Patent Application
20150183257
The present invention relates to anti-counterfeiting measures used with pharmaceuticals, and more specifically, is related to measures used with blister-style and other types of packaging used with pharmaceuticals.
The state of the art in anti-counterfeiting for pharmaceutical tablet blister packaging includes overt and covert features. Currently used anti-counterfeiting methods include the following:
Serialization of drug packaging is now starting to be widely implemented on pharmaceutical production lines in Europe and the U.S. There are different systems being tested and these allow different levels of checking in the supply chain. Furthermore, different database monitoring methods are being tested and monitored. Who should control and fund these control systems and exactly how they should work remains a matter of discussion. See, e.g., The European Serialization Landscape, by Mark Davidson, Blue Sphere Health Ltd, Cambridge, U.K., May 2012. The U.S. and Europe have different approaches to the issue of serialization and so-called “track & trace.” The European system allows checking even at the dispensing level. The U.S. system allows checking only when a transfer of ownership occurs. See e.g., Serialization—EU's track & trace vs. US's E-pedigree, by Jim Chrzan, Healthcare Packaging, March 2013 (http://www.healthcarepackaging.com/trends-and-issues/traceability-and-authentication/serialization-eus-track-and-trace-versus-uss-e).
Hologram technology where the hologram is applied using plastic and metalized film materials is well established. An example is the well-known holograms on credit cards.
An example of the printed code or barcode verified by phone/text is the Sproxil system currently in use in parts of Africa and other developing countries. See e.g., Powered by Mobile Technology to Combat Counterfeiting (http://sproxil.com/sms-verification.html).
Serialization has the disadvantage that it requires a database and that it is complex to implement. One issue to be resolved is ownership, management of, and access to the database, to ensure that the information is readily accessible and yet secure against compromise. See e.g., Anti-counterfeit Technologies for the Protection of Medicines, World Health Organization IMPACT report (http://www.who.int/impact/events/IMPACT-ACTechnologiesv3LIS.pdf). Another issue is that printed barcodes are easy to create and there is no guarantee that the genuine barcode will reach the dispenser before the counterfeit barcode.
Holograms, especially those on packaging films, have the disadvantage that a hologram can be easily obtained which may make a product look genuine when it is not. If a customer or distributor is not informed and careful enough to be able to distinguish the genuine hologram from the fake hologram, any similar hologram can give false assurance.
Special inks are printable by anyone who can obtain them, and can be used to print a copy of similar information that would be present on the genuine article.
Taggants are only verifiable by specific equipment with the correct technology to reveal them. This makes them expensive to use and means that for verification, the packaging has to be sent to a special laboratory.
The mobile-phone verifiable printed codes and barcode scans are open to counterfeiters who are able to generate fake codes and verification numbers, or fake websites that the fake barcodes link to. Counterfeiters will go to considerable effort to make fake sites appear overtly genuine.
Thus, it is desirable to improve anti-counterfeiting measures used in this field, especially with pharmaceuticals that may travel through supply chain points in poorer regions of the world. More specifically, it is desirable to provide a reliable low-cost authentication process that may be used with pharmaceuticals at any position along the supply chain between the initial manufacturer and the final consumer.
In one embodiment according to the disclosed invention, a method is provided for discouraging counterfeiting of pharmaceutical products. The method includes providing a packaging with a genuine pharmaceutical and with a hidden security feature formed integrally by material defining the packaging. The method also includes verifying the authenticity of the pharmaceutical by directing a laser beam through the packaging at the hidden security feature. This directing of the laser beam reveals the hidden security feature on a surface behind the packaging. Therefore, a simple and rapid authentication of the pharmaceutical can be conducted at any point in the supply chain between the manufacturer and the end consumer, using only inexpensive equipment like a conventional laser pointer.
