WO2025038541A1

WO2025038541A1 - Secondary label for a prescription medication, pharmaceutical container for a prescription medication, and method for labeling a pharmaceutical container

Info

Publication number: WO2025038541A1
Application number: PCT/US2024/041916
Authority: WO
Inventors: Eric Rosendall
Original assignee: WestRock MWV LLC
Current assignee: WestRock MWV LLC
Priority date: 2023-08-11
Filing date: 2024-08-12
Publication date: 2025-02-20
Anticipated expiration: 2026-02-11
Also published as: MX2025007309A

Abstract

A secondary label for a prescription medication, includes: a transparent layer; a thermally printable white layer, wherein a first portion of the thermally printable white layer is permanently attached to a first portion of the transparent layer to define a hinged portion; and a permanent adhesive on the transparent layer opposite the thermally printable white layer.

Description

SECONDARY LABEL FOR A PRES CRIPTION MEDICATION, PHARMA CEUTICAL CONTAINER FOR A PRES CRIPTION MEDICATION, AND METHOD FOR LABELING A PHARMA CEUTICAL CONTAINER

FIELD

[0001] The present application relates to the field of labels for pharmaceutical containers, and pharmaceutical containers comprising such labels.

B AC KG R O UN D

[0002] Prescription medications are essential tools in managing a wide range of health conditions. Appropriate use of these medications relies heavily on clear and accessible information about the prescribed drug. This information is typically conveyed through labels affixed to the medication's container. The labels may include details such as the medication's name, the prescribed dosage, the patient's name, and instructions for use. However, traditional labeling methods can present challenges in terms of visibility and accessibility of this information.

[0003] Pharmaceutical labels are typically small due to the limited space available on medication containers. This often results in small font sizes that can be difficult for many patients to read, particularly those with vision impairments or the elderly. Additionally, these labels are often handled frequently and may be exposed to various environmental factors, such as heat, moisture, or chemicals, that can degrade the label over time. This may lead to fading or smudging of the printed information, further impacting its readability.

[0004] Some medications come with additional information or instructions that cannot fit on the primary label. This extra information is usually provided on secondary labels, which can be easily overlooked or lost by the patient. Furthermore, these secondary labels often replicate the same design issues as primary labels, including small font sizes and susceptibility to environmental damage. [0005] Thus, there is a need for a more effective pharmaceutical labeling system that enhances the visibility and accessibility of medication information, is durable and resistant to environmental damage, and is compatible with efficient and high-quality printing methods such as thermal printing. The present description addresses these challenges by providing a secondary label for prescription medications that meets these criteria.

S U MM ARY

[0006] In the following summary, exemplary features of the described secondary label for a prescription medication and the pharmaceutical container and the method incorporating the same are presented.

[0007] In an example, a secondary label for a prescription medication, comprises: a transparent layer; a thermally printable white layer, wherein a first portion of the thermally printable white layer is permanently attached to a first portion of the transparent layer to define a hinged portion; and a permanent adhesive on the transparent layer opposite the thermally printable white layer.

[0008] In an aspect, the transparent layer comprises a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear’ polycarbonate (PC), and clear’ polyvinyl chloride (PVC). In an aspect, the transparent layer comprises clear biaxially oriented polypropylene (BOPP). In an aspect, the transparent layer has a thickness in a range of 1 mil to 3 mil, preferably 1.5 mil to 2.5 mil, more preferably 1.75 mil to 2.25 mil, with a most preferable thickness of 1 .85 mil. In an aspect, the first portion of the thermally printable white layer is permanently attached to the first portion of the transparent layer through at least one of heat lamination, adhesive bonding, ultrasonic welding, and solvent bonding. In an aspect, the permanent adhesive comprises at least one of a vinyl adhesive, an acrylic adhesive, a rubberbased adhesive, and a silicone-based adhesive.

[0009] In an aspect, the thermally printable white layer comprises: a white sub-layer, wherein a first portion of the white layer is permanently attached to a first portion of the transparent layer to define a hinged portion; and a clear thermally printable sub-layer permanently attached to the white sub-layer opposite the transparent layer. In an aspect, the white sub-layer comprises a white polymer material, such as white polypropylene (PP), white polyethylene terephthalate (PET), white polycarbonate (PC), or white polyvinyl chloride (PVC). In an aspect, the white sublayer comprises white biaxially oriented polypropylene (BOPP). In an aspect, the white sub-layer has a thickness in a range of 0.5 mil to 3 mil, preferably 1 mil to 2.5 mil, more preferably 1.5 mil to 2 mil, with a most preferable thickness of 2.3 mil. In an aspect, the clear thermally printable sub-layer comprises a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), and clear polyvinyl chloride (PVC). In an aspect, the clear thermally printable sub-layer comprises clear biaxially oriented polypropylene (BOPP). In an aspect, the clear thermally printable sub-layer has a thickness in a range of 0.5 mil to 2 mil, preferably 0.75 mil to 1.5 mil, more preferably 0.9 mil to 1.2 mil, with a most preferable thickness of 1 mil. In an aspect, the clear thermally printable sub-layer comprises a thermal- sensitive coating for direct thermal printing. In an aspect, the thermalsensitive coating is colorless and becomes colored when exposed to heat. rooioi In an aspect, the secondary label further comprises a release liner on the permanent adhesive opposite the transparent layer. In an aspect, the release liner comprises at least one of a coated paper liner, a polypropylene (PP) liner, and a polyethylene (PE) liner. In an aspect, the release liner preferably comprises a supercalendered coated paper liner.

