Guardians of Wellness:
Innovations Redefining Safety and Sustainability in Pharmaceutical Packaging
Shashank R Gowda, Ranjitha Venkatesh*, Athmika Sreedhara
Department of Pharmaceutics, R R College of Pharmacy, Chikkabanavara, Bangalore - 560090, India.
*Corresponding Author E-mail: ranjithav.20@gmail.com
ABSTRACT:
Packaging is a crucial task in the pharmaceutical sector. It serves the purpose of protecting and preserving items and communicating marketing and regulatory information to consumers. In the past, packaging requirements only focused on maintaining the quality of enclosed products. Packaging has become a significant factor in the food and drug markets. It must meet criteria such as stability and shelf life, convenience and compliance of product use, prevention of product tampering and counterfeiting, ensuring product safety, and brand identity.
The packaging should have a calming effect on users, complementing the healing properties of the medicine. As the packaging industry continues to evolve, industries are embracing innovations in this field to improve patient adherence to drug regimens. This article discusses the various aspects of pharmaceutical packaging, including the materials used, types of packaging, and recent trends in the pharmaceutical market.
KEYWORDS: Packaging, Patient compliance, Child-resistant, Silenor, Shellpak, NFC tags.
INTRODUCTION:
There is a popular saying that goes, "Don't judge a book by its cover"1. However, it's important to note that the appearance of something initially draws attention. For instance, when customers go shopping, they are typically attracted to stores with an inviting and luxurious interior. This is because they expect the products inside to be of high quality. Similarly, a person's face can reflect their character, ideas, and thoughts. This is why packaging plays a crucial role in marketing products. A well-designed and creative package can often be the deciding factor in whether a product sells or not. For example, even if a product is highly beneficial if wrapped in plain paper and twine, it may not attract buyers.
Therefore, the appearance of a product's packaging is essential to its success in the market.
The packaging of a product is vital as it helps to maintain the quality of the product and build trust with consumers2. Creating an attractive and durable packaging design can be challenging, especially considering the current trend in industrial design where biodegradable or renewable packaging is becoming increasingly popular. Pharmaceutical packaging is made up of various components that protect and enclose the product or materials from production until it is used3. The primary goal of packaging is to ensure the safety and protection of the product during transit until it reaches the hands of the consumer.
Packaging is a cost-effective way of presenting, protecting, and providing information about a product. It serves the purpose of containing, offering convenience, and complying with regulations during storage, transportation, display, and until the product is consumed4. The package must maintain the stability of the product for its entire shelf life. According to the FDA, packaging is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use5.
Pharmaceutical packaging is essential for maintaining the safety and integrity of medicinal products. It helps to prevent contamination and microbial growth and ensures that drugs remain safe throughout their intended shelf life. The main purpose of pharmaceutical packaging is to provide containment, drug safety, identity, and ease of handling and delivery for a wide range of medical products such as surgical devices, blood, and nutraceuticals, as well as various types of dosage forms6.
The packaging of a product is divided into three main categories: primary, secondary, and tertiary packaging7. Primary packaging8 is the first layer of packaging that comes into direct contact with the product and affects its shelf life. Examples of primary packaging include ampoules, vials, prefilled syringes, and other similar items used for parenteral products.
Secondary packaging, on the other hand, is the outer layer of packaging that groups the primary packages. Some examples of secondary packaging include cartons, shipping containers, and boxes9.
Finally, tertiary packaging10 is used for bulk handling and includes items such as barrels and edge protectors.
Pharmaceutical packaging is a major part of the Indian market. In the past, the focus of Pharma packaging was only on maintaining the quality of the enclosed medicine11. But now, the requirements have expanded to include preventing tampering and counterfeiting of products, ensuring accurate product dispensing, and promoting patient compliance with dosage schedules. Like other packaged goods, pharmaceuticals require reliable and fast packaging solutions that provide a combination of product protection, quality, tamper evidence, patient comfort, and security needs12.
The continuous advancements in pharmaceuticals, such as prefilled syringes, blow-fill seal vials, powder applications, and others, also have a direct impact on the packaging.
In the past, the majority of medicines (51%) were taken orally in the form of tablets or capsules, usually packed in blister packs (in Europe and Asia) or pharmaceutical bottles (in the USA). Other oral forms of medications include powders, pastilles, and liquids. However, nowadays other methods of taking medicines are also becoming popular. These methods include inhalation (17%), parenteral or intravenous (29%), and transdermal (3%) methods13.
