CA2858923C

CA2858923C - Uniquely identifiable drug dosage form units

Info

Publication number: CA2858923C
Application number: CA2858923A
Authority: CA
Inventors: David Prokop
Original assignee: Individual
Current assignee: Individual
Priority date: 2014-08-08
Filing date: 2014-08-08
Publication date: 2018-12-18
Anticipated expiration: 2034-08-08
Also published as: CA2858923A1; CA3023359A1; CA3023359C

Abstract

The present invention provides products, systems, and methods for the unique identification of individual drug dosage form units. The invention includes: random integrated optical identification marking of an individual drug unit; a lack of direct surface-to-surface contact between a marking instrument and the drug unit, i.e., deposition of a mark; drug unit image data based on the identification mark; a secondary product identifier associated with the individual drug unit; and comparing the marked drug unit to drug unit image data.

Description

2 Uniquely Identifiable Drug Dosage Form Units

3

4 7 In the United States, commercially available individual solid oral drug dosage form units 8 ("drug units") are not conventionally separable and uniquely identifiable on a per unit basis.
9 Instead, each individual drug unit is identified based on its conformity to a uniform standard established for each drug product, such that drug units for a given drug product are typically 11 indistinguishable from each other.
12 Current drug product identification is, in part, governed by Title 21 of the Code of 13 Federal Regulations, Section 206.10, which provides a mechanism for the routine identification 14 of solid oral dosage form drug products. That is, no drug product in a solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless each of its drug 16 units is clearly marked or imprinted with a "code imprint" that, in conjunction with the unit's 17 size, shape, and color, permits the identification of the drug product and the manufacturer or 18 distributor of the drug product. A code imprint can refer to any single letter or number or any 19 combination of letters and numbers, including, e.g., words, company name, and National Drug Code, or a mark, symbol, logo, or monogram, or a combination of letters, numbers, and marks or 21 symbols, assigned by a drug firm to a specific drug product. Such code imprints are usually 22 uniformly coarsely embossed, debossed, engraved, stamped, or printed with ink onto or into each 23 unit of a particular drug product as part of, or after, the manufacturing process.
24 While standardizing drug product appearance and requiring that each unit of a particular drug product conforms to the same criteria assists identification of drug units by comparison to a 26 pre-set type for drug products generally, such uniformity also facilitates drug counterfeiting and 27 obstructs the tracking and authentication of individual drug units. Once a counterfeiter is able to 28 passably replicate the appearance of a single drug unit, production of mass quantities of drug 29 units of a particular counterfeit drug product can proceed relatively unhindered. Counterfeiting is also aided, for example, by the ready commercial availability of tablet and pill manufacturing 31 equipment, well-known and openly published fabrication methods, and fabrication methods and 32 parameters that may be easily derived from direct observation of the code imprint and drug unit.

1 Efforts to create separable and uniquely identifiable drug units and drug unit 2 authentication systems have been made. For example, the use of bar codes, engravings, stamps, 3 etc. has been proposed as a way to uniquely identify individual drug units. However, such 4 proposals require surface-to-surface contact between a marking instrument and each drug unit to identify each unit. Such direct surface-to-surface contact is undesirable for several reasons 6 including, but not limited to, insertion of additional, expensive, slowing, and/or complicating 7 steps into the process of manufacture, possible interference with other uniform drug product 8 features useful for general product identification, and/or compromising the surface integrity 9 and/or stability of the drug unit. Further, such efforts typically require that the end user have some sort of non-human machine visual or optical scanning device or reader to ascertain the 11 meaning of, and to track and authenticate, each marked drug unit. The need for and reliance on 12 such non-human analytical tools elevates the cost associated with using such marks and restricts 13 patients and/or other end users' access and ability to independently authenticate marks.