In some aspects, the packaging is further provided with one or more additional security features that may be confirmed visually or with a machine during authentication of the pharmaceutical. The additional security features in combination with the hidden security feature collectively define a unique digital signature for the packaging that may be tracked as required by some local regulations and laws. The additional security features in some embodiments include one or more of: microtext defining depth and lateral dimensions between 2 microns and 100 microns; a hologram acting as an overt security feature on the packaging; and a barcode located on the packaging or on an outer packaging box into which the packaging is typically loaded for transfer along the supply chain. Such a barcode may also independently provide identification and/or serialization functionality to comply with local regulations and laws.
When the additional security features include a hologram, that hologram may provide one or more levels of additional security verification features. In this regard, the hologram in one embodiment diffracts light differently at different viewing angles to visually change color at the different viewing angles. In further embodiments, the hologram also diffracts light so as to present a first image (like a globe) at some viewing angles and a distinct second image (like a set of meridians and parallels) at other viewing angles. In still further embodiments, the hologram also includes the hidden security feature and/or a detectable irregularity formed integrally within the hologram. The hidden security feature is revealed by the laser beam, while the detectable irregularity is covert but identifiable with a 3D scanner. These additional security levels provide further challenges to potential counterfeiters above and beyond the hidden security feature revealed only by laser pointer.
The packaging used with these methods may define different form factors to suit the practices of various countries. To this end, the packaging in one aspect includes a blister pack with a foil coating. A portion of the foil coating must be removed adjacent to the hidden security feature to enable the laser beam to be directed through the packaging to reveal the hidden security feature. In other aspects, the packaging includes a pill bottle with a closure cap, the hidden security feature being provided in one or both of the pill bottle and the closure cap. The process of verifying the authenticity of the pharmaceutical with the laser beam is performed within 1 second without reliance on communication with external databases during the verifying of the authenticity. Therefore, the method provides sufficient protections from counterfeiting efforts while also enabling simple and inexpensive authentication to be performed at all locations in a supply chain, even when in poorer countries or regions.
In another embodiment according to the disclosed invention, a pharmaceutical product is configured to discourage counterfeiting. The product includes one or more dosage forms and a packaging configured to receive and securely hold the one or more dosage forms. The packaging is defined by a material and includes a hidden security feature that is formed integrally by the material defining the packaging. The hidden security feature deflects laser energy transmitted through the packaging such that a laser beam directed through the packaging at the hidden security feature reveals the hidden security feature on a surface behind the packaging to thereby verify the authenticity of the pharmaceutical. The pharmaceutical product may also include the additional security features and different types of packaging as described above.
These and other objects and advantages of the disclosed apparatus will become more readily apparent during the following detailed description taken in conjunction with the drawings herein.
The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and, together with the general description above, and the detailed description of the embodiments below, serve to explain the principles of the invention outlined in this disclosure.
According to the embodiments of the disclosed invention, a packaging for pharmaceutical products is provided with covert and/or overt security features which may be used to authenticate or verify the authenticity of the pharmaceutical product at various locations along a typical supply chain for the pharmaceutical. To this end,
With continued reference to
In one embodiment shown in
To produce this hidden security feature 20, a diffractive optical grating pattern is embossed into the surface of the PVC blister pack 24. This takes place as part of a normal in-line pharmaceutical tablet packaging process on a blister-packaging machine. A standard embossing station 50 on the machine, such as that previously designed for embossing batch codes, can be used to emboss the diffractive grating structure (
If desired, an overtly visible hologram 34 can be produced during the same manufacturing process that can be seen brightly in sunlight or white artificial lighting (
Tooling for the embossing process may be manufactured by applying the diffractive structure needed into a hardened tool steel insert 56 (
In addition to the hidden security feature, the tooling and embossing process used allows for complex holograms 60, for example showing different images in different viewing orientations, to be produced and embossed. This process also allows for further types of diffractive structures to be produced in the steel and embossed, including random structures and Moiré structures.
