Pharmaceutical products such as pills and capsules traditionally include a number of markings. Marks or printed information on pharmaceutical products typically include information such as logos, names, or bar codes that may be used to identify the type, dosage, and/or source of the pharmaceuticals. These markings also aid in the dispensing and administration of pharmaceuticals to patients.
In order to mark or otherwise label pharmaceutical products such as pills and capsules, the methodology has to be approved by the food and drug administration (FDA). The FDA has a number of lists containing approved colorants and labels that may be used to mark or otherwise label pharmaceutical products.
Traditional methods of marking pharmaceutical products such as pills and capsules include coloring the pharmaceutical products with FDA certified colorants, altering the surface appearance of the pharmaceutical products through engravings, applying a label to the surface of the pharmaceutical products, or painting the pharmaceutical product.
While traditional methods are somewhat effective in marking or otherwise distinguishing pharmaceutical products, traditional methods of marking pharmaceutical products significantly compromise the outward appearance of the pharmaceutical products. Additionally, traditional methods do little to facilitate the control of counterfeit production and fraudulent dispensing of pharmaceuticals, since these outer markings are easily identifiable and reproducible. Moreover, a majority of the traditional methods and formulations for marking or otherwise labeling pharmaceutical products necessitate contact with the pharmaceutical. Any such contact with the pharmaceutical products increases the likelihood of causing physical or chemical damage to the pharmaceutical product.
In one of many possible embodiments, a method for labeling a substrate includes positioning the substrate adjacent to a material dispenser, and selectively dispensing an edible ink onto the substrate with the material dispenser. The edible ink is configured to exhibit a known fluorescent emissive profile when exposed to an ultraviolet light.
The accompanying drawings illustrate various embodiments of the present system and method and are a part of the specification. The illustrated embodiments are merely examples of the present system and method and do not limit the scope thereof.
Throughout the drawings, identical reference numbers designate similar, but not necessarily identical, elements.
An exemplary system and method for forming a spectral fingerprint on an object to be tracked and/or verified is disclosed herein. More specifically, an ink is disclosed that is not visible to the naked eye under normal white light conditions; however, when irradiated with ultraviolet (UV) light (365-400 nm), the ink fluoresces and provides an identifiable spectral profile. According to one exemplary embodiment, the ink is non-toxic, edible, and made of compounds listed in the Generally Regarded as Safe (GRAS) list sponsored by the Food and Drug Administration (FDA) and configured to be applied to pharmaceutical products
As used in the present specification and the appended claim, the term “edible” ink is meant to be understood broadly as any composition that is suitable for human consumption and is non-toxic. Similarly, the phrase “edible ink” is meant to be understood as any ink that is suitable for human consumption and complies with applicable standards such as food, drug, and cosmetic (FD&C) regulations in the United States and/or Eurocontrol experimental centre (E.E.C.) standards in the European Union. Additionally, the term “invisible” is meant to be understood broadly as meaning any image, color, or shading that, when viewed by the naked eye, is not prominent or readily noticeable. The term “jettable” is meant to be understood both in the present specification and in the appended claims as any material that may be selectively deposited by any digitally addressable inkjet material dispenser.
In the following description, for purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the present system and method for optically tracking objects using a spectral fingerprint of fluorescent compounds. It will be apparent, however, to one skilled in the art, that the present method may be practiced without these specific details. Reference, in the specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearance of the phrase “in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment.
Exemplary Structure
Traditionally, the incorporation of a product name, a product coating color, and/or or product design has been used to discourage the production of counterfeit pharmaceuticals. However, the threat of counterfeit attacks, regulation, and possible liability are driving a desire for enhanced pharmaceutical authentication measures. According to one exemplary embodiment of the present system and method, a spectral fingerprint is formed with a number of fluorescent compounds to track and authenticate pharmaceuticals and other similar products.