In its broadest sense, the present invention includes products, systems, and methods 16 comprising: a random integrated optical identification mark on an individual product unit;
17 product image data based on the identification mark; a secondary product identifier; and product 18 unit authentication or tracking based on comparison of the identification mark to product image 19 data.
In one embodiment, the present invention includes products, systems, and methods 21 comprising: a random integrated optical identification mark on an individual product unit;
22 product image data based on the identification mark; a secondary product identifier associated 23 with the individual product unit; product unit authentication based on comparison of the 24 identification mark to product image data; and providing electronic, computer, mobile, wireless, and/or web-based technology to facilitate comparison of an identification mark on an individual 26 product unit with the product image data.
27 In another embodiment, the present invention includes products, systems, and methods 28 comprising: a random integrated optical identification mark on an individual product unit, 29 wherein the random integrated optical identification mark is made without direct surface-to-surface contact between a marking instrument and the product unit (herein the term "deposited"
31 is used to describe an identification mark made without direct surface-to-surface contact between 32 a marking instrument and the product unit); product image data based on the identification mark;
33 a secondary product identifier associated with the individual product unit; product unit 1 authentication based on comparison of the identification mark to product image data; and 2 providing electronic, computer, mobile, wireless and/or web-based technology to facilitate 3 comparison of a marked product unit with the product image data.
4 The present invention has wide applicability to the consumer products and the regulated products market because it provides for the first time elegant products, systems, and methods by 6 which individual product units can be marked and authenticated. For example, the principles of 7 the present invention and variations thereof may be applied to various products including, but not 8 limited to, electronics hardware, fashion, publishing, medical devices and disposables (such as 9 vials or syringes), medical records, educational and professional credentials, banknotes, contracts, professional service products, etc.
11 For our present purposes, however, this application specifically focuses on a preferred 12 embodiment of the present invention for use with creating a secure drug product system 13 involving the random marking of drug product units to facilitate authentication. Accordingly, 14 the present invention can be used to protect public health and industry by providing an elegant solution to widespread drug counterfeiting, derivation, and authentication problems.
16 Conventional technologies related to drug product manufacture, optical and pattern 17 recognition, and electronic, computer, mobile, wireless, and/or web-based technology may be 18 used together with the present invention; nonetheless, it is also contemplated that further 19 developments in each of these technology areas may be forthcoming that may also be used together with the present invention. Further, the present invention, as a whole, substantially 21 builds on and significantly departs from each these widely divergent technological fields.
22 Accordingly, the present invention gives rise to wholly new and fundamentally distinct products, 23 systems, and methods and significant and unexpectedly superior results leading to easier, 24 cheaper, faster, better, safer, more certain, and more user-friendly unit-level product authentication.
26 Contrary to conventional drug product identification regimes for individual solid oral 27 drug units which involve the identification of drug units based on conformity to a general pre-set 28 type, the present invention involves random integrated, i.e., non-separable, marking of drug units 29 to track and authenticate individual drug units.
One of many advantages arising from the present invention is that it can be 31 synergistically used with existing and/or forthcoming drug product identification systems and 32 regimes. That is, the present invention may be synergistically used with other secure labeling 33 practices (e.g., QR codes, bar codes, RFID systems, etc.) already used, or to be developed for use 1 with, drug product packaging to track and authenticate individual drug units. A further 2 advantage is that the present invention may be implemented on a per unit basis together with 3 current "code imprint" requirements such that it need not interfere with other uniform drug 4 product features. Such other secure labeling practices and/or drug product "code imprint"
requirements may comprise one or more "secondary product identifiers" in accordance with the 6 present invention.
7 Another principle advantage of the present invention is that marking is deposited, such 8 that it does not require surface-to-surface contact between a marking instrument and each solid 9 oral drug unit in order to uniquely mark each unit. This feature of the present invention fundamentally distinguishes the present invention over the use of bar codes, engravings, stamps, 11 etc. Not only are marking products, systems, and methods that involve surface-to-surface 12 contact more complicated, more time-consuming, and likely more expensive to implement, but 13 such an approach also risks compromising the integrity and/or stability of the drug unit due to the 14 increased pressure, temperature differentials, and extra handling involved with the direct marking contact required to uniquely identify each drug unit.
16 Another principle advantage of the present invention is that it is highly adaptable to 17 accommodate a wide range of varying levels of tracking and authentication security. For 18 example, the present invention may only require that a user visually compare a randomly marked 19 drug unit with drug unit image data (e.g., one or more secured captured images) in order to authenticate the drug unit. Thus, the present invention delivers a means of drug authentication 21 directly to the drug unit consumer that does not require that the consumer either have or know 22 how to use fancy, expensive, and/or complicated image data tools.
Accordingly, this invention 23 empowers individual patients by giving them a greater measure of control over their own health 24 care, since the present invention allows the patient to "trust their own eyes" using their own independent visual authentication. Alternatively, the present invention also permits an extremely 26 high level of authentication security that can involve the use of secondary product identifiers, 27 varying levels of image analysis, biometric data, etc.

29 Figures 1A, B, C, and D depict prior art marked drug units suitable for use with the present invention.
31 Figures 2A and B depict marked drug units including exemplary data indicators used in 32 the analysis of marking information.

1 Figure 3 depicts a packaging line station for drug units according to the present 2 invention.
3 Figure 4 depicts variations of drug unit markings that may be used in accordance with 4 the present invention.
Figure 5 provides a flow chart for an exemplary low security marked drug unit 6 authentication process.
7 Figure 6 provides a flow chart for an exemplary production process involving the 8 integrated marking of drug units.

This invention comprises: random integrated optical identification marking of an 11 individual drug unit; a lack of direct surface-to-surface contact between a marking instrument 12 and the drug unit, i.e., deposition of a mark; drug unit image data based on the identification 13 mark; a secondary product identifier associated with the individual drug unit; and comparing the 14 marked drug unit to drug unit image data.
As used herein, the term "drug unit" refers to any solid and/or semi-solid drug dosage 16 unit for external or internal use in a human or animal subject, including, but not limited to, pills, 17 tablets, capsules, lozenges, wafers, patches, therapeutic bandages, suppositories, and/or other 18 solid or semi-solid absorbables placed outside of or within a body. Drug units are in no way 19 limited to solid oral drug dosage forms.
As used herein, the terms "mark," "marked," and "marking" refer to the random optical 21 modification on the surface of and/or within each drug unit itself using one or more of dots, 22 spots, shapes, splashes, sprays, splatters, speckles, threads, granules, or the like. Optionally, 23 marking may comprise multiple tiers and, for example, additionally include one or more 24 additional nano-blocks, nano-cubes, nano-particles, or nano-dice embedded in the drug unit.
As used herein, the term "secondary product identifier" refers to any additional drug 26 product identification, such as QR codes, bar codes, RFID systems, etc., located on the drug 27 product packaging (including boxes, bottles, lids, blister packs, labels, tags, information sheets, 28 pamphlets, etc.), any associated information such as a receipt or a prescription, any uniform drug 29 product characteristics, and/or any such removable component associated with the drug unit, etc.
As used herein, the term "interne website" refers to any electronically-aided 31 communication, and may or may not involve the internet and may or may not operate in a public 32 or private sphere.

