This article will help you better understand how to choose primary packaging polymers. For all solid oral dose products, package development is an integral part of development. Identifying your preferred primary packaging polymer composition is an important first step in a successful process. A number of polymer composition are available for bottles, sachets,drums and jars. Depending on your API, understanding advantages and disadvantages of each is important. Here are a few expert tips to help you pick the right polymer and supplier when seeking pharma packaging solutions.
Choose the Right Polymer for Your Product
Plastics have many advantages for use with sensitive solid oral dosage forms.
They are cheap, strong, light, impact resistant and can be molded to required shapes to handle efficiently on pharmaceutical packaging machines and suit patient convenience.
Depending on your product requirements moisture and gas permeation and toxicity can be minimized to ensure product stability over your desired shelf life. Laminates of various polymers can also be prepared for required characteristics.
Advantages Of Plastics
- Cheap
- Strong
- Light Impact Resistant
- Moldable To Specification
Depending on your product requirements moisture and gas permeation and toxicity can be minimized to ensure product stability over your desired shelf life. Laminates of various polymers can also be prepared for required characteristics.
However once you have identified your requirements be aware of the disadvantages of the particular polymer you you have chosen. Many polymers are poor at blocking light transmission, requiring laminates or light blockers for light sensitive products. For sterile products the sterilization process can affect the chemical properties and performance of the polymer.Surfaces may require preparation for printing. Also be aware of environmental liabilities related to the decomposition of the polymer.
Disadvantages Of Plastics
- Requires Light Blockers
- Sterilization Affects Performance
- Extra Print Surface Preparation
- Decomposition Factors
Understand Your Polymer
It is often difficult to obtain the exact polymer composition from the container manufacturer. All additives and contaminants and may not be known by you and are only supplied directly to the relevant regulatory authorities. Processing residues,such as solvents and unpolymerised monomers may be present at varying levels. Processing aids, such as lubricants, are commonly used and their character should be understood. Additives which enhance the polymers performance include fillers, acid acceptors, coupling agents,colourants and plasticizers. Biodegradable substances to aid in the breakdown after use are also common. Any of these additives may be susceptible to migration, adsorption or absorption with your product. You need to understand the potential for stability issues as best you can with the knowledge available to you.
Work With Your Packaging Suppliers
The above mentioned additives may be adjusted by the polymer or container manufacturer post approval of your product. You need to have strong vendor communication systems in place so these changes do not happen without your priore knowledge and ideally you will be aware in time to carry out any required stability investigations.
It is worth understanding the type of plastic you are using, typically a thermoplastic or thermoset plastic. Understanding the type of plastic will inform you of the processing types used to manufacture it and also the required additives.It will also help you understand the performance and specifications of the polymer. Thermoplastics can be processed by a number of processes including injection molding, blow molding, extrusion molding, pressure forming and fusion molding.
“Understanding the type of plastic will inform you of the processing types used to manufacture it and also the required additives.”
Each process will require specific additives and give certain characteristics. Thermoset plastics are typically formed by compression molding, injection molding or foam molding. Have this conversation with your pharma packaging supplier and understand your primary packaging as best you can. View a list of peer recommended pharmaceutical packaging machinery and equipment suppliers here.
The performance of your pharma packaging solution is critical to product quality, meeting the above standards in a global market can only improve your customer’s experience and bring success.
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Neopac explain in this video the characteristics of Fleximed®, and how it is an innovative pharma packaging solution.
The Fleximed® product is made of a patented polymer laminate comprising two medical grade PP sheets sandwiching a layer of PET that has had both its sides coated in silicon oxide. As we have outlined in this article, this type of measure ensures that the small tube has incredible barrier properties beyond those of polymers of cyclo-olefins, and at the same time maintaining clarity and transparency. This laminate resolves many potential issues associated with other primary packaging materials as the tubes do not break or contain glass particles. There are no compatibility issues with proteins or peptides, no pH-shift of sensitive formulations, and they are free of silicone and tungsten. Fleximed® tubes are delivered gamma sterilized and can be sterilized further by autoclave at a temperature of 121°. The system also comes with various attachment options to ensure full compatibility in real world situations.