[0011] In an aspect, the secondary label further comprising a releasable adhesive on at least one of a second portion of the transparent layer and a second portion of the thermally printable white layer to releasable adhere the transparent layer to the thermally printable white layer. In an aspect, the releasable adhesive comprises a pressure-sensitive adhesive.

[0012] In another example, a method for labeling a pharmaceutical container comprises: providing a pharmaceutical container with a primary label permanently attached to the container body; providing the secondary label as described above; thermally printing information pertaining to the prescription medication onto the thermally printable white layer of the secondary label; and permanently adhering the transparent layer to the primary label. In another aspect, thermally printing the information comprises direct thermal printing.

[0013] In another example, a pharmaceutical container for a prescription medication, comprises: a container body; a primary label permanently attached to the container body; and a secondary label on the primary label, the secondary label comprising: a transparent layer permanently adhered to the primary label; and a thermally printable white layer, wherein a first portion of the thermally printable white layer is permanently attached to a first portion of the transparent layer to define a hinged portion.

[0014] In an aspect, the shape of the container body is cylindrical, rectangular, or square, and the container body is made from plastic, glass, metal, or paper. In an aspect, the primary label comprises: a base layer, made from a durable material like polyester, polyethylene, or paper; an adhesive layer interposed between the base layer and the container body, the adhesive layer facilitating permanent attachment of the base layer to the container body; and a thermally printable coating on the base layer opposite to the adhesive layer. In an aspect, the primary label contains information pertaining to the prescription medication, including but not limited to, patient's name, medication name, dosage instructions, date of issuance, prescribing physician's name, and pharmacy details. In an aspect, the secondary label contains at least a portion of the same information pertaining to the prescription medication as included on the primary label except in a larger font size. In an aspect, the secondary label contains additional information pertaining to the prescription medication, including but not limited to, patient's name, medication name, dosage instructions, date of issuance, prescribing physician's name, and pharmacy details. In an aspect, the pharmaceutical container further comprises a cap attached to the container body, the cap comprising a child-resistant mechanism. In an aspect, the transparent layer comprises a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), and clear polyvinyl chloride (PVC). In an aspect, the transparent layer comprises clear biaxially oriented polypropylene (BOPP). In an aspect, the transparent layer has a thickness in a range of 1 mil to 3 mil, preferably 1.5 mil to 2.5 mil, more preferably 1.75 mil to 2.25 mil, with a most preferable thickness of 1.85 mil. In an aspect, the transparent layer is permanently adhered to the primary label using a permanent adhesive, wherein the permanent adhesive comprises at least one of a vinyl adhesive, an acrylic adhesive, a rubber-based adhesive, and a silicone-based adhesive.

[0015] In an aspect, the thermally printable white layer comprises: a white sub-layer, wherein a first portion of the white layer is permanently attached to a first portion of the transparent layer to define a hinged portion; and a clear thermally printable sub-layer permanently attached to the white sub-layer opposite the transparent layer. In an aspect, the white sub-layer comprises a white polymer material, such as white polypropylene (PP), white polyethylene terephthalate (PET), white polycarbonate (PC), or white polyvinyl chloride (PVC). In an aspect, the white sublayer comprises white biaxially oriented polypropylene (BOPP). In an aspect, the white sublayer has a thickness in a range of 0.5 mil to 3 mil, preferably 1 mil to 2.5 mil, more preferably 1.5 mil to 2 mil, with a most preferable thickness of 2.3 mil. In an aspect, the clear thermally printable sub-layer comprises a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), and clear polyvinyl chloride (PVC). In an aspect, the clear' thermally printable sub-layer comprises clear biaxially oriented polypropylene (BOPP). In an aspect, the clear thermally printable sub-layer has a thickness in a range of 0.5 mil to 2 mil, preferably 0.75 mil to 1.5 mil, more preferably 0.9 mil to 1.2 mil, with a most preferable thickness of 1 mil. In an aspect, the clear thermally printable sub-layer comprises a thermal- sensitive coating for direct thermal printing. In an aspect, the thermalsensitive coating is colorless and becomes colored when exposed to heat.

[0016] In an aspect, the pharmaceutical container further comprises a releasable adhesive on at least one of a second portion of the transparent layer and a second portion of the thermally printable white layer to releasable adhere the transparent layer to the thermally printable white layer. In an aspect, the releasable adhesive comprises a pressure-sensitive adhesive.

[0017] Other embodiments will become apparent from the following detailed description, the accompanying drawings and the appended claims.