1 1. Drug Unit Marking 2 Drug unit-level marking is based on random optical modification on the surface of and/or 3 within each drug unit itself using one or more of dots, spots, shapes, splashes, splatters, speckles, 4 threads, granules, or the like, to mark each drug unit. The random unit-level marking is done by deposition, i.e., without requiring any direct surface-to-surface contact between a marking device 6 and the drug unit surface. Random marking of each drug unit itself can be accomplished by: (1) 7 dotting, spotting, splashing, spraying, splattering, speckling, adding threads, and/or adding 8 granule marking materials to the surface of the drug unit; and/or (2) mixing or otherwise 9 integrating marking components (e.g., colored granules or other components) into a base formulation of the drug unit. The marking of each drug unit may involve one or more of various 11 colors and/or materials. Optionally, marking may comprise multiple tiers involving both surface 12 markings and one or more marking components integrated within the base formulation of the 13 drug unit, such as threads, granules, nano-blocks, nano-cubes, nano-particles, nano-dice, etc.
14 Importantly, the marking of each drug unit is integral and inseparable from each drug unit itself. Accordingly, the marking cannot be removed from the drug unit without detectable 16 destruction of the drug unit itself.
17 In a preferred embodiment, the marking materials can be used in a manner 18 complementary to, and not impeding, drug product "code imprints" or other general 19 characteristics used to identify particular drug products.
The visual or optical marking modification of the drug unit surface optionally allows for 21 varying levels of penetration of one or more marking materials into the drug unit surface.
22 Marked drug units may optionally include a protective, sealing, and/or otherwise image-23 enhancing top or outer coating.
24 The one or more marking materials can be applied to an entire external surface of a drug unit. Alternatively, the one or more marking materials can be applied to a particular surface or 26 surfaces, location, segment, region, or limited area of the drug unit.
The marking materials can 27 be applied in a particular sequential order, series, and combination, or simultaneously. The 28 marking materials may or may not generally conform to a general design or pattern, a set 29 tolerance allowance for unit-to-unit variability, etc. The marking materials may be visible or invisible to the naked human eye, and/or visible or invisible with the aid of technology-enhanced 31 vision, machine-aided, and/or computer-aided vision. The marking materials may alter the 32 surface texture and/or tactile feel of the drug unit.

