The pharmaceutical industry today has many rules and regulations that you need to comply with, right down to what you package your pharmaceuticals in.
It is vital that the packaging selected adequately protects and preserves the integrity of the product and the selection process all boils down to the products physical and chemical characteristics, as well as its protective needs and marketing requirements.
The above can make the right packaging material complicated which is why we have compiled 5 essential pharmaceutical packaging points that you need to know.
Permeation, the transmission of gases, vapour or liquids can have drastic effects on the shelf life of a drug. If your chosen packaging material allows a subsequent transmission of water vapour or oxygen, and your products dosage form is sensitive to hydrolysis or oxidation then it can present problems.
To ensure that your packaging is not a victim to permeation then you should ask for the Water Vapour Transmission rates when purchasing materials. Further to this, keep in mind that temperature and humidity can influence the permeability of oxygen and water through plastic packaging meaning that your product may not be protected from temperature extremes.
This is the separation of chemicals from a solid which can cause drug contamination and the need to remove the product from the market resulting in a subsequent loss. Leaching is most common in plastic containers as they tend to have one or more ingredients added to stabilise or impart a specific property to the plastic.
The removal of elements from the drug product, by the packaging material. Sorption can lead to serious consequences for drug preparation when important ingredients are in the solution. As drug substances tend to have high potency and are administered in small doses it can mean losses due to sorption can significantly affect the therapeutic efficiency of the preparation.
Loss through sorption can leave the product unprotected and vulnerable to microbial growth.
Consideration of the reactivity of the drugs you are packaging need to be taken into account. Certain ingredients which are used in plastic formulations may react chemically with one or other components of a drug product, subsequently altering the appearance of the plastic or the drug.
A drug can sometimes change the physical and chemical formulations of the packaging material. This is known as a modification. This is often caused by permeation of gases and vapour from the environment or via loss of contents through the container wall, deformation in polyethylene containers is often due to this.
The material selected must have the following characteristics:
– The material must protect the preparation from environmental conditions.
– Must not be reactive with the product.
– Must not impart odour or taste to the product.
– Must be non-toxic.
– Must be FDA approved.
– Must meet tamper-resistance requirements.
In summary, when purchasing packaging material for your drug products you need to take a look at the technical information of the specific material and ensure that it provides complete climatic protection to your product such as Aluminium Barrier Foil. Browse our Pharmaceutical product range here.