For oral solid dose (OSD) pharmaceuticals, decisions regarding the type of packaging used are critical to the success of a product. The best formulated product in the world can fail if it is contained in an inappropriate package. So how does one decide which packaging to use for a product?
First and foremost, the package has to protect the product from damage or degradation. Different barriers can protect from moisture, light, or gases, such as oxygen or carbon dioxide. Blistered products may use cold-formed aluminum to block light completely. Vials, at times, use light protective sleeves for the same purpose. Bottled products may require the use of a coil to keep tablets from breaking during shipment. Alcami works with clients to customize the best package configuration for product protection.
Additionally, the packager needs to know how the product will be used and who will be using it. The appropriate package for a clinical setting may need to be blinded. When a package is blinded, the identity and strength of the product are hidden such that the patient is blind to what is being taken. Blister packaging can be utilized to make it easier to track patient compliance. A product intended for commercial distribution may need child-resistant packaging. This can be accomplished through the use of peel-push child-resistant backing for blister packs and child-resistant closures used on bottles.
The U.S. Food & Drug Administration (FDA) also plays a role in pharmaceutical packaging and labeling. In accordance with recent regulatory requirements, commercial products require serialization. Serialization provides a unique code for each individual unit of sale, allows users to track the product from the pharmacy shelf back to its source, and is put in place as a counterfeiting deterrent. It is important for a contract development and manufacturing organization (CDMO) packaging team to understand the needs of each product and develop packaging suitable for each client’s particular needs.
In one instance, a client faced the challenge of accurately tracking product usage in a double-blind study. Alcami’s packaging team overcame the challenge by packaging the drug product in blister cards that made it easy for the clinicians to see how much product was taken and determine patient compliance.
Another client was having complications with the label print rubbing off in the field. The product was stored in the refrigerator and condensation formed when the product was removed from storage. This condensation made it easy to remove some of the printing. The packaging team proposed an overwrap feature with a longer label, including a clear overwrap portion to cover the print needing protection. The use of the overwrap successfully eliminated the issue.
These examples show a few of the ways packaging can play a pivotal role in a patient’s medicine. The efficacy of a medicine is tied to the packaging of the drug product and tested through stability studies. As stated earlier, the best formulated medicine may be useless without the proper packaging.