Nowadays, oral tablets come in various shapes and sizes, which has had a significant impact on the packaging industry. As a result, there is a growing demand for tailored packaging solutions to ensure the effectiveness of medicines. Packaging plays a crucial role in maintaining the efficacy of remedies, as it protects them from environmental factors such as light and humidity, which can cause degradation.
While some packaging innovations provide added benefits in one area, they may not meet the expected standards. For instance, blister packs offer convenience and hygiene but are not always child-resistant14. Advances in packaging machines have led to the inclusion of precise filling mechanisms to prevent the administration of incorrect dosages, which can have life-threatening consequences.
The packaging of medicines should be designed in a way that is easy to open for people aged over 55, as they make up about three-quarters of all medicine users15. At the same time, the industry must ensure that the packaging is child-resistant. The external appearance of the packaging should not only enhance product confidence but also provide clear and concise identification of the product and other features.
The label on the medication packaging should contain all necessary information about the contents, such as legal requirements, the method of administration, the recommended storage conditions, the batch number, the expiry date, the product license number, and the name and address of the manufacturer16.
Additionally, the label should be designed in a way that encourages patients to comply with the instructions for use, and it should ideally be visually appealing.
Based on the application or use of the packaging it is classified as
· Compliance packaging
· Tamper-resistant packaging
· Child-resistant packaging (CR) or Senior friendly packaging (SF)
The pharmaceutical industry provides an excellent platform for the packaging industry to showcase its advanced technology. While packaging serves the purpose of protecting and preserving items, as well as communicating marketing and regulatory information to consumers in most industries, it has the potential to do much more in the pharmaceutical sector. Effective and intelligent packaging can play a crucial role in this industry17.
Smart packaging can benefit both patients and pharmaceutical supply chain management. It can enhance patient compliance, confirm authenticity, support tracking, prevent counterfeiting, and addiction, and protect shelf life.
Clear packaging design is an effective way to achieve this. However, designers of pharmaceutical packaging are increasingly incorporating advancements in printed electronics and internet connectivity to communicate with patients who may have difficulty adhering to their medication schedules19.
This technique aims to enhance communication in the healthcare field. This innovative packaging technology allows patients to communicate with healthcare providers using printed technology while also connecting to the internet20. When a tablet is taken out of its blister pack, this records the time and date it was taken. It also lets patients record and post their comments about the effectiveness of their therapy and any adverse effects. Sensor-based packaging concepts are perhaps best applied in clinical trials, where they aid drug developers in determining whether a drug is ineffective or simply not being taken correctly. This is even though the technology holds great promise for new levels of patient-doctor interface to determine the best and most achievable treatment plan.
Packaging for electronic compliance Cerepak, which MWV created using licensed Cypak technology, is primarily aimed at the clinical trials sector since non-compliance might result in bad results, which can have disastrous financial effects21.
Fig. 1 Cypak's advanced medication monitoring and report card systems.
Catalent's DelPouch Starter Kit (Photo B) encourages patient adherence. With a focus on improving patient involvement and experience, the package is specifically designed to offer convenient and simplified administration, hence enhancing adherence to topical treatments22. Several adherence drivers are included in the kit, including the DelPouch unit-dose delivery system, Media Enhanced Packaging technology from Catalent's connection, and configurations that prompt reminders. It is primarily intended for topical treatments and has some properties that include:
· Design elements that encourage compliance, such as images depicting the day and night treatment regimen.
· More space on billboards for more information.
· Delpouch is a tool that helps users apply topical cream or ointment in the right amount.
· One of the most innovative features of Delpouch is Catalent's Media Enhanced Packaging technology. This enables patients to scan a digitally embedded watermark on the packaging with their smartphones. By doing so, they can access additional product information, videos, and real-time safety updates23.
Figure 2. Ca talent's Delpouch Starter Kit packaging system
Stora Enso has developed the Pharma DDSi24 (Digital Dry Shielding Integration) Wireless packaging system, which is an innovative solution for the pharmaceutical and healthcare industry. The system uses wireless technology to monitor temperature, humidity, and other environmental conditions in real time during the transportation and storage of the products. This ensures that the products remain safe and secure, and allows for prompt action to be taken in case of any issues.
The system comprises a cloud-based platform that manages and analyzes data, offering crucial insights into the supply chain and aiding in the optimization of logistics and inventory management. This advanced mobile technology could have specific applications for patients struggling with Alzheimer's or other neurological disorders, necessitating caregivers and family members to play a more active role in their treatment.