As illustrated in
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A similar test was performed on a single drop of orange 5 ink, as illustrated in
Comparing the fluorescent emission profiles of the quinine ink illustrated in
As shown in
Selectively varying the number and type of ink drops in the linear array of drops will modify the resulting fluorescent emission profile, as is illustrated in
Exemplary Composition
According to one exemplary embodiment, the above-mentioned UV fluorescing inks are to be applied to pharmaceuticals. Consequently, according to this exemplary embodiment, the components of the UV fluorescing ink are edible, making the fluorescing inks edible inks, as defined herein. According to one exemplary embodiment, the present edible ink includes at least two main components: an ink vehicle and a colorant.
The ink vehicle component of the present edible ink provides a liquid solution that facilitates dispersion and dissolution of the colorant while enabling the selectively controlled transport of the colorant from a material dispenser to a pharmaceutical product or other printing substrate. Additionally, the ink vehicle can also act as a binder to affix the colorant to the pharmaceutical product or other print substrate. The components of the ink vehicle may be made of any edible compound with substantially non-visible properties when applied to a pharmaceutical product or other printing substrate. Examples of these compounds are listed in the Generally Regarded as Safe (GRAS) list sponsored by the food and drug administration (FDA). According to one exemplary embodiment, the ink vehicle includes at least a solvent, but may also include additives configured to enhance various properties and characteristics of the resulting ink. Property enhancing additives that may form a part of the ink vehicle may include, but are in no way limited to, surfactants, buffers, and/or humectants.
The solvent component of the ink vehicle is included in the present edible ink for dispersion and transport of the colorant as well as any additives. The vehicle solvent, according to one exemplary embodiment, imparts a jettable viscosity to the edible ink while also evaporating at a rate sufficient to make a printed image resistant to smudging soon after it is deposited on a pharmaceutical product or other ink receiving substrate. According to one exemplary embodiment, the solvent comprises water, thus creating a water-based vehicle. In addition to low cost, water is effective as a solvent for many additives, greatly reduces inkjet dispenser compatibility issues, effectively suspends colorants, and effectively controls drying rates of the ink. More specifically, a water-based vehicle may comprise from 20% by volume water up to about 90% by volume water. In another exemplary embodiment, the solvent component of the ink vehicle includes a mixture of water and an alcohol, such as ethyl alcohol. The addition of an alcohol to a solvent affects the viscosity and drying rate of the ink vehicle, as well as acting as a surfactant.
Surfactants and emulsifiers may be added to the solvent component of the present edible ink in order to facilitate dispersion and/or dissolution of the colorant and any other additive in the solvent. Typically, an edible alcohol may be used as the vehicle surfactant including, but in no way limited to, ethyl alcohol, glycerol, methyl alcohol, isopropyl alcohol, and butyl alcohol. Ethyl alcohol, for example, decreases the surface tension of water, thereby allowing a colorant and other additives to dissolve and/or disperse throughout the water more easily. The ethyl alcohol may also facilitate the jettability of the present edible ink, according to one exemplary embodiment. Moreover, other edible compounds besides alcohols may also be used as the surfactant or emulsifier, including, but in no way limited to, lecithin, crillet, polyoxyethylene sorbitan monostearate (TWEEN), xanthan gum, sorbitol, and starches such as maize starch, corn starch, and potato starch. According to one exemplary embodiment, a surfactant or emulsifier may be present in a concentration of up to about 20% by volume of the ink vehicle. In one particular embodiment, the surfactant or emulsifier comprises ethyl alcohol in a concentration of about 17% to about 20% by weight. In another aspect, ethyl alcohol comprises from about 13% to about 17% by weight of the vehicle.
