Pharmaceutical packaging as a messenger
Orion Corporation is the flagship of the Finnish pharmaceutical industry, which ambitiously develops, manufactures and markets medicines for the most serious diseases, such as various cancers. The pharmaceutical company's wide product range also includes more conventional prescription and self-medication drugs, vitamin preparations, dietary supplements and creams. Orion is the largest employer in the pharmaceutical industry in Finland.
There are many types of pharmaceutical packaging. The drug form determines the properties of the container closure system and whether the primary package is a bottle, a tube or even a blister pack. Nothing should migrate or leach from the primary packaging into the drug product - not microscopically small plastic stains, dyes or compounds from the aluminum cap or the plastic coating on the bottom. The container material is carefully selected to suit the drug product to be packaged. For example, a solution drug may react with glass, making plastic better for certain drug preparations.
Pharmaceutical packaging plays an important part in pharmaceutical safety and the quality requirements for packaging are strict. However, the main selection criterion for packaging is the same as for all other packaging - product protection.
"Patient safety is also vital, and child-resistance of closures, for example. The choice of primary packaging is a balance between safety, regulatory requirements and user preferences. In addition, availability of solutions from suppliers plays a great part" explains Elli Kultanen, Orion's primary packaging development manager.
Primary packaging materials are vigorously tested to ensure safety. Migration tests can be performed by either the supplier or the user of the packaging. In addition to the studies required by the Pharmaceuticals Act, Orion commissions various other studies on pharmaceutical primary packaging. For example, packaging materials in contact with a drug can be exposed to high temperatures and solvents to see if any compounds are released from the materials that could affect the safety of the drug.
In addition, Orion conducts various tests to ensure the functionality of packaging - For example whether the tablet is easy to push out of its blister or how many times the dosing pump needs to be pressed before ointment comes out. In addition, it can be tested how easy or difficult it is to open a child-resistant cap or whether an elderly-friendly cap works as it should.
Drug development is a long-term task that can take up to 15 years. However, Orion's development work is also being done in other areas: developing packaging to be more environmentally friendly will take the company towards an even more sustainable drug product manufacturing.
The environmental aspects caused by the operations have also been raised in the pharmaceutical industry. Orion has been working for years to reduce the carbon footprint of its pharmaceutical manufacturing. The company aims to be carbon neutral by 2030.
"Although the role of packaging in the overall environmental impact of drug treatment is small, there is always room for improvement" says Elli Kultanen.
The product and the packaging should be taken into account together when the environmental impact is estimated and thus should not be separated. The marketing authorization is granted for the drug product and the container closure system as a whole. When developing a new pharmaceutical product, sustainability aspects are easier to take into account - making changes to current drug product packaging is costly and time-consuming, as all studies performed to the container closure might need to be repeated for a change in the marketing authorization. The primary packaging of drug products cannot be replaced on light grounds, and changes to the primary packaging will only be made for compelling reasons. For example if there are changes to the requirements and regulations, there is a change in the composition of the material or the manufacturer of the packaging no longer offers the same type of packaging for one reason or another.
The European Union's directives, the requirements of the Pharmacopoeias, the requirements of the US FDA and the local authorities of many other countries set their own requirements for the packaging of drug products. The regulations of all the countries to which the medicinal products are exported must be taken into account both in the design and in manufacture of the drug product and in the suitability of the container packaging material for the product.
In addition to the regulations, the requirements for packaging are influenced by, among other things, the group of patients using it and the typical use and circumstances of the drug product administration, the market areas and their climatic conditions. Production requirements are also an important criterion: the existing packaging lines of the drug product manufacturer and the packaging solutions available on the market limit the options for selection.
The main function of the drug product packaging is to protect the medicine while maintaining its effectiveness and safety. The packaging repels for example oxygen, light, moisture and microbes. In addition, the packaging prevents the drug product from entering the environment.
"The drug product packaging must also look like pharmaceutical product packaging in consumers' minds. The packaging must be distinguishable from other drug products so that the consumer does not mix it with another drug product. A good drug product package is such that the user recognizes it at a glance" says Elli Kultanen.
The best place to store the drug product after opening is in the original package. Of course, the drug retains its properties even when it is dispensed from the package to a pill dispenser, but for less time than in its own package.
Prints strictly regulated
Everything that is printed in pharmaceutical packaging is there for a reason.
"For example in Finland, the regulations concerning the information contained in the packaging come from the Finnish Pharmaceutical Safety and Development Center Fimea in Finland. The information contained in the package must be clear and approved by Fimea when applying for a marketing authorization. Marketing authorizations in the EU are granted by the European Medicines Agency (EMA)" says Elli Kultanen.