B R IEF D ES CRIPTIO N O F THE D RAW IN G S

[0018] FIG. 1 is a perspective view of a pharmaceutical container with a container body, a cap, a primary label, and an exemplary secondary label according to a first embodiment. The secondary label comprises a transparent layer and a thermally printable white layer. The transparent layer and a portion of the white layer form a hinge for the secondary label.

[0019] FIG. 2 is a cross-sectional view of the pharmaceutical container along section line 2-2 from FIG. 1. This view details the layers of the primary and secondary labels. The primary label is attached to the container body with an adhesive layer (not shown). The secondary label is comprised of the transparent layer and the thermally printable white layer. The thermally printable white layer is further divided into a white sub-layer and a clear thermally printable sublayer. The transparent layer and part of the white layer form a hinged structure.

[0020] FIG. 3 is a plan view of an exemplary secondary label according to a second embodiment.

[0021] FIG. 4 is a cross-sectional view of the exemplary secondary label of FIG. 3.

D ETA ILED D E S C R IP TIO N

[0022] In the following detailed description, for purposes of explanation and not limitation, representative examples disclosing specific details are set forth in order to provide a thorough understanding of the present teachings. However, it will be apparent to one having ordinary skill in the ail having had the benefit of the present disclosure that other examples that depart from the specific details disclosed herein remain within the scope of the appended claims. Moreover, descriptions of well-known devices and methods may be omitted so as to not obscure the description of the example embodiments. Such methods and devices are clearly within the scope of the present teachings.

[0023] The description that follows is presented to enable any person skilled in the art to make and use the disclosed embodiments, and is provided in the context of a particular application and its requirements. Various modifications to the disclosed embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments and applications without departing from the scope of those that are disclosed.

Thus, the present description is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features that are disclosed herein.

[0024] The present description relates to a secondary label for a prescription medication, which offers an enhanced labeling system that provides better visibility and accessibility of information related to the prescription medication.

[0025] The secondary label comprises a transparent layer, a printable (e.g., thermally printable) white layer, and a permanent adhesive on the transparent layer opposite the thermally printable white layer. This structure allows for the creation of a hinged portion by permanently attaching a first portion of the printable white layer to a first portion of the transparent layer. The secondary label is described with reference to a thermally printable white layer, particularly a direct thermally printable white layer. However, other types of printing may be employed.

[0026] The first portion of the thermally printable white layer may be permanently attached to the first portion of the transparent layer through various methods, including but not limited to, heat lamination, adhesive bonding, ultrasonic welding, and solvent bonding.

[0027] The transparent layer may be comprised of a clear polymer material, which may be, but is not limited to, clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), or clear polyvinyl chloride (PVC). This layer could have a thickness ranging from 1 mil to 3 mil, though it's preferably in the range of 1.5 mil to 2.5 mil, more preferably 1.75 mil to 2.25 mil, and most preferably about 1.85 mil.

[0028] In an example, the transparent layer is clear biaxially oriented polypropylene (BOPP). Biaxially Oriented Polypropylene (BOPP) is polypropylene film that has been stretched in both the machine and cross directions. This stretching process aligns the polymer molecules in two directions, enhancing its strength and clarity. BOPP offers several advantages that make it an excellent choice for the transparent layer. Firstly, BOPP possesses superior tensile strength, making it highly durable and resistant to tearing and damage. This may be advantageous in a context such as a pharmacy where labels must withstand handling and potentially harsh storage conditions. Secondly, BOPP is highly resistant to chemicals, moisture, and abrasion, ensuring the label's longevity and the preservation of the printed information against environmental factors. Thirdly, clear BOPP has excellent clarity and gloss, making it ideal for applications where visibility through the material is desirable. In this case, the clear BOPP allows for easy viewing of the information printed on the thermally printable white layer of the secondary label. Lastly, BOPP films are compatible with a variety of ink and adhesive systems, making them versatile for different printing and bonding techniques. It is also resistant to thermal deformation, making it suitable for thermally printed labels.

[0029] The permanent adhesive applied on the transparent layer, which is opposite the thermally printable white layer, can include, for example, at least one of a vinyl adhesive, an acrylic adhesive, a rubber-based adhesive, and a silicone-based adhesive. [0030] In an example, the thermally printable white layer may be composed of a white sublayer and a clear thermally printable sub-layer. The first portion of the white layer may be permanently attached to a first portion of the transparent layer to define a hinged portion. On the opposite side of the white sub-layer from the transparent layer, there is a clear thermally printable sub-layer permanently attached to it. The clear thermally printable sub-layer may be permanently attached to the white sub-layer using a permanent adhesive applied on one or both of the clear thermally printable sub-layer and the white sub-layer. The permanent adhesive can include, for example, at least one of a vinyl adhesive, an acrylic adhesive, a rubber-based adhesive, and a silicone-based adhesive.