The hidden information revealed by the laser pointer 22, through the reconstruction of the image hidden in the diffractive optics, can include any kind of lettering or pattern. For example, it can be a logo, or 2-D bar code pattern that can be photographed and decoded. In another example, the lettering is in the form of microtext 36 having depth and/or lateral dimensions between 2 microns to 100 microns.
One advantage of these embodiments is allowing the hidden security feature 20 on the blister pack 24 to be verified using a simple laser pointer 22. The verification can be done by the manufacturer 14 (without informing the end consumer 18 that the feature is there) or by others in the supply chain 10 including the end consumer 18, who can verify the feature if the manufacturer 14 chooses to inform them of its presence, the location where it can be found on the packaging 24, and how it can be checked. Furthermore, the laser pointer 22 revealing of the hidden security feature 20 is nearly instantaneous and does not require communication with an external database, thereby enabling one type of verification of the pharmaceutical product 12 to be performed in less than 1 second of time (by contrast, sending scanned codes to an external database and waiting for verification takes a few seconds, at minimum, for each packaging 24).
The use of the hidden security features 20 enables easy checks at any point in the supply chain 10, including in poorer countries, where laser pointers 22 can be purchased. The conventional mobile phone authentication method described in the background allows for supply chain 10 checks but is subject to the abuses of the system described above (fake verification websites for fake codes), and also requires cost-prohibitive mobile phone technology to be accessible at each point in the supply chain 10. Allowing consumers 18 the possibility to check a genuine product 12 themselves means that even internet-purchased blister packages 24 of drugs can be checked for authenticity. This, and allowing checks at different supply chain points even in poorer countries, is fully in accordance with one of the recommendations from the United Nations Institute for Interregional Crime and Justice Research Institute (UNICRI), as a result of the European research project “SAVEmed.” See, e.g., www.savemed.org.
Because the hidden security feature in these embodiments is integrally formed as a unitary piece with the plastic material 42 and is embossed into the packaging 24, the verification cannot be faked by applying another hologram 34, 60 or film. In addition, the hidden security feature 20 cannot be removed or rewritten in any way.
Another advantage of these embodiments is that the hidden security feature is very hard to copy. In order to create the same feature, the counterfeiter would have to be able to copy the diffractive optical design from the surface of the blister pack 24 (this is only possible using special technology and special materials in high technology laboratories). The counterfeiter would then also have to be able to make a similar embossing stamp to generate the hidden security feature 20 and other features on the blister packaging machinery, which can be complex and difficult.
The hidden security feature can be concealed as part of an overt hologram 60 or combined with an embossed barcode. This may lead the counterfeiter to copy the overt feature without realizing that the covert feature is present in the same area of the package.
A further advantage is that the hidden security feature can be designed to include a 2D barcode (e.g., the hidden information 46) that is revealed by the laser pointer 22. In principle, it is possible to write a software application, such as a mobile phone application, for example, to scan the barcode and read the 2D barcode. The barcode itself can contain encrypted information allowing for a range of security enhancements.
Because the verification is within the blister pack 24 itself, no database access or database management is needed for performing the authentication or verification of the blister pack 24. More specifically, verification codes and data do not need to be sent to external databases for verifying the authenticity of a blister pack 24 and its contents. As a result, verification of the blister pack 24 occurs immediately upon illumination of the hidden security feature 20 with the laser pointer 22, which means blister packs 24 are verified as authentic within one second. Conventional systems reliant on communication with external servers do not compare favorably with the time efficiency offered by this anti-counterfeiting and authentication process.
As no additional materials are added to the packaging 24, the only additional cost to the manufacturer 14 is the embossing tooling containing the diffractive structure. A further advantage of this is that the pharmaceutical manufacturer 14 has no additional approvals or documentation to complete because of changes to the materials or process steps.
