—

(CH₂)_p—

;

—

S—

(CH₂)_q—

C(O)—

NR^a—

(CH₂)_p—

,

—

O—

(CH₂)_q—

C(O)—

NR^a—

(CH₂)_p—

;

—

NR^a—

(CH₂)_q—

C(O)—

NR^a—

(CH₂)_p—

;

—

S—

C(O)—

(CH₂)_r—

C(O)—

NR^a—

(CH₂)_p—

;

—

O—

C(O)—

(CH₂)_r—

C(O)—

NR^a—

(CH₂)_p—

;

or

—

NR^a—

C(O)—

(CH₂)_r—

C(O)—

NR^a—

(CH₂)_p—

;

wherein;

p is from 2 to 8;

q is from 1 to 8;

r is from 2 to 8; and

each R^a is independently hydrogen or C_1-6alkyl;

28. The method of claim 24, wherein —

B—

is;

—

S—

(CH₂)_q—

C(O)—

NR^a—

(CH₂)_p or

—

NR^a—

C(O)—

(CH₂)_r—

C(O)—

NR(CH₂)_p—

;

wherein p, q, r and R^a are as recited in claim 9.

29. The method of claim 28, wherein:

p is from 2 to 6;

q is from 1 to 3; and

r is 2 or 3.

30. The method of claim 24, wherein —

B—

is;

—

S—

CH₂—

C(O)—

NH—

(CH₂)₆—

;

or

—

NH—

C(O)—

(CH₂)₃—

C(O)—

NH—

(CH₂)₆—

;

31. The method of claim 19, wherein the cOpR is coated with silica.

32. The method of claim 31, wherein the silica comprises at least one Si—

O bond.

33. The method of claim 18, wherein the optical reporter marker has the composition of the formula II:

(UCP)-[A-R¹—

X—

R²—

C(O)—

NR^a—

R³-(DNA)]_m 

 

II

wherein;

m is an integer greater than 1;

UCP is an upconverting phosphor particle;

DNA is a single or double stranded deoxyribonucleic acid oligomer;

-A- is a group capable of covalently bonding to the surface of the Upconverting phosphor particle;

R¹ is C_2-8alkylene,

R² is C_1-8alkylene or —

C(O)—

C_1-8alkylene-;

—

X—

is —

O—

, —

S—

or —

NR^a—

;

R³ is C_2-8alkylene; and

R^a is hydrogen or C_1-6alkyl.

34. The composition of claim 33, wherein the composition is of the formula IV:

(UCP)-[O—

(CH₂)_s—

S—

(CH₂)_t—

C(O)—

NH—

(CH₂)_v-(DNA)]_m 

 

IV

wherein;

s is from 2 to 6;

v is from 2 to 6;

t is from 1 to 3; and

m, UCP and DNA are as recited in claim 32.

36. The composition of claim 33, wherein the composition is of the formula VI:

(UCP)-[O—

(CH₂)₃—

S—

CH₂—

C(O)—

NH—

(CH₂)₆-(DNA)]_m 

 

VI

wherein m, UCP and DNA are as recited in claim 32.

37. The composition of claim 33, wherein the composition is of the formula VII:

(UCP)-[O—

(CH₂)₃—

NH—

C(O)—

(CH₂)₃—

C(O)—

NH—

(CH₂)₆-(DNA)]_m 

 

VII

wherein m, UCP and DNA are as recited in claim 32.

38. The composition of claim 19, wherein the cOpR comprises a visually detectable light emitting material selected from the group consisting of a fluorescent dye, a upconverting phosphor, a ceramic powder, or a quantum dot.

39. The composition of claim 38, where said light emitting materials are excitable by UV or an infrared light source.

40. The method of claim 19, wherein the cOpR comprises at least one electromagnetic emitting material.

41. The composition of claim 40, where the electromagnetic emitting material is detectable by devices which provide sources selected from the group consisting of an infrared radiation source, magnetic field source, a quantum dot or electromagnetic pulse.

42. The method of claim 18, wherein detecting the nucleic acid taggant comprises polymerase chain reaction analysis.

43. The method of claim 18, wherein the nucleic acid taggant is ds DNA.

44. The method of claim 18, wherein the article is selected from the group of a manufactured good, a painting and frame, monetary paper, ink, fabric, a metal machined part, CD-ROM, a tablet, or an electronic part.

45. The method of claim 18, wherein said associating the optical reporter marker with the article of interest further comprises a database management system that associates the specific optical reporter marker with said article of interest.

46. A method for authenticating a particular good, comprising:

providing a optical reporter marker having at least one nucleic acid taggant;

applying the marker compound to at least one particular good, which enters at least one supply chain;

locating and collecting a sample of the optical reporter marker from said particular good after said particular good has entered said supply chain; and

identifying said nucleic acid product in said particular good.

47. A kit for authenticating articles comprising:

a container of optical reporter marker; and

an applicator for applying a sample of the optical reporter to the article.