[0031] The white sub-layer may be made of white polymer material, which can be, but is not limited to, white polypropylene (PP), white polyethylene terephthalate (PET), white polycarbonate (PC), or white polyvinyl chloride (PVC). In an example, it can be made of white biaxially oriented polypropylene (BOPP), some advantages of which are described above. The white sub-layer has a thickness ranging between 0.5 mil to 3 mil, though it's preferably in the range of 1 mil to 2.5 mil, more preferably 1.5 mil to 2 mil, and most preferably about 2.3 mil. By the term white, it is intended to mean any light color or shade that provides a high contrast against the thermal printing. The purpose is to provide a sufficiently distinct and readable background for the printed information, regardless of the exact color. In addition, the term could also encompass various finishes that contribute to contrast, such as matte or glossy, depending on the specific requirements of the thermal printing process and the readability of the printed information.

[0032] The clear thermally printable sub-layer can be a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), or clear polyvinyl chloride (PVC), or clear biaxially oriented polypropylene (BOPP), some advantages of which are described above.. It has a thickness ranging from 0.5 mil to 2 mil, but preferably 0.75 mil to 1.5 mil, more preferably 0.9 mil to 1.2 mil, with a most preferable thickness of 1 mil. This sub-layer may include a thermal-sensitive coating for direct thermal printing, which is colorless and becomes colored when exposed to heat. [0033] This example demonstrates an effective combination of two layers to create the thermally printable white layer, each fulfilling different functions to achieve the desired properties of the secondary label. The white sub-layer provides a bright, high-contrast background that enhances the visibility of the printed information. Given the mentioned properties, this layer might also provide structural support to the secondary label. The use of a white polymer material such as white polypropylene (PP), white polyethylene terephthalate (PET), white polycarbonate (PC), or white polyvinyl chloride (PVC) ensures durability, flexibility, and excellent printability. The clear thermally printable sub-layer, on the other hand, is designed to respond to thermal printing. This layer may include a thermal-sensitive coating that changes color when heated, allowing information to be printed directly onto it. This sublayer, being clear, also maintains the visibility of the printed information and the white sub-layer beneath it. The two sub-layers are permanently attached to each other using a permanent adhesive, such as a vinyl adhesive, an acrylic adhesive, a rubber-based adhesive, or a silicone- based adhesive. This adhesive secures the layers together and ensures the integrated functionality of the thermally printable white layer. This combination of the white sub-layer and clear thermally printable sub-layer takes advantage of the distinct properties of each, thereby optimizing the functionality of the thermally printable white layer. It's a viable approach because it effectively provides a durable, high-contrast, and thermally responsive surface for printing, all advantageous features for the secondary label.

[0034] The secondary label may further include a release liner on the permanent adhesive, opposite the transparent layer. The release liner may be made from, for example, a coated paper liner, a polypropylene (PP) liner, or a polyethylene (PE) liner. In the example, the release liner is a supercalendered coated paper liner.

[0035] Further, a releasable adhesive may be present on either the second portion of the transparent layer or the second portion of the thermally printable white layer. This adhesive is designed to allow the transparent layer to be releasably adhered to the thermally printable white layer. This releasable adhesive could be a pressure-sensitive adhesive, which enables removal of the label to allow access to the underlying primary label without leaving a residue. [0036] Thermal printing can offer several advantages for pharmaceutical labels, including the secondary label system described. Thermal printing is a faster process compared to many other printing technologies, which can increase the efficiency of label production. This speed can be especially valuable in pharmaceutical settings, where large volumes of labels may need to be produced quickly. Thermal printers can produce high-resolution images and texts, making them ideal for printing small, detailed information that is often required on pharmaceutical labels. This can contribute to improved readability and accessibility of the information on the label. Thermal printing creates labels that are resistant to heat, moisture, sunlight, and friction, enhancing their longevity. This is crucial for pharmaceutical labels, which must remain legible and intact for extended periods and may be exposed to a variety of environmental conditions. Thermal printers are excellent for variable data printing - a process where each label has some unique element (like a unique ID, serial number, or patient- specific information). This is often a requirement in pharmaceutical applications for tracking and traceability purposes. The lack of ink in thermal printing can reduce the potential for smudging or errors in printing. This could enhance the accuracy of the printed information, which is critical when it comes to pharmaceuticals. Thermal printers can be more cost-effective over the long term because they do not require ink, toner, or ribbons to operate. This can lead to lower running costs and fewer supply chain considerations. With no need for ink or toner, thermal printing is often seen as a more environmentally friendly choice. In industries like pharmaceuticals where sustainability is becoming more and more important, this could be a significant benefit. By integrating a thermally printable white layer into the secondary label design, pharmaceutical manufacturers could benefit from these advantages, leading to improved functionality and performance of their medication labels.