The package incorporates conductive ink on a carton board-based blister inlay, which is connected to a cellular module. This system enables the tracking of each pill as it is removed from the blister, and the data is sent to the cellular module. The information is then forwarded wirelessly, even instantaneously if needed, using GSM or GPRS cellular networks to electronic health record systems. This allows real-time tracking and intervention by a physician, enabling timely changes to be made to a patient's medication.
The blister inlay that connects to the cellular module in the Pharma DDSi Wireless is made of eco-friendly, recyclable carton board and does not contain any metal components25. Additionally, the cellular module is equipped with a rechargeable battery that can last for several months without the need for recharging.
Automated real-time reminders help to improve the control of prescribed medication. This solution provides healthcare service providers with various benefits, including the ability to send voice-call reminders or text messages (SMS) to patients or make personal visits when important prescribed medication has not been taken on time.
Patients can also choose to share their data with relatives, pharmacists, physicians, and healthcare providers, enabling them to treat the patient more effectively and intervene if treatment changes are required.
Figure 3: Stora Enso - Pharma DDSi Wireless System
The Shellpak packaging26 system is an innovative and secure solution for storing and dispensing pharmaceutical products. It is tamper-proof, patient-friendly, and an eco-friendly alternative to traditional blister packs. This reusable and lightweight packaging system aims to help improve medication adherence and reduce waste. By using minimal packaging materials, it is also designed to lower the environmental impact.
To help patients keep track of their medication schedule, the tablets are arranged in a color-coded format according to the days and weeks. Additionally, the pack comes with reminders to refill the prescription. The 30-day blister pack is enclosed in the 170mm Shellpak, which is a patented child-resistant package design.
Figure 4: Shellpack packaging system
The tough plastic design features a front and back label. The back label provides a designated area for the patient's prescription label, along with an attached prescription insert. On the front of the pack, there is an extended content booklet label that includes a photograph of the pill.
The front label of the medication includes several pages that provide patients with helpful information such as dosing instructions, guides to join the BP Success Zone Program, regulatory information, and contact details for further assistance27. The easy-open button makes it easy to use the medication, while the pre-packaged blister ensures pharmacy accuracy and efficiency.
The calendar on the back of the blister helps patients keep track of their dosing and refill schedule. Additionally, the standardized format can be used for multiple medications and SKUs.
The secure, tear-resistant carton simplifies pill expression and doesn't require paper backing on the foil blister, ensuring the highest level of child resistance. The spine labels clearly distinguish drugs and strengths in the pharmacy and home. Lastly, the recyclable outer carton promotes environmental responsibility.
This type of packaging generally consists of informative resources that aid patients in initiating and regulating their treatment with Silenor - a prescription drug utilized for treating insomnia. These starter kits typically entail crucial details about the medication, such as instructions for dosing, potential side effects, safety information, and materials that may help track their treatment progress.
The new carton design is quite innovative, as it opens up to reveal a bedroom-like compartment with a bed and nightstand. The design contains a seven-count unit dose carded blister that can be conveniently removed for portability. The carton design also includes a literature pocket that houses the medication guide, the Sleep-Saver Program prescription discount card, and a multi-panel color leaflet with instructions on taking Silenor. This leaflet also includes information on side effects, guidelines for enrolling in the Sleep-Saver program (including the website and toll-free number), as well as additional information on insomnia treatment. This design aims to support patient compliance and adherence28.
Figure 5: Silenor patient starter kit
According to the Freedonia report, AmerisourceBergen's CIAB (Compliance in a Bottle) is one of the most innovative unit-dose plastic bottles available on the market. This bottle has an internal calendar blister pack that dispenses individual doses one at a time29. Combining the durability and convenience of a plastic bottle with the compliance prompting features of a unit dose blister, it helps patients take their medication correctly. Moreover, compared to a traditional bottle, it provides more space for patient education and branding.
Figure 6: CIAB packaging system
The package is both highly portable and extremely sturdy, making it convenient to take along on a daily or long-term basis. The broad surfaces offer excellent branding opportunities as well as labeling options. The customization options available for the bottle color, size, and label design add to the brand distinction. To open the package, consumers can simply push down and slide the cap. Removing the blister card is also easy for dispensing. Since the package provides child resistance, the burst strength required to compromise the pill cavity is minimized, making it more senior-friendly30.
