The Basics of Blister Packaging in Drug Trials
Blistering – a thin film that lets patients “pop” tablets out of a protective cavity – isn’t as common in clinical packaging as it used to be. The rise of biotech means more vials, syringes, and injectables at play in modern trials. Still, blistering is critical to the protection and integrity of many tablet-based clinical studies, and getting it right is key to trial success.
There are two types of blistering, and many clients rely on Xerimis to help them determine which is best:
Thermoform blistering is a protective film (usually transparent, but sometimes opaque) that’s heated and then formed to the size and shape of the capsule to create an airtight seal when used in conjunction with the appropriate lidding foil.
Cold form blistering is a foil counterpart that does the same job even better. Cold form provides a stronger protection against moisture and is the optimal choice for drugs with water vapor sensitivity.
Blistering decisions aren’t as simple as either/or. Cold form blistering often requires a larger blister card – sometimes by as much as 50%. This may result in blister cards that are not convenient for the end user – your patients. This challenges an industry rule of thumb: patients should be able to fit blister cards into their pockets. The trade-off is often justified by the added moisture insurance that cold form provides. If cold form blisters are required, Xerimis strives through thoughtful design to produce larger blister cards that fold into smaller, pocket-friendly dimensions.
Thermoform: A Question of Moisture
When choosing thermoform blistering, the client has an additional choice to make. There are three thermoform options of varying quality: PVC, PVDC, or Aclar. The least expensive thermoform blistering is straight polyvinyl chloride, or PVC. Few clients can use this option given its limited moisture barrier and the uncertain stability profile of most newer compounds. PVDC – coated polyvinyl chloride – provides a level of protection against moisture. The best of the thermoform options? Aclar, a clear poly-chloro-tri-fluoro-ethylene, meets the highest protective barrier and shelf life standards available in thermoform.
The Right Packaging Makes for Better Trials
Whichever blistering option you choose, it is available in child-resistant, senior-friendly blister cards that have become commonplace in clinical trials – further ensuring positive clinical outcomes and regulatory favor. Reach out to Xerimis for help determining which blistering option best matches your needs.