1 In one embodiment, materials and methods used for the random marking of drug units 2 may, optionally, vary for each production lot, batch, production date, or any other such 3 production groups. This production group level of variation can both 1) further aid drug unit-4 level tracking and authentication by further increasing the ability to provide unique and readily identifiable markings tied to other production information, and 2) decrease the likelihood of 6 effective counterfeiting efforts by continued alteration of random marking production 7 parameters.
8 Conventional methods and materials, including regulation approved (e.g., U.S. Food and 9 Drug Administration ("FDA")) materials, can be used to accomplish the random marking of drug units. Accordingly, marking materials may comprise one or more inks, dyes, and/or color 11 additives, including but not limited to, alumina (dried aluminum hydroxide), annatto extract, 12 calcium carbonate, canthaxanthin, caramel, 13-carotene, cochineal extract, carmine, potassium 13 sodium copper chlorophyllin (chlorophyllin-copper complex), dihydroxyacetone, bismuth 14 oxychloride, synthetic iron oxide, ferric ammonium ferrocyanide, ferric ferrocyanide, chromium hydroxide green, chromium oxide greens, guanine, mica-based pearlescent pigments, 16 pyrophyllite, mica, talc, titanium dioxide, aluminum powder, bronze powder, copper powder, 17 zinc oxide, FD&C Blue No. 1, FD&C Blue No. 2, D&C Blue No. 4, FD&C Green No. 3, D&C
18 Green No. 5, D&C Green No. 6, D&C Green No. 8, D&C Orange No. 4, D&C
Orange No. 5, 19 D&C Orange No. 10, D&C Orange No. 11, FD&C Red No. 3, FD&C Red No. 4, D&C Red No.
6, D&C Red No. 7, D&C Red No. 17, D&C Red No. 21, D&C Red No. 22, D&C Red No.
27, 21 D&C Red No. 28, D&C Red No. 30, D&C Red No. 31, D&C Red No. 33, D&C Red No. 34, 22 D&C Red No. 36, D&C Red No. 39, FD&C Red No. 40, D&C Violet No. 2, FD&C
Yellow No.
23 5, FD&C Yellow No. 6, D&C Yellow No. 7, Ext. D&C Yellow No. 7, D&C
Yellow No. 8, D&C
24 Yellow No. 10, D&C Yellow No. 11, and/or other FDA approved color additives.
2. Drug Unit Image Data 26 The present invention additionally involves capturing at least one image corresponding to 27 each randomly marked drug unit. Multiple images of each drug unit may also be taken from one 28 or more perspectives. Multiple images of each drug unit may also be taken under one or more 29 different environmental, lighting, and speed conditions. Multiple images of each drug unit may also be taken at one or more discreet times.
31 Images of drug units may be taken separately for each individual drug unit. Images may 32 also be taken of multiple drug units together. Images of drug units may be taken prior to, during, 33 or after packaging. For example, one or more images may be taken of multiple drug units 1 comprising parts of the same production run. Also, one or more images may be taken of 2 multiple drug units packaged together in a transparent blister pack. In another example, one or 3 more images of the contents of a particular pill bottle, including each of the individual drug units, 4 may be taken.
Information, including secondary identifier information, can be associated with each 6 captured image and/or drug unit image data. Additional information, such as the production 7 details associated with the batch and lot number, production date, production location, source, 8 type of drug, amount of drug, drug formulation, dosage information, expiration, prescription 9 information, and storage information, etc., can also be associated with captured images and/or drug unit image data. Such additional information can be associated with the captured image at 11 the time of image capture or at any time subsequent to image capture.
12 Image and/or any image-related data will be securely maintained. Secure maintenance of 13 the image data and any image-related information can be performed by, for example, the drug 14 manufacturer or company, a trusted third party or service, or any other secure intermediary.
In a preferred embodiment, image capture occurs upon the initial production of each 16 randomly marked drug unit at the manufacturing plant, and as soon as possible after the random 17 markings are "fixed," or static.
18 In another preferred embodiment, the images are captured under particular controlled 19 environmental, lighting, flow rate, production, and/or throughput conditions. Image capture, according to the present invention, can be accomplished in production environments involving 21 high-speed and high volumes of individual drug units. In an alternative embodiment, image data 22 for marked drug units is captured for slowed, stalled, still, or non-moving drug units.
23 In addition to image capture, the present invention can include the use of conventional 24 optical and/or pattern recognition technology based on captured images to authenticate, verify, and track marked drug units. Such optical and/or pattern recognition and image analysis can be 26 performed for one or more images corresponding to each marked drug unit.
The optical and/or 27 pattern recognition and image analysis can be performed for each marked drug unit regardless of 28 whether the drug unit has a flat, non-flat, regular, irregular, curved, three-dimensional, smooth, 29 non-smooth, shaped, bumpy, etched, or otherwise non-uniform surface. In a preferred embodiment, the optical and/or pattern recognition technology can properly orient, compare, 31 and/or combine or match images relating to the same drug unit but captured from different 32 angles or perspectives relative to the drug unit and/or using only a portion of a marking.

1 The optical and/or pattern recognition and image analysis can involve any one or more of 2 several characterization/analysis techniques. For a given marked drug unit, this includes, but is 3 not limited to, measuring the distance of a random spot(s) center to edge of a drug unit, 4 determining the equation of a line drawn from marking fragment to marking fragment; basing analysis on a grid x,y location, basing analysis on vector length and radius angle from the center 6 point of the drug unit, etc. The optical and/or pattern recognition and image analysis can occur 7 at any time contemporaneous with, or after, the one or more images of the drug unit are captured.
8 The optical and/or pattern recognition technology and the implementing electronics, 9 computers, computer programs, computer applications, software, wireless, and/or mobile technologies and applications used with the present invention can also be especially adapted to 11 interface with each randomly marked drug unit and captured image data and/or image-related 12 data as discussed further below.
13 3. Secondary Product Identifiers 14 The present invention may also be synergistically used with additional separable marked product packaging, product labels, and/or other secondary product identifiers for drug product 16 tracking and authentication (e.g., QR codes, bar codes, RFID systems, etc.). Such secondary 17 product identifiers are conventionally used. The present invention, however, also contemplates 18 the incorporation of additional secondary product identifiers yet to be developed.
19 4. Security The present invention provides for varying and customizable levels of security and 21 includes numerous low security, medium security, and high security embodiments. It is 22 understood that myriad variations of the examples noted below are within the scope of the 23 present invention.
24 According to the present invention, any drug unit image data is securely stored. For example, drug unit image data can be stored in a secured database. In a preferred embodiment, 26 access to, and use of, the secure drug unit image data is triggered by user request. The present 27 invention allows one or more of any of the drug unit manufacturer, the drug unit provider, the 28 drug unit distributor, the drug unit retailer, the drug unit dispenser, and/or the drug unit consumer 29 to set one or more of varying security levels.
In one preferred embodiment, the drug unit manufacturer sets a minimum security level 31 that may be heightened by a downstream drug unit recipient seeking greater assurance as to drug 32 unit authenticity.