In addition to solvents, surfactants, and emulsifiers, the ink vehicle may also include a pH buffer to control the pH level of the edible ink. The pH level of the edible ink may be adjusted to vary, among other things, the fluorescence intensity of the colorant. According to one exemplary embodiment, an acid is used as a buffer to increase the acidity of the ink. Increasing the acidity level of the ink intensifies the fluorescence of some colorants, such as quinine sulfate, making the edible ink fluoresce brighter thereby making it more visible under UV light. The concentration of acid used may vary depending on the desired fluorescence intensity but typically comprises up to about 1% by weight of the vehicle. In one specific embodiment, the buffer comprises sulfuric acid in a concentration of about 0.4% by weight of the vehicle. In another embodiment, the acid is present in the vehicle in a concentration of about 5 milligrams per milliliter of water.
A humectant may also be included in the present ink vehicle to control the moisture content and viscosity thereof, according to one exemplary embodiment. The ink vehicle typically dries by evaporation once it is disposed on the pharmaceutical product or other substrate surface; however, drying prior to printing decreases viscosity and thus may inhibit the jettability of the edible ink. Therefore, a humectant may be included in the vehicle to keep the edible ink from premature drying. The humectant may include, but is in no way limited to glycerin, sorbitol, mannitol, or any other edible humectant. According to one exemplary embodiment, the humectant can be present in the vehicle in a concentration of up to approximately 5% of the vehicle by volume. According to another exemplary embodiment, the humectant includes glycerin in a concentration of approximately 3% by volume, or about 4% by weight, of the ink vehicle.
According to one exemplary embodiment, the vehicle component of the present edible ink may also include other additives as needed including, but in no way limited to, driers, thinners, waxes, lubricants, reducing oils and solvents, body gum and binding varnish, antioxidants and anti-skinning agents, resins, and/or binders.
The present edible ink also includes an edible colorant component configured to produce a desired emission profile when exposed to UV light. According to one exemplary embodiment, the colorant component is not visible to the human eye when applied to the pharmaceutical product or other substrate, either because it is colorless or because it is the same color as the pharmaceutical product or printing substrate. Suitable colorants include any edible compounds, or combinations thereof, that naturally fluoresce when exposed to UV light including, but in no way limited to, riboflavin, riboflavin phosphate including riboflavin 5′-phosphate, pyridoxine hydrochloride, folic acid, quinine sulfate, niacin, nicotinamide, D&C Orange No. 5, or any appropriate combination thereof. The afore-mentioned fluorescent colorants are also water-soluble, further facilitating their incorporation into a water-based ink vehicle.
While the above-mentioned exemplary compositions are configured for application to a pharmaceutical product, the above-mentioned edible ink may be used to mark, track, and authenticate any number products that may come in contact with a consumer's mouth including, but in no way limited to, food products, pharmaceutical coverings, or dental products. Additionally, the present system and method may be incorporated with objects not restricted by the food, drug, and cosmetic (FD&C) regulations in the United States and/or Eurocontrol experimental centre (E.E.C.) standards in the European Union. When applied to non-restricted components, the present marking ink may include any number of colorants that fluoresce when exposed to UV light.
The component concentrations mentioned above are merely given as examples and are in no way meant to limit the contemplated concentrations. Rather, the concentration of the colorant or other components can be lower if less intense fluorescence is desired or higher if more intense fluorescence is desired.
Exemplary Composition Forming Methods
According to one exemplary embodiment, the present edible ink can be made by performing the following steps: First, an aqueous acid or buffer solution is prepared. Colorant is then added to the acid solution and mixed. Next, a surfactant is added to the solution. Finally, the solution is mixed until the colorant is well dissolved. In another exemplary embodiment, the ink can be formed by performing the following steps: First, the ink vehicle is prepared by combining and mixing a solvent, surfactant, and humectant. The colorant is then added and mixed until dissolved.
Exemplary Implementation and Operation
Once formed, the present edible ink may be dispensed onto a pharmaceutical product or other substrate to form a desired image that is invisible to the naked eye under normal white light conditions but visibly fluoresces and exhibits a distinct fluorescent emission profile when exposed to UV light.