[0037] The description also encompasses a method for labeling a pharmaceutical container using the above-mentioned secondary label. The method includes providing a pharmaceutical container with a primary label permanently attached to the container body, providing the secondary label as described above, and thermally printing information pertaining to the prescription medication onto the thermally printable white layer of the secondary label. This information may be printed using, for example, direct thermal printing. After printing, the method includes permanently adhering the transparent layer of the secondary label to the primary label. [0038] Another aspect of this description encompasses a pharmaceutical container for prescription medication. This container includes a container body, a primary label permanently affixed to the container body, and a previously discussed secondary label attached onto the primary label. The container body can be conceived in a wide variety of shapes and forms based on the specific requirements of the medication and user preferences. In terms of shape, the container body can take multiple forms ranging from cylindrical to rectangular, square, or even custom shapes. It could take on the conventional pill bottle shape, or adopt a more advanced structure with multiple components. The exact design could be oriented towards user convenience, safety, or specific medication needs such as pill size, dosage frequency, or storage conditions. As for the material, the container body can be manufactured from a broad range of suitable substances including, but not limited to, plastic, glass, metal, paper or other recyclable materials. Plastic and glass have been traditionally used for their durability and ability to create airtight, secure containers. Paper or other recyclable materials could be used to create outer cartons or secondary packaging, contributing to environmental sustainability.

[0039] The primary label includes a base layer, which may be made from a durable material like polyester, polyethylene, or paper. An adhesive layer is interposed between the base layer and the container body to facilitate permanent attachment. This base layer may also feature a thermally printable coating on the side opposite the adhesive layer.

[0040] The primary label typically contains patient- specific information relating to the prescription medication, such as the patient's name, medication name, dosage instructions, date of issuance, prescribing physician's name, and pharmacy details. The secondary label can contain at least a portion of the same information as the primary label, but in a larger font size for better visibility. It could also contain additional patient- specific information or different information.

[0041] Additionally, the pharmaceutical container may comprise a cap attached to the container body, which includes a child-resistant mechanism.

[0042] All components of the pharmaceutical container, including the transparent layer, the thermally printable white layer, and their respective sub-layers, can be constructed of the materials and have thicknesses as previously described for the secondary label. [0043] By providing the transparent layer and thermally printable white layer, the present description offers an improved labeling system that maximizes information visibility and accessibility on prescription medication containers, enhancing patient safety and convenience.

[0044] The described secondary label offers dual benefits that significantly enhance the user experience and overall safety for all patients, particularly for those who are visually impaired.

[0045] Enhanced Access to Primary Label Information: With the inclusion of a transparent layer in the secondary label, the information presented on the primary label remains visible and accessible even after the secondary label is affixed. This is important, as it ensures that critical information about the medication (such as the patient's name, medication name, dosage instructions, date of issuance, prescribing physician's name, and pharmacy details) isn't obscured.

[0046] Additional Information on the Secondary Label: The thermally printable white layer on the secondary label provides an additional space for relaying important medication information. This could serve to either replicate some or all of the primary label content in a larger font size, or present additional instructions or data that couldn't be accommodated on the primary label due to size constraints.

[0047] For visually-impaired patients who might straggle to read the small print typically found on primary medication labels, this dual-layer system is particularly beneficial. The ability to print in larger font sizes on the secondary label could greatly enhance legibility for those with reduced vision. This contributes significantly to patient safety by reducing the likelihood of medication errors and ensuring that patients are well-informed about their prescribed treatment.

[0048] This described secondary label system, with its transparent and thermally printable layers, offers a comprehensive solution to enhance information visibility and accessibility on pharmaceutical containers. By maintaining the visibility of the primary label while offering additional, potentially larger-print information on the secondary label, this system helps ensure that patients, including those with visual impairments, have easy access to the information they need for safe and effective medication use.

[0049] The pharmaceutical container also includes a permanent adhesive to secure the secondary label to the primary label, providing a reliable and stable application of the secondary label. The adhesive can comprise at least one of a vinyl adhesive, an acrylic adhesive, a rubberbased adhesive, and a siliconc-bascd adhesive.

[0050] The thermally printable white layer of the secondary label on the pharmaceutical container comprises a white sub-layer and a clear thermally printable sub-layer. Both of these sub-layers are permanently attached to one another and can comprise materials as previously discussed in the context of the secondary label. These may include white or clear polypropylene (PP), polyethylene terephthalate (PET), polycarbonate (PC), polyvinyl chloride (PVC), or biaxially oriented polypropylene (BOPP), some advantages of which are described above.

[0051] The white sub-layer typically has a thickness in a range from 0.5 mil to 3 mil, preferably 1 mil to 2.5 mil, more preferably 1.5 mil to 2 mil, and most preferably 2.3 mil. The clear thermally printable sub-layer has a thickness ranging from 0.5 mil to 2 mil, preferably 0.75 mil to 1.5 mil, more preferably 0.9 mil to 1.2 mil, and most preferably 1 mil.

[0052] In the pharmaceutical container, the clear' thermally printable sub-layer features a thermal- sensitive coating for direct thermal printing. This coating is colorless under normal conditions and becomes colored when exposed to heat, thus facilitating thermal printing.

[0053] The secondary label on the pharmaceutical container may also include a releasable adhesive on at least one of a second portion of the transparent layer and a second portion of the thermally printable white layer, allowing the transparent layer to be releasably adhered to the thermally printable white layer. The releasable adhesive may comprise a pressure-sensitive adhesive.