Packaging Different from Blister Packs
The embodiments described herein are potentially useful also in markets where—to date—the majority of dosage form deliveries do not use blister packs 24 but where dosage forms are shipped in bulk and re-packaged along the supply chain 10. Although there is a certain trend in the United States to introduce blister packs 24, bulk-deliveries and re-packaging will still be possible after introduction of new serialization policies, beginning with California state law to become effective in 2015. The so-called electronic pedigree requires a “record, in electronic form containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer 14, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering or dispensing the dangerous drug. The pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution.” See California Business and Professions Code Section 4034 (a).
The rules regarding the pedigree do not, however, dictate the technological implementation of identifiers put onto pharmaceutical packaging, such as blister packs 24 or bulk packaging. In fact, the California government's written summary on e-pedigree laws says specifically: “The unique identifier . . . on each saleable container of prescription drugs will most likely be carried on either a 2D bar code or an RFID chip placed on the saleable unit by the manufacturer 14. The California Legislature has not mandated these specific technologies, but they are the two methods that have been identified that could meet the requirements of the legislation.”
It is therefore in the interest of U.S. pharmaceutical manufacturers, and all pharmaceutical manufacturers 14 selling products 12 in the United States—or the State of California for that matter—to select their specific technological implementation that will ensure compliance with the new serialization requirement.
The embodiments described herein not only are uniquely capable of achieving compliance by pharmaceutical manufacturers 14 with those new rules, but also are superior to the straightforward application of minimum coding requirements in the form of 2D bar codes or RFID chips, in that the application of additional overt and/or covert security features will easily allow the creation of full-scale digital finger-printing down to the product level (and integration into manufacturer supply chain management systems), should manufacturers 14, distributors 16 and consumers 18 desire even greater levels of security against counterfeiting. Several of these combinations are set forth in greater detail below.
Furthermore, as shown in
It will also be understood that the holographic or hidden security feature 20 may be combined with additional security features on the dosage form and/or the packaging. These additional security features further enhance the guard against counterfeiting of the packaging and of the pharmaceutical dosage forms themselves.
For example, the dosage form may include data matrix codes such as microstructured and nanostructured surfaces as disclosed in U.S. patent application Ser. No. 12/761,993 to Klocke et al., entitled “Manufacturing Solid Pharmaceutical Dosage Forms with Visible Micro- and Nanostructured Surfaces and Micro- and Nanostructured Pharmaceutical Dosage Forms,” which was filed Apr. 16, 2012 and the entirety of which is hereby incorporated by reference herein (most recently published as U.S. Patent Publication No. 2014/0255482).
In another example, the dosage form and the packaging may include complementary features for optical verification (man or machine), such as the Moire patterns formed in U.S. Pat. No. 8,323,623 to Klocke et al., entitled “Pharmaceutical Moire Pill,” and the entirety of which is hereby incorporated by reference herein.
Moreover, multiple structures may be used to provide additional optical contract or authentication/verification of the pharmaceutical and/or packing, as described in U.S. Pat. No. 8,715,725 to Stuck et al., entitled “Secure Tracking of Tablets,” and the entirety of which is hereby incorporated by reference herein, and also disclosed in U.S. Patent Publication No. 2011/0186629 to Stuck et al., entitled “Method For The Authentication of Dosage Forms,” which was filed Jan. 20, 2011 and the entirety of which is hereby incorporated by reference herein.
As briefly described above, a generalized example of one or more additional security features on the same blister pack 24 as the hidden security feature 20 is shown in
It will be understood that only one or any combination of these and other known types of overt security features may be located on the same blister pack 24 as the hidden security feature 20 in other embodiments consistent with the scope of this disclosure, the combination of all these security features collectively defining a unique digital signature for the blister pack 24. Therefore, in addition to the verification or authentication process enabled by shooting a laser pointer 22 through the hidden security feature 20, this unique digital signature may also be verified or authenticated at any point in the supply chain 10 for the pharmaceutical products 12.
Each of these additional security features may be used in any combination with the holographic overt and hidden security features described above, to further enhance the anti-counterfeiting measures.
