The dual-chamber systems can also be made even more user-friendly if extended with auxiliary devices. For example, for multi-doses there is the dual-chamber cartridge in a pen system. These devices are especially suited for medication destined for children and older people while having the additional advantage of reducing the users’ possible fear of the needle.
THE FUTURE IN LIFECYCLE MANAGEMENT
For drug manufacturers, the dual-chamber system offers a competitive alternative for sensitive substances. They do, however, have another advantage as they allow a company to design a coherent life-cycle management strategy based on the competitive situation. For instance, innovators can put a lyophilized drug on the market in a vial at the start of a lifecycle and profit well from it. If the competition introduces the same product, the company can then focus on the user perspective. Additional value can be obtained by the use of adapters and sWFI syringes. If the