1 An example of a low security embodiment that excludes the use of machine-aided vision 2 or optics, but instead involves readily accessible human visual verification, provides that: (1) the 3 user provides secondary product identifier information associated with the product packaging for 4 a drug unit to an internet website; (2) the user receives a response that includes one or more drug unit images associated with the secondary product identifier information; and (3) the user makes 6 a visual comparison of the drug unit with the one or more drug unit images to determine 7 authenticity of the drug unit.
8 An example of a medium security embodiment involving visual and exchanged image 9 data verification provides that: (1) the user provides secondary product identifier information associated with the product packaging for a drug unit and a photograph of the drug unit to an 11 interne website; (2) the user receives a response regarding the authenticity of the drug unit that 12 includes both a machine-vision analysis of the drug unit photograph provided by the user as 13 compared to the captured image data for the drug unit and one or more drug unit images from a 14 captured image database; and (3) the user, optionally, separately makes a visual comparison of the drug unit with the one or more drug unit images from the captured image data database to 16 determine authenticity of the drug unit.
17 Another example of a medium security embodiment involving visual and exchanged 18 image data verification provides that: (1) the user provides secondary product identifier 19 information associated with the product packaging for a drug unit to an interne website; (2) the user takes a drug unit photograph that is analyzed by the user's image capture device; (3) the 21 user's image capture device sends the analyzed image data to an internet website; (4) the 22 analyzed image data prepared by the user's image capture device is compared to the captured 23 image information for the drug unit in or from the captured image database; (5) the user receives 24 a response regarding the authenticity of the product from the interne website and one or more drug unit images from the captured image database; and (6) the user, optionally, separately 26 makes a visual comparison of the drug unit with the one or more drug unit images from the 27 captured image database to determine authenticity of the drug unit.
28 Still another medium security embodiment additionally involves user-specific 29 identification, which may include requiring that a user access code based on the product serial number be allocated to the specific person to have custody of the product before any drug unit 31 image data is provided for comparison.
32 An example of a high security embodiment involves a secondary product identifier and 33 exchanged image data verification as noted above in the medium security embodiments, and 1 further involves requiring that a public encryption key be sent to an interne website along with a 2 photograph of the user. In this high security embodiment, the public encryption key is matched 3 to a private database key, and the photograph of the user is identity-matched to stored image 4 information for the user. The user may be presented with the drug unit image data and the user image identity comparisons between the user-provided information and the private database may 6 be shown side by side. Optionally, as presented, the compared image data may receive a 7 numerical estimate of authentication match, such as "99.3% match" or a statement such as 8 "accuracy of estimate is to within one of 48 billion."
9 Another example of a high security embodiment involves performing the drug unit authentication at a secure location. That is, the secure location includes any tools involved in the 11 authentication including, for example, scanning (if necessary) the secondary product identifier 12 and taking a photograph of the drug unit and, optionally, taking an identification photograph of 13 the user. This securely obtained information is then compared to stored image information for 14 the drug product, drug unit, and, optionally, the user. For example, the secured locations may be any of a pharmacy, hospital, clinic, distribution center, retailer, etc.
16 Whenever there is no match between compared images and/or image data, or a negative 17 response is generated, a text message, website address or link, or telephone 1-800 hotline may be 18 provided to the user to report the potential counterfeit product. The drug unit company and/or 19 appropriate authorities may also be notified. Cash rewards or other incentives can be provided to the user to report and/or deliver the counterfeit material to an appropriate entity.
21 5. Systems 22 Computer programs, software, applications, electronic systems, and methods, including 23 wireless and mobile applications, are part of the present invention.
24 In a preferred embodiment, the invention relates to a system involving:
random integrated optical marking of individual drug product units and secondary product identifiers 26 (e.g., QR codes, bar codes, RFID systems, etc.); captured, analyzed, stored, transmitted, and/or 27 compared drug unit image data; and remote devices (such as smart phones, etc.) used for drug 28 unit authentication.
29 Systems of the present invention can involve one or more computers, servers, computer programs, computer applications, wireless or mobile devices, electronic systems, software 31 programs and/or applications, and/or the like, to authenticate, verify, and track marked drug units 32 at multiple locations and/or over time by capturing, analyzing, storing, encrypting, 33 communicating, and/or comparing drug unit image data.