In some embodiments, the hologram 60 embossed onto the blister package 24 can contain multiple levels of security verification. For example:
Level 1: Visual hologram image effect.
Level 2: Hologram image that changes with different viewing angle (e.g., a 90° or 180° turn).
Level 3: Hidden detail verification.
For an example of the Level 1 hologram verification, the embossing tool formed from a hardened steel insert 56 may be modified to include an embossing surface 58 configured to form such a hologram 60 in a blister pack 24 or other packaging (
An example of the Level 2 hologram verification may include a hologram security feature (described as element 78 below) that is embossed or otherwise applied to a blister pack 24 or similar packaging such that at a first angle of viewing, the hologram 78 presents a first image such as a globe, and at a second angle of viewing, the hologram 78 presents a second and distinct image such as 2D meridians and parallels forming a globe shape. A schematic illustration of this concept is provided at
As an example of the Level 3 verification, detectable irregularities such as microtext 36 or reflected diffractive patterns formed by gratings or other similar structures may be included in the hologram images as well. More particularly, on the surface, the hologram 78 consists of many superimposed periodic structures, such as gratings with lateral sizes of less than 6 microns, typically less than 2 microns. The depth of these structures is between 50 nanometers and 1 micron. The hologram 78 can cover a total area of 30 microns by 30 microns in size up to very large sizes (tens of square centimeters, if necessary). If a part of the hologram 78 does not contain any periodic structures, but is flat for example, the diffraction efficiency of the hologram 78 is decreased but the information within the hologram 78 is maintained and the hologram 78 can still be projected. Areas within the hologram 78 surface which are flat, for example can form a microtext 36. One preferable embodiment is to create a hologram 78 which upon projection by a laser displays a barcode (one or two dimensional), the barcode has open or cryptographically secured information about the product 12, for example, it might contain the name of the product 12, a tool number, a batch number, etc. Microtext 36 within the area of the hologram 78 may consist of small areas (e.g., 2 to 100 microns in size) that simply do not contain a holographic grating. In a preferred embodiment, the microtext 36 will be an alphanumeric sequence that acts as a digital signature for verification of the content of the barcode. A measurement device, such as a mobile phone, or a camera linked with a computer, will be able to read these features. These hidden elements associated with the hologram 78 are typically not overt and therefore will be difficult to copy for counterfeiters, much like the hidden security features 20 described in detail above.
In another preferred embodiment, the surface area of the hologram 78 is not flat, but modulated in height, for example it might contain two or more regions of different height (the height differences might vary between 0.1 micron and 100 microns). These areas can form for example a linear or 2 dimensional barcode where each area of the barcode contains grating lines that are included in the hologram 78. A preferred lateral size of this barcode will be between 5 microns and 500 microns. These height differences can be read with an accurate 3D scanner, such as an interferometer, a pOCT reader (optical coherence tomography), a confocal microscope, etc., to reveal the encoded information. In another example, the embossing tooling used to make the hologram 78 may include detectable small defects unique to the tooling, which may be read by 3D scanning equipment such as that described above to confirm that the authentic tooling placed the security feature hologram 78 on the product packaging 24. Regardless of what type of irregularity or defect is included with the hologram 78 as part of the Level 3 verification, the combination of security features enables further verification and authentication processes at various locations in the supply chain 10 for pharmaceutical products 12.
The multiple level hologram verification can be used as an alternative to, or in addition to, the hidden security features 20 revealed with a laser pointer 22.
While the present invention has been illustrated by a description of exemplary embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features of the invention may be used alone or in any combination depending on the needs and preferences of the user. This has been a description of the preferred methods of practicing embodiments of the invention as currently known. However, the invention itself should only be defined by the appended claims.
This application claims priority to U.S. Provisional Application Ser. No. 61/922,508, filed Dec. 31, 2013. This prior application is incorporated herein by reference, in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61922508 | Dec 2013 | US |