Child-resistant (CR) packaging is an essential packaging intended to reduce the risk of children taking drugs or dangerous items. This child-resistant packaging decreases children's access to the items by making it difficult for them to open, while also ensuring that adults can easily open and seal the packaging. According to WHO reports, acute poisoning causes around 3000 unintentional deaths in young children annually, most of which occur at home. A common cause of non-fatal poisoning in children is ingestion of adult medication that belongs to their parents or grandparents31.
The World Health Organization and study have noted a considerable decline in unintentional child poisoning with the introduction of child-resistant packaging. CR packaging has been very advantageous for the pharmaceutical industry, and medications are now packaged in child-resistant packaging by national regulations32.
Figure 7: Blister packaging
Blister packaging is commonly utilized in the pharmaceutical industry since it is an effective way to meet child-resistant criteria. These blister packs are inexpensive and provide reasonable protection. Children find it difficult to open these packages because of the multiple layers of backing made of aluminum, cold-form foil, PVC (polyvinyl chloride), etc. However, adults can easily open the blister packaging by pushing the pills or capsules across the back layers of the packaging or by removing the back layer of packaging from designated locations33.
Along with senior-friendly features, the Burgopak CR Slider pack maintains the original Burgopak design's engaging operating system. The patient must pull the end tab and press two buttons—one on each side of the pack—to open the Burgopak CR Slider pack. When the pack opens, the blister is visible on one side, contained in a plastic tray, and the patient information is visible on the other, organized into an easily readable booklet. The patient just needs to insert the end tab back into the pack to reengage the CR lock once they have accessed the medication34. Because the pack itself is CR, there is no need for stronger CR blister foils, making it easier to use for seniors and people with limited dexterity. Formats for calendar blisters can also be utilized to improve adherence.
Figure 8: Burgopak's sliding CR blister pack
The Pharma Pack Paris show's Most Innovative Child Resistant Packaging Design award went to Burgopak Healthcare & Technology. F=1 for senior-friendly efficacy and child resistance from the Consumer Product and Safety Commission. The pack maintains the blister, patient data, and outer carton attached at all times, which promotes compliance. It also makes the pack small and lightweight35.
SHR is a recloseable container that is safe for children. It is appropriate for medications with significant toxicity.
Pharma tiny hands resistance was introduced by Bosch and Stora Enso (SHR). People will find it more difficult to remove the medication if they are not supposed to since it is made to be recloseable and resistant to tearing or cutting. This may lessen the chance of mishaps or illegal drug availability. While challenging for unauthorized people to access, the SHR container is designed to be simple to open for medical professionals who possess the required training and rights36.
Child-resistant closures and caps are made with sophisticated designs that are simple to operate and have long-lasting safety components. These caps and closures include locking mechanisms that need a certain skill to open, making it challenging for kids to open. Three well-known methods must be used by the user to unlock the cap: pressing the cap while turning, twisting, and raising the lid all at the same time37.
Figure 9: Child-resistant (CR) closures and caps
These days, there is ongoing demand in the packaging industry to provide sustainable and environmentally friendly goods. One of the most intricate areas of the industry, pharmaceutical packaging, is now being impacted by this. The fact that environmental factors cannot in any way compromise a package's accessibility or safety is a significant barrier when creating sustainable packaging38.
Ecoslide-RX is a sustainable compliance package that was introduced by Keystone Folding Box Company in collaboration with Legacy Pharmaceutical Packaging. There is very little foil and film that is not feasible in this pack, which is made entirely of recycled materials. Because heat sealing is no longer required during the manufacturing process, it also lowers expenses and energy consumption39.
This kind of secondary package isn't constructed of plastic. It has a long-lasting design because all of the materials are recyclable. It requires the least quantity of film and foil when compared to other paperboard compliance packs. As demonstrated by bottling lines, it is cheap and highly automated.
Figure 10: Ecoslide-RX
The locking system of the Ecoslide-RX may be unlocked by pressing a release button on the corner of the carton with the thumb. This process ensures both outstanding anti-child and anti-aging properties. There is a foil or film that serves as a push-through blister card within the outer carton. Once the CR lock is removed, it slides out and remains affixed to the carton the entire time. It is not necessary to heat seal the paperboard during the assessment process. The carton can be opened according to the directions. To open the pack, customers only need to slightly press a release button. Furthermore, the pack simplifies pill access compared to the traditional push-through technique40.
"Ready-to-use" syringes are becoming more and more popular among medical professionals as a safe and effective way to provide exact dosages of medications. Pre-sterilized syringes are sent straight to the filling and packaging department in sealed plastic tubs, obviating the cleaning and heat sterilizing requirement.