As shown in
Once the pharmaceutical product is positioned under the desired ink dispenser (650), the ink dispenser is directed to selectively deposit the above-mentioned ink onto the pharmaceutical (step 510;
As an image is printed on a pharmaceutical product, the computing device (610) may controllably position the moveable substrate (680) and direct one or more of the ink dispensers (650) to selectively dispense an edible ink at predetermined locations on the pharmaceutical product (670) as digitally addressed drops, thereby forming the desired image. The ink material dispensers (650) used by the present printing system (600) may be any type of ink dispenser configured to perform the present method including, but in no way limited to, thermally actuated inkjet dispensers, mechanically actuated inkjet dispensers, electrostatically actuated inkjet dispensers, magnetically actuated dispensers, piezoelectrically actuated dispensers, continuous inkjet dispensers, etc. Additionally, the ink-jet material dispenser can be heated to assist in dispensing the edible ink. Moreover, the present edible ink can be distributed using any number of printing processes including, but in no way limited to, inkjet printing, lithography, screen printing, gravure, flexo printing, or stamping.
Once the desired image or pattern is formed on the pharmaceutical product (670), the ink dries (step 520;
After the jetted image is inspected (step 530;
Once the initial inspection process (step 540;
Marking pharmaceutical solid dosage forms with a spectral fingerprint of fluorescent compounds will help track fraudulent dispensing of drugs, protect drugs from counterfeiting, and ensure that patients receive the right medication without affecting the product's appearance.
In an alternative embodiment, the present edible invisible ink may be used to mark a urethane polymer covering or other pharmaceutical packaging of a pharmaceutical. Pharmaceuticals are often packaged in a urethane polymer covering referred to as a blister coating. Similar to the restrictions placed on pharmaceuticals, the FDA restricts the colorants that may be used to mark pharmaceutical packaging. According to one exemplary embodiment, the present system and method is used to mark a urethane polymer covering or other pharmaceutical covering with an edible ink. According to this embodiment, a product name, dosage, barcode, or any other marking may be printed on the urethane polymer coating using the methods explained above. Once printed, the edible ink will not obstruct the view of a contained pharmaceutical or otherwise deface the urethane polymer covering when viewed under normal white light conditions. However, when exposed to UV light, the edible ink fluoresces in the visible light range exposing a spectral fingerprint.
In yet an additional alternative embodiment, the above-mentioned systems and methods may be used to mark and/or track any number of substrates. According to this exemplary embodiment, any number of UV fluorescing inks having distinct fluorescent emission profiles may be used for industrial applications. More specifically, inks having known fluorescent emission profiles may be applied to any substrate including, but not limited to, packaging. According to this exemplary embodiment, the UV fluorescing inks may include non-edible inks for a number of non-oral applications. Consequently, the UV fluorescing inks may be dispensed onto the desired substrate in any number of formations.
In conclusion, the present system and method for implementing an edible ink provide a way to mark pharmaceuticals with “invisible” unique marks to control fraudulent dispensing of counterfeit drugs and to aid in the dispensing and administration of drugs, while reducing medication errors. Such inks are designed for a unique spectral profile when excited with illumination of a known wavelength. The use of multiple inks in combined patterns to authenticate pharmaceutical products is difficult to duplicate. In addition, data can be encoded within these patterns to enable product tracking features. The present edible ink may be safely used to print or otherwise mark on pharmaceutical substrates such as tablets, capsules, gel caps, pills, caplets, and other solid dosage forms; dental products and instruments; and or food products.
Products may be marked by the present edible ink with information such as, but not limited to, logos, names, bar codes, alphanumeric codes, text, watermarks, and other markings. Marking pharmaceuticals with information using invisible ink allows manufacturers and distributors to control fraudulent dispensing of drugs, control counterfeit production of drugs, and ensure that patients receive the correct medication, among other things.
The preceding description has been presented only to illustrate and describe embodiments of the invention. It is not intended to be exhaustive or to limit the invention to any precise form disclosed. Many modifications and variations are possible in light of the above teaching.