Both the primary and secondary packaging must always state the trade name of the drug product and the name of the active substance. The packaging also contains information about the amount of drug product inside, for example the amount of capsules or liquid and what the strength of the drug product is.
The packaging also verifies the authenticity and integrity of the medicine. For example, security stickers and seals can be added to the packaging, from which the user can see that the medicine has not been tampered with in the logistics chain. The serialization ID can be used to authenticate the authenticity. These intelligent features aim to prevent counterfeit medicines from entering the legal distribution channels.
Drug product contains important information
If the drug product is removed from its packaging, all important information about the drug product and its use are no longer available. The information printed on the packaging provides information on what the drug product is and how to use and how to store it properly. The fonts and colors of the information to be printed must be chosen in such a way that, for example, the elderly and the visually impaired have a clear and essential view of the name and strength of the product, also printed in Braille.
There is even more information inside the secondary packaging - the package leaflet contains a full booklet of information on the use, storage, possible side effects and much, much more of each medicine.
"Because the printing of medicine packages is strictly regulated, for example a carbon neutrality label cannot be printed on the drug product package" Elli Kultanen says.
Consumers are vigilant
Drug product users also give Orion a lot of feedback - there are questions about both the functionality of the packaging and the sometimes seemingly empty pill bottles.
"Some drug products have pill bottles that seem quite empty and have only a few tablets. This is a technical and economical option, as the production lines have been optimized for a certain packaging sizes, and having a large portfolio of different size options is not a more sustainable option. Sometimes a small number of tablets can be the maximum dose in the course of treatment, and the container will thus be quite empty" Elli Kultanen replies.
Consumers are also concerned about recycling issues. Orion's website contains instructions for disposing of and correct sorting of drug packaging. Some pharmacies have also printed the instructions and placed them next to the medical waste bins in pharmacies.
"There is a lot of good pressure from the drug product end users and healthcare professionals to develop even more sustainable options for drug product packaging. Packaging raises a lot of interest."
PVC has superior properties
A common topic is the Polyvinyl chloride material of blister packs. Blister packaging is currently not recyclable in many markets because of the combination of PVC and aluminum. However, the packaging has many other advantages:
"Blister packaging is a very hygienic form of packaging and it also protects the tablets from moisture better than the plastic jars. In some studies blister packaging can be seen to prevent accidental overdosing, as you have to take each tablet one-by-one."
PVC is used in blister packaging due to its superior molding properties. - The “cup” where the tablet or capsule will is quite small in size, so the material must be very malleable. The cups in the blister packaging are formed by either heat and force. In addition, coloured PVC protects the drug product very well from light.
Packaging suppliers and research institutes have an important role to play in developing new types of packaging solutions. There are many things to consider before making modifications to drug product packaging, starting with marketing authorization requirements for changes.
"If, for example, the height of the package changes, a variation to the Marketing Authorization must be submitted. Therefore, the aim is to introduce a new type of packaging for new products, unless the packaging needs to be replaced for other reasons."
Suppliers of primary packaging for Orion's products come from abroad, there is no supply in Finland. "Instead, in secondary packaging, domestic suppliers play an important role."
Data is of great importance. - We monitor and collect information about our own processes and use the information to gain understanding of our material handling processes and of where there is room for improvement. Choices and projects regarding packaging sustainability are based on data to ensure the effectiveness and impact. Once data has been collected or provided, it is determined what are the relevant areas for improvement and what are the things that can be affected.
For example, it is environmentally sustainable to choose packaging that does not cause drug product loss. The product, for example an ointment, should be easy to be taken out of the package and used up to the last drop. Similarly, in production, the aim is to minimize the amount of waste. Sustainable packaging can be sorted for recycling in the market in which it is used or efficiently processed in the medical waste stream.
Product development plays a major role in reducing the life cycle carbon footprint of pharmaceutical products. Orion has commissioned an LCA (life cycle assessment) analysis of its dry powder inhaler for the treatment of asthma, which was used to determine where efforts to reduce environmental impact should be focused. An inhaler is a device that delivers a powdered or aerosolized drug to the patient's lungs.
The development of the dry powder inhaler, which began in the 1980s, aimed to develop a propellant-free inhaler for environmental reasons. Due to the development work, the carbon footprint of the powder inhaler currently in use is very small compared to propellant aerosols.
"However, we do not have the resources to perform LCA studies on all of the packaging we use. That is why it would be good if the supplier or manufacturer can provide LCA data" Elli Kultanen hopes.