1 In a preferred embodiment, drug unit image data is captured, analyzed, stored, and 2 encrypted in a first location and the drug unit image data is communicated between and/or 3 compared at at least a first location and a second location. In another embodiment, drug unit 4 image data is captured, analyzed, stored, and optionally encrypted, in both a first location associated with drug unit creation and a second separate location associated with user 6 authentication.
7 Communication and comparison of the drug unit image data can occur using public 8 and/or private channels and can occur at one or more of any number of locations. In a preferred 9 embodiment, communication and comparison of drug unit image data is done over the internet and involves at least one secured drug unit image data location. Locations according to the 11 present invention can be numerous and are not geographically limited.
12 The present invention comprises a system for drug authentication comprising: a uniquely 13 marked individual drug dosage form; one of optical and pattern recognition technology; and one 14 of a computer, computer program, computer application, and/or software to collect, analyze, store, encrypt, transmit, or communicate information related to the uniquely marked individual 16 drug dosage form. The unique mark of the individual drug dosage form is an integral part of the 17 drug dosage form. The unique mark of the individual drug dosage form is one of on the surface 18 of, impregnated within, and distributed throughout the drug dosage form.
The optical or pattern 19 recognition technology includes imaging information specific to the uniquely marked individual drug dosage form. The imaging information is collected from a three-dimensional surface of the 21 uniquely marked individual drug dosage form.
22 A preferred embodiment the present invention, however, relates to a secure drug system 23 comprising:
24 integral security marking directly on the surface of, impregnated on the surface of, or otherwise within the drug products themselves;
26 individual unique integral security marking for each solid and/or semi-solid drug dosage 27 unit, including, but not limited to, pills, tablets, capsules, lozenges, wafers, patches, therapeutic 28 bandages, suppositories and/or other solid absorbables for external or internal use in a human or 29 animal subject;
individual unique integral security marking for each production lot, batch, or other such 31 production unit comprising solid or semi-solid drug dosage forms;
32 individual unique integral security marking materials comprising one or more inks, dyes, 33 and/or color additives, including but not limited to, alumina (dried aluminum hydroxide), annatto 1 extract, calcium carbonate, canthaxanthin, caramel, 13-carotene, cochineal extract, carmine, 2 potassium sodium copper chlorophyllin (chlorophyllin-copper complex), dihydroxyacetone, 3 bismuth oxychloride, synthetic iron oxide, ferric ammonium ferrocyanide, ferric ferrocyanide, 4 chromium hydroxide green, chromium oxide greens, guanine, mica-based pearlescent pigments, pyrophyllite, mica, talc, titanium dioxide, aluminum powder, bronze powder, copper powder, 6 zinc oxide, FD&C Blue No. 1, FD&C Blue No. 2, D&C Blue No. 4, FD&C Green No. 3, D&C
7 Green No. 5, D&C Green No. 6, D&C Green No. 8, D&C Orange No. 4, D&C
Orange No. 5, 8 D&C Orange No. 10, D&C Orange No. 11, FD&C Red No. 3, FD&C Red No. 4, D&C
Red No.
9 6, D&C Red No. 7, D&C Red No. 17, D&C Red No. 21, D&C Red No. 22, D&C Red No. 27, D&C Red No. 28, D&C Red No. 30, D&C Red No. 31, D&C Red No. 33, D&C Red No.
34, 11 D&C Red No. 36, D&C Red No. 39, FD&C Red No. 40, D&C Violet No. 2, FD&C
Yellow No.
12 5, FD&C Yellow No. 6, D&C Yellow No. 7, Ext. D&C Yellow No. 7, D&C
Yellow No. 8, D&C
13 Yellow No. 10, D&C Yellow No. 11, and/or other U.S. Food and Drug Administration approved 14 color additives;
individual unique integral security marking materials comprising one or more inks, dyes, 16 and/or color additives as applied in a particular sequential order, series, combination, and/or 17 generally conforming to a general design or pattern, etc.;
18 individual unique integral security marking materials comprising one or more inks, dyes, 19 and/or color additives, wherein the inks, dyes, and/or color additives are visible or invisible to the naked human eye, and/or visible or invisible with the aid of technology-enhanced vision or 21 computer-aided vision;
22 optical and/or pattern recognition technology and computers, computer programs, 23 computer applications, and/or software to interface with the individual unique integral security 24 marking;
optical and/or pattern recognition technology and computers, computer programs, 26 computer applications, and/or software to interface with the individual unique integral security 27 marking, wherein each individual unique integral security marking may be in one or more 28 various colors;
29 optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security 31 marking, and to analyze, capture, store, and/or compare an image and/or information associated 32 with the individual unique integral security marking;