[0054] Referring to FIG. 1, a pharmaceutical container (100) is shown. The container (100) comprises a container body (110) and a cap (120). The container body (110) is designed to hold the prescribed medication. It may be of any shape suitable for the particular' medication it contains, such as cylindrical, rectangular, or square, and made from any suitable material, including but not limited to plastic, glass, metal, or paper. The cap (120) is designed to securely seal the container body (110) to maintain the medication's integrity. The cap (120) can include a child-resistant mechanism to prevent access to the medication by children, offering an additional layer of safety. [0055] A primary label (130) is permanently attached to the container body (110). This primary label (130) typically contains essential information related to the prescription medication, such as the patient's name, the medication name, dosage instructions, date of issuance, prescribing physician's name, and pharmacy details.

[0056] The secondary label (140) as described herein is affixed onto the primary label (130). The secondary label (140) comprises a transparent layer (150) and a thermally printable white layer (160).

[0057] The transparent layer (150) is comprised of a clear polymer material, such as clear BOPP, which provides excellent durability, clarity, and resistance to environmental factors. This layer is permanently adhered to a portion of the thermally printable white layer (160), forming a hinged portion of the secondary label (140).

[0058] The thermally printable white layer (160) is designed for printing information about the medication. This layer may be made up of a white sub-layer and a clear thermally printable sublayer (not shown in FIG. 1). The white sub-layer provides a high-contrast background to enhance the visibility of printed information. The clear thermally printable sub-layer, on the other hand, is designed to respond to thermal printing, thereby providing a durable and heat-responsive surface for printing.

[0059] The secondary label (140) can contain the same information as the primary label (130), but in a larger font size for better visibility. It may also contain additional patient- specific information or different information. Its design provides easy access to the underlying primary label (130) while maintaining the integrity and readability of its own printed information.

[0060] This design as shown in FIG. 1 thus demonstrates an efficient, readable, and durable labeling system for pharmaceutical containers that enhances the visibility and accessibility of crucial medication-related information.

[0061] Turning now to FIG. 2, a cross-sectional view of the container (100), as shown along section line 2-2 of FIG. 1, with the primary (130) and secondary labels (140) is depicted. Starting from the innermost pail, the container body (110) is present, typically made from materials such as plastic, glass, or metal suitable for storing the specific medication. [0062] Attached to the container body (110) is the primary label (130). The primary label includes a base layer, which could be made of a durable material like polyester, polyethylene, or paper. This base layer is permanently attached to the container body (110) through an adhesive layer (not shown in FIG. 2). This base layer may also include a thermally printable coating on the side opposite to the adhesive layer, allowing for the printing of essential medication information.

[0063] Over the primary label (130) is the secondary label (140) comprised of a transparent layer (150) and a thermally printable white layer (160). The transparent layer (150) is made of a clear polymer material like clear BOPP. It is bonded to a portion of the thermally printable white layer (160) forming a hinged structure (152).

[0064] The thermally printable white layer (160) is made of a white sub-layer (162) and a clear thermally printable sub-layer (164). These sub-layers are permanently attached to each other, with the clear thermally printable sub-layer facing outwards to receive the thermal printing. The white sub-layer (162) provides a high-contrast background for the printed information, while the clear thermally printable sub-layer (164) provides a surface that can react to thermal printing.

[0065] A release liner (not shown in FIG. 2) may have been present on the permanent adhesive, opposite to the transparent layer (150). This liner allows for easy handling and application of the secondary label (140) on the primary label (130).

[0066] Within the realm of pharmaceutical packaging, the clarity, accessibility, ease of application of labeling are desired. Figures 1 and 2 provided an initial insight into a design paradigm, where the labels were tailored for efficiency, readability, and durability, suited for pharmaceutical containers. Transitioning to Figs. 3 and 4, we delve deeper into a refined iteration of the secondary label (140). This advanced design not only enhances the prior features but also introduces additional elements that further augment its performance.

[0067] Turning to FIG. 3, we observe a top view of exemplary secondary label (140) before its application to a pharmaceutical container. This perspective primarily shows the overall shape and layout of the secondary label. A notable feature visible in this view is the hinged area (152). This functional design element allows the secondary label to overlay and yet provide an accessible window to the primary label beneath.

[0068] Moving to FIG. 4, this cross-sectional perspective offers an in-depth look at the multilayered structure of the secondary label. The transparent layer (150) features a release coating (156) that ensures a smooth separation from the thermally printable white layer (160) except for the hinged area (152). The release coating (156) is not applied at the hinged area (152). This is complemented by a clear film (157), which may be crafted from 1.85 mil polypropylene, which guarantees clarity and durability. A pressure-sensitive adhesive layer (158) follows, ensuring that the secondary label adheres firmly to the primary label when applied. The release coating (156) allows the thermally printable white layer (160 to be peeled back to the hinge area (152) and resealed to the thermally printable white layer (160).

[0069] The thermally printable white layer (160) reveals a more detailed design. On its outermost surface lies a thermal reactive coating (165) that's tailored to respond to thermal printing. Beneath this layer is a clear film (164), which may be made from 1.35 mil polypropylene. A subsequent pres sure- sensitive adhesive layer (163) ensures the bond between the clear film and an underlying white film (162). This white film, which may be made from 2.3 mil polypropylene, provides a high-contrast background, ensuring the printed information is easy to read. A foundational adhesive layer (161) is responsible for releasable bonding the entire white layer to the release coating (156) transparent layer (150).