Figure 11: Prefilled syringes
Pre-sterilized, ready-to-fill syringes are becoming more widely available, which has increased their market share in comparison to bulk syringes that require processing before filling. When prefilled syringes became available, self-administered medication could now be delivered accurately and conveniently41.
The innovative pre-filled syringe Syreen was created at Cambridge Consultants. Syreen is a medication delivery system that is exceptionally efficient, secure, and simple to use for self-administration42.
Figure 12: Syreen prefilled syringe
Syreen syringes are manufactured of COP (cyclic olefin polymer) plastic rather than glass, eliminating the need for additional packaging. Syringes nest in a pack thanks to the construction of the Syreen, and the COP design serves as the exterior shell of the package. Consequently, the Syreen reduces the package weight and volume from today's standard packaging by thirty percent and fifty percent, respectively, by doing away with the necessity for unnecessary fillers like cardboard and Styrofoam. Because of this, Syreen cuts 50% off transportation, storage, and associated CO2 emissions. It also eliminates 40% of a conventional supply chain43.
"Tamper-resistant" is a term used by manufacturers to suggest that their products are made to survive being disassembled, removed, or tampered with by prisoners to prevent damage, destruction, or interference. When developing packaging for pharmaceutical items, one of the main factors taken into account is the need for tamper-resistant packaging44.
Figure 13: Tamper-resistant packaging
The FDA accepts the following arrangements as tamper-resistant packaging: Shrink seals, bands, bubble packs, blister packages, strip packages, and film wraps Paper, plastic pouches, oil, breakable caps, bottle seals, tape seals, and aerosol canisters45.
There are two innovations in talking packaging, the Talk Pack and NFC tags.
Wipak Walsrode makes a packaging method called Talk Pack. Any printed picture or any of the package materials might be connected to it46. It has a unique kind of pen-shaped reader inside. It is used to retrieve saved but inaccessible data, such as audio files that provide the audibility of voice, music, and other sounds.
Customers may use this to learn more about different brands, manufacturers, shelf lives, and other relevant information47.
Figure 14: NFC tag
Customers may download text, audio, or web page product information using mobile phones with NFC tags. Just tap the code on the package to have it played back on that specific phone. Patients who are visually challenged might benefit from the pharmacy staff's vocal dosage instructions48.
These technologies provide each stock unit with a unique identification during the production process, and this identity is maintained until the stock unit is depleted. This identification contains a lot number, expiration date, and product details like name and strength49.
RFID (Radio Frequency Identification):
RFID is a technology that tracks objects at a distance using small computer chips. This little chip is attached to an antenna that picks up electromagnetic radiation that a reading device emits50. The reader device receives the unique identification number from the chip when the energy is detected. This makes it possible to identify the object remotely. In addition to aiding with cost management and achieving patient safety goals, this technology offers effective inventory management51. The tag is made up of an integrated circuit containing an electronic product code (EPC), and a special tracking identification. With the use of electromagnetic radiation waves, this code is communicated over the radio spectrum52. The reader receives this sent signal and records it, helping to establish a connection between the tag data and the system software. The program can be enhanced with anti-counterfeiting tools53.
Figure 15: RFID
Finally, it may be concluded from the review article that the pharmaceutical packaging industry is somehow engaged in the manufacturing process of the drug product. That’s why it becomes necessary that the packaging material we use enhances the value of the product. Because of the rising demand for advanced pharmaceutical packaging in the market, huge development has occurred. The acceptance and utilization of the latest techniques are required to attain better results. Pharmaceutical product packaging appears to be promising as a result of new techniques like Syreen prefilled syringe design and Cypak advanced medication. In conclusion, there are several chances to enhance medication efficacy and patient experiences due to the constantly changing environment of drug packaging and delivery systems.
With the cooperation of scientists, producers, and authorities to tackle obstacles and utilize these advancements, the way towards safer, more efficient, and patient-focused medications is becoming more evident.
The authors have no conflicts of interest regarding this investigation.
The authors would like to express their special thanks of gratitude to the HOD of the Pharmaceutics Department DR Abdul Ahad Ahad for their guidance and support in completing this article.
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Received on 29.02.2024 Revised on 18.07.2024 Accepted on 21.10.2024 Published on 18.12.2024 Available online on December 21, 2024 Asian J. Pharm. Tech. 2024; 14(4):346-354. DOI: 10.52711/2231-5713.2024.00056 ©Asian Pharma Press All Right Reserved
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