1 optical and/or pattern recognition technology and computers, computer programs, 2 computer applications, and/or software to interface with the individual unique integral security 3 marking, to analyze, capture, store, encrypt, and/or compare an image and/or information 4 associated with the individual unique integral security marking, and to transmit, relay, encrypt, and/or communicate the image and/or information with one or more other computers, including 6 mobile devices such as smart phones, etc.;
7 optical and/or pattern recognition technology and computers, computer programs, 8 computer applications, and/or software to interface with the individual unique integral security 9 marking, to analyze, capture, store, encrypt, and/or compare an image and/or information associated with the individual unique integral security marking, to transmit, relay, encrypt, 11 and/or communicate the image and/or information to and/or from a first location of image and/or 12 information analysis, capture, storage, and/or comparison to and/or from a second location 13 involving one or more computers and/or devices that are local and/or distant;
14 optical and/or pattern recognition technology and computers, computer programs, computer applications, and/or software to interface with the individual unique integral security 16 marking, to analyze, capture, store, encrypt, and/or compare an image and/or information 17 associated with the individual unique integral security marking, to transmit, relay, encrypt, 18 and/or communicate the image and/or information to and/or from a first location of image and/or 19 information analysis, capture, storage, encryption, and/or comparison to and/or from a second location involving one or more computers and/or devices that are local and/or distant, wherein 21 the transmission, relay, and/or communication is via a private network and/or via the internet and 22 may, or may not, involve one or more computers, servers, andJor mobile devices;
23 optical and/or pattern recognition technology and computers, computer programs, 24 computer applications, and/or software to interface with the individual unique integral security marking, to analyze, capture, store, encrypt, and/or compare an image and/or information 26 associated with the individual unique integral security marking, to transmit, relay, encrypt, 27 and/or communicate the image and/or information to and/or from a first location of image and/or 28 information analysis, capture, storage, encryption, and/or comparison to and/or from a second 29 location involving one or more computers and/or devices that are local and/or distant, wherein the transmission, relay, and/or communication is via a private network and/or via the internet and 31 may, or may not, involve one or more computers, servers, and/or mobile devices, and wherein 32 the second location also includes an optical and/or pattern recognition technology and 33 computers, computer programs, computer applications, and/or software to interface with the 1 .. individual unique integral security marking to authenticate, encrypt, verify, and track the marked 2 product;
3 optical and/or pattern recognition technology and computers, computer programs, 4 .. computer applications, and/or software such as that described above available in a web-based .. application for use on mobile devices, including smart phones, etc.;
6 optical and/or pattern recognition technology and computers, computer programs, 7 .. computer applications, and/or software to interface with the individual unique integral security 8 .. marking, wherein each individual unique integral security marking may be on a non-flat, three-9 .. dimensional, smooth, or non-smooth surface;
a controlled environment optical and/or pattern recognition technology and software, 11 .. wherein the controlled environment may involve particular lighting, high-speed, high volumes, 12 .. and/or high throughput;
13 any method of practicing the invention involving any of the various embodiments 14 .. described above;
any method of practicing the invention involving any of the various embodiments 16 .. described above to counter, prevent, or reduce the counterfeit drug trade;
17 any method of practicing the invention involving any of the various embodiments 18 .. described above to assure an end user subject that the drug they have is authentic and its origin 19 .. and history is known; and any method of practicing the invention involving any of the various embodiments 21 .. described above wherein a user of a computer and/or mobile device, including an individual 22 .. patient, doctor, or pharmacist, can authenticate, verify, and track a product marked and analyzed 23 .. in accordance with this invention.
24 6. Methods Recipients of drug units marked with random optical integrated identification markings, 26 .. such as patients, pharmacists, hospitals, clinics, physicians, nurses, etc., can use secondary 27 .. product identifiers associated with the drug units, hardware incorporating or implementing 28 .. appropriate computer software, computer applications, computer programs, wireless 29 .. technologies, mobile applications, and an "internet website" to use drug unit image data, for .. comparing and authenticating the drug units.
31 In one preferred embodiment, recipients use visual image data corresponding to 32 .. secondary product identifiers to visually verify and confirm drug unit authenticity without 33 .. machine-aided or computer-aided vision. For example, a user may obtain one or more captured 1 image photographs corresponding to the drug unit and, simply by looking, authenticate the drug 2 unit.
3 In another embodiment, downstream drug unit recipients can use machine-aided or 4 computer-aided assistance together with secondary product identifiers associated with the drug product to optically compare, verify, and confirm drug unit authenticity based on drug unit image 6 data. For example, a downstream recipient may take and send one or more photographs 7 corresponding to the drug unit for comparison to potentially corresponding drug unit image data 8 to authenticate the drug unit.
9 The present invention includes any method of practicing the invention according to any disclosure provided in this application including any of the various embodiments described 11 above. The present invention also includes any method of practicing the invention to counter, 12 prevent, or reduce the counterfeit drug trade. The present invention also includes any method of 13 practicing the invention to ensure drug unit authenticity and provide confidence to a user that the 14 drug they have is authentic and its origin and history is known.

Claims

The invention claimed is:

1. A drug unit authentication system, comprising: a plurality of drug units, each drug unit containing a drug common to the plurality of drug units, and each drug unit having a deposited random integrated optically identifiable marking on a surface of or within a drug unit, wherein the marking of each drug unit in the plurality of drug units is unique and differentiatable from the markings of all other of the drug units in the plurality of drug units; drug unit image data unique for each of the plurality of drug units and being related to the unique and differentiatable marking of each of the plurality of drug units; a secondary product identifier common to the plurality of the drug units and related to the common drug of the plurality of drug units; and a comparator configured to perform an optical comparison of a selected one of the drug units and the drug unit image data associated with the selected one of the drug units.

2. The system of claim 1, wherein the deposited random integrated optically identifiable marking includes one or more of dots, spots, shapes, splashes, sprays, splatters, speckles, threads, and granules.

3. The system of claim 1, wherein the deposited random integrated optically identifiable marking is both on a surface of and within the drug unit.

4. The system of claim 1, wherein the drug unit image data comprises information based on the deposited random integrated optically identifiable marking.

5. The system of claim 4, wherein the drug unit image data further comprises information associated with the secondary product identifier.

6. The system of claim 4, wherein the drug unit image data further comprises information associated with drug unit production details.

7. The system of claim 1, wherein the secondary product identifier is on or within a removable component associated with the drug unit.

8. The system of claim 1, wherein the secondary product identifier is one of a quick response code, bar code, and a radio-frequency identification system.