[0070] While Figs. 1 and 2 emphasize the overall assembly and relationship between the primary and secondary labels on a pharmaceutical container, Figs. 3 and 4 shift the focus specifically to the secondary label's architecture. The latter figures give a comprehensive breakdown of an exemplary multilayered design, including components like the release coating (156) and various adhesive layers.

[0071] The detailed description above sets forth exemplary secondary labels for prescription medications and its integration with a primary label on a pharmaceutical container. The secondary label, comprised of a transparent layer and a thermally printable white layer, offers enhanced visibility and accessibility of the medication-related information, thereby potentially improving patient adherence and safety in medication use. [0072] The use of durable and clear materials for the layers ensures the secondary label's longevity and clarity. The inclusion of a thermally printable layer accommodates efficient, high- resolution, and durable printing, enhancing the overall functionality of the label. The inventive design allows for easy removal and repositioning of the secondary label without leaving residue on the primary label, providing user-friendly interaction with the label system.

[0073] In the described method, the secondary label is seamlessly integrated with existing pharmaceutical containers and primary labels, offering a practical and efficient solution to the visibility and accessibility issues of traditional pharmaceutical labels.

[0074] While the detailed description outlines specific embodiments, materials, and methods of assembly, it is understood that variations and modifications can be made without deviating from the scope of the present invention. The described secondary label system and the methods for its use present a significant advancement in the field of pharmaceutical labeling.

[0075] Therefore, the foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

Claims

What is claimed is:

1. A secondary label for a prescription medication, comprising: a transparent layer; a thermally printable white layer, wherein a first portion of the thermally printable white layer is permanently attached to a first portion of the transparent layer to define a hinged portion; and a permanent adhesive on the transparent layer opposite the thermally printable white layer.

2. The secondary label of Claim 1, wherein the transparent layer comprises a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), and clear polyvinyl chloride (PVC).

3. The secondary label of Claim 1, wherein the transparent layer comprises clear biaxially oriented polypropylene (BOPP).

4. The secondary label of Claim 1, wherein the transparent layer has a thickness in a range of 1 mil to 3 mil, preferably 1.5 mil to 2.5 mil, more preferably 1.75 mil to 2.25 mil, with a most preferable thickness of 1.85 mil.

5. The secondary label of Claim 1, wherein the first portion of the thermally printable white layer is permanently attached to the first portion of the transparent layer through at least one of heat lamination, adhesive bonding, ultrasonic welding, and solvent bonding.

6. The secondary label of Claim 1, wherein permanent adhesive comprises at least one of a vinyl adhesive, an acrylic adhesive, a rubber-based adhesive, and a silicone-based adhesive.

7. The secondary label of Claim 1, wherein the thermally printable white layer comprises: a white sub-layer, wherein a first portion of the white layer is permanently attached to a first portion of the transparent layer to define a hinged portion; and a clear thermally printable sub-layer permanently attached to the white sub-layer opposite the transparent layer.

8. The secondary label of Claim 7, wherein the white sub-layer comprises a white polymer material, such as white polypropylene (PP), white polyethylene terephthalate (PET), white polycarbonate (PC), or white polyvinyl chloride (PVC).

9. The secondary label of Claim 7, wherein the white sub-layer comprises white biaxially oriented polypropylene (BOPP).

10. The secondary label of Claim 7, wherein the white sub-layer has a thickness in a range of 0.5 mil to 3 mil, preferably 1 mil to 2.5 mil, more preferably 1.5 mil to 2 mil, with a most preferable thickness of 2.3 mil.

11. The secondary label of Claim 7, wherein the clear thermally printable sub-layer comprises a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), and clear polyvinyl chloride (PVC).

12. The secondary label of Claim 7, wherein the clear thermally printable sub-layer comprises clear biaxially oriented polypropylene (BOPP).

13. The secondary label of Claim 7, wherein the clear thermally printable sub-layer has a thickness in a range of 0.5 mil to 2 mil, preferably 0.75 mil to 1.5 mil, more preferably 0.9 mil to 1.2 mil, with a most preferable thickness of 1 mil.

14. The secondary label of Claim 7, wherein the clear thermally printable sub-layer comprises a thermal- sensitive coating for direct thermal printing.

15. The secondary label of Claim 7, wherein thermal- sensitive coating is colorless and becomes colored when exposed to heat.

16. The secondary label of Claim 1 , further comprising a release liner on the permanent adhesive opposite the transparent layer.

17. The secondary label of Claim 16, wherein the release liner comprises at least one of a coated paper liner, a polypropylene (PP) liner, and a polyethylene (PE) liner.

18. The secondary label of Claim 17, wherein the release liner preferably comprises a supercalendered coated paper liner.

19. The secondary label of Claim 1, further comprising a releasable adhesive on at least one of a second portion of the transparent layer and a second portion of the thermally printable white layer to releasable adhere the transparent layer to the thermally printable white layer.