9. The system of claim 1, further comprising customizable security levels.

10. The system of claim 1, wherein the system comprises human-readable drug unit image data.

11. The system of claim 1, further comprising one of electronic, computer, mobile, wireless, and web-based technologies.

12. The system of claim 1, wherein the drug unit image data comprises information based on one of optical and pattern recognition technologies.

13. A drug unit authentication system, comprising a plurality of drug units, each drug unit containing a drug common to the plurality of drug units, and each drug unit having a deposited random integrated optically identifiable marking on a surface of or within a drug unit, wherein the marking of each drug unit in the plurality of drug units has a size, shape, location or distribution unique and differentiatable from the markings of all other of the drug units in the plurality of drug units, wherein each drug unit in the plurality of drug units has a secondary product identifier common to the plurality of the drug units and related to the common drug of the plurality of drug units, wherein the marking is configured for use in a comparison of a selected one of the drug units and drug unit marking data associated with the selected one of the drug units and being related to the markings and the secondary product identifier for the selected one of the drug units.

14. The system of claim 13 wherein the deposited random integrated optically identifiable marking includes one or more of dots, spots, shapes, splashes, sprays, splatters, speckles, threads, and granules.

15. The system of claim 13 wherein the deposited random integrated optically identifiable marking is both on a surface of and within the drug unit.

16. The system of claim 13, further comprising a comparator configured to perform an optical comparison of the selected one of the drug units and the drug unit marking data.

17. The system of claim 13, further comprising a comparator configured to perform pattern recognition comparison of the selected one of the drug units and the drug unit marking data.

18. The system of claim 17 wherein the comparator performs pattern recognition based upon one or more equations of lines between portions of the integrated optically identifiable marking, as a function of vector length and radius angle relative to a selected frame of reference.

19. The system of claim 13 wherein the drug unit marking data comprises image information based on the deposited random integrated optically identifiable marking.

20. The system of claim 13 wherein the drug unit marking data further comprises information associated with the secondary product identifier.

21. The system of claim 13 wherein the secondary product identifier is a quick response code, bar code, or a radio-frequency identification system.

22. The system of claim 13, further comprising human-readable drug unit marking data.

23. The system of claim 13, further comprising human-readable drug unit image data.

24. The system of claim 13 wherein the drug unit marking data comprises image data unique to a single one of the plurality of drug units based upon an image of the marking of single one of the plurality of drug units.

25. A drug unit authentication system for use with a plurality of drug units containing a common drug, and comparator that uses drug unit identifier information, comprising: a drug unit having a deposited random optically identifiable marking on a surface of or within the drug unit of the plurality of drug units, wherein the marking has a size, shape, location or distribution unique and differentiatable from the markings of all other of the drug units in the plurality of drug units, wherein the drug unit has a secondary product identifier common to the plurality of drug units and related to the common drug of the plurality of drug units, wherein the marking is configured for use by the comparator in a comparison of the drug unit and drug unit marking data associated with the drug unit and being related to the markings and the secondary product identifier for a selected one of the drug units to differentiate the drug unit from all other drug units in the plurality of drug units.

26. The system of claim 25, wherein the deposited random integrated optically identifiable marking includes one or more of dots, spots, shapes, splashes, sprays, splatters, speckles, threads, and granules.

27. The system of claim 25, wherein the deposited random integrated optically identifiable marking is both on a surface of and within the drug unit.

28. The system of claim 25, wherein the drug unit marking data comprises information based on the deposited random integrated optically identifiable marking.

29. The system of claim 28, wherein the drug unit marking data further comprises information associated with the secondary product identifier.

30. The system of claim 28, wherein the drug unit marking data further comprises information associated with drug unit production details.

31. The system of claim 25, wherein the secondary product identifier is on or within a removable component associated with the drug unit.

32. The system of claim 25, wherein the secondary product identifier is one of a quick response code, bar code, and a radio-frequency identification system.

33. The system of claim 25, wherein the drug unit marking data comprises information based on one of optical and pattern recognition technologies.

34. A uniquely identifiable drug unit product, comprising a drug unit having a common drug and a deposited random optically identifiable marking on a surface of or within the drug unit, wherein the marking has a size, shape, location or distribution unique and differentiatable from marking of all other drug units of a plurality of drug units containing the common drug, wherein the drug unit has a secondary product identifier common to the plurality of the drug units and related to the common drug, wherein the marking is configured for use in a comparison and differentiation of the drug unit and drug unit marking data associated with the drug unit to all other drug units in the plurality of drug units.

35. The product of claim 34 wherein the secondary product identifier is located on a removable component associated with the drug unit.

36. The product of claim 34, wherein the deposited random optically identifiable marking is on a surface of and within the drug unit.

37. The product of claim 34, wherein the deposited random optically identifiable marking includes one or more of dots, spots, shapes, splashes, sprays, splatters, speckles, threads, and granules.

38. The product of claim 34, wherein the drug unit marking data comprises information based on the deposited random integrated optically identifiable marking.

39. The product of claim 34, wherein the drug unit marking data further comprises information associated with the secondary product identifier.

40. The product of claim 39 wherein the drug unit marking data further comprises information associated with drug unit production details.

41. The product of claim 34 wherein the secondary product identifier is one of a quick response code, bar code, and a radio-frequency identification system.