20. The secondary label of Claim 19, wherein the releasable adhesive comprises a pressuresensitive adhesive.

21. A method for labeling a pharmaceutical container, the method comprising: providing a pharmaceutical container with a primary label permanently attached to the container body; providing the secondary label of claim 1 ; thermally printing information pertaining to the prescription medication onto the thermally printable white layer of the secondary label; and permanently adhering the transparent layer to the primary label.

22. The method of Claim 21, wherein thermally printing the information comprises direct thermal printing.

23. A pharmaceutical container for a prescription medication, comprising: a container body; a primary label permanently attached to the container body; and a secondary label on the primary label, the secondary label comprising: a transparent layer permanently adhered to the primary label; and a thermally printable white layer, wherein a first portion of the thermally printable white layer is permanently attached to a first portion of the transparent layer to define a hinged portion.

24. The pharmaceutical container of Claim 23, wherein the shape of the container body is cylindrical, rectangular, or square, and the container body is made from plastic, glass, metal, or paper.

25. The pharmaceutical container of Claim 23, wherein the primary label comprises: a base layer, made from a durable material like polyester, polyethylene, or paper; an adhesive layer interposed between the base layer and the container body, the adhesive layer facilitating permanent attachment of the base layer to the container body; and a thermally printable coating on the base layer opposite to the adhesive layer.

26. The pharmaceutical container of Claim 23, wherein the primary label contains information pertaining to the prescription medication, including but not limited to, patient's name, medication name, dosage instructions, date of issuance, prescribing physician's name, and pharmacy details.

27. The pharmaceutical container of Claim 26, wherein the secondary label contains at least a portion of the same information pertaining to the prescription medication as included on the primary label except in a larger font size.

28. The pharmaceutical container of Claim 23, wherein the secondary label contains additional information pertaining to the prescription medication, including but not limited to, patient's name, medication name, dosage instructions, date of issuance, prescribing physician's name, and pharmacy details.

29. The pharmaceutical container of Claim 23, further comprising a cap attached to the container body, the cap comprising a child-resistant mechanism.

30. The pharmaceutical container of Claim 23, wherein the transparent layer comprises a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), and clear polyvinyl chloride (PVC).

31. The pharmaceutical container of Claim 23, wherein the transparent layer comprises clear biaxially oriented polypropylene (BOPP).

32. The pharmaceutical container of Claim 23, wherein the transparent layer has a thickness in a range of 1 mil to 3 mil, preferably 1.5 mil to 2.5 mil, more preferably 1.75 mil to 2.25 mil, with a most preferable thickness of 1.85 mil.

33. The pharmaceutical container of Claim 23, wherein the transparent layer is permanently adhered to the primary label using a permanent adhesive, wherein the permanent adhesive comprises at least one of a vinyl adhesive, an acrylic adhesive, a rubber-based adhesive, and a silicone-based adhesive.

34. The pharmaceutical container of Claim 23, wherein the thermally printable white layer comprises: a white sub-layer, wherein a first portion of the white layer is permanently attached to a first portion of the transparent layer to define a hinged portion; and a clear thermally printable sub-layer permanently attached to the white sub-layer opposite the transparent layer.

35. The pharmaceutical container of Claim 34, wherein the white sub-layer comprises a white polymer material, such as white polypropylene (PP), white polyethylene terephthalate (PET), white polycarbonate (PC), or white polyvinyl chloride (PVC).

36. The pharmaceutical container of Claim 34, wherein the white sub-layer comprises white biaxially oriented polypropylene (BOPP).

37. The pharmaceutical container of Claim 34, wherein the white sub-layer has a thickness in a range of 0.5 mil to 3 mil, preferably 1 mil to 2.5 mil, more preferably 1.5 mil to 2 mil, with a most preferable thickness of 2.3 mil.

38. The pharmaceutical container of Claim 34, wherein the clear thermally printable sublayer comprises a clear polymer material, such as clear polypropylene (PP), clear polyethylene terephthalate (PET), clear polycarbonate (PC), and clear polyvinyl chloride (PVC).

39. The pharmaceutical container of Claim 34, wherein the clear thermally printable sublayer comprises clear biaxially oriented polypropylene (BOPP).

40. The pharmaceutical container of Claim 34, wherein the clear thermally printable sublayer has a thickness in a range of 0.5 mil to 2 mil, preferably 0.75 mil to 1.5 mil, more preferably 0.9 mil to 1.2 mil, with a most preferable thickness of 1 mil.

41. The pharmaceutical container of Claim 34, wherein the clear thermally printable sublayer comprises a thermal-sensitive coating for direct thermal printing.

42. The pharmaceutical container of Claim 34, wherein thermal- sensitive coating is colorless and becomes colored when exposed to heat.

43. The pharmaceutical container of Claim 23, further comprising a releasable adhesive on at least one of a second portion of the transparent layer and a second portion of the thermally printable white layer to releasable adhere the transparent layer to the thermally printable white layer.

44. The pharmaceutical container of Claim 43, wherein the releasable adhesive comprises a pressure-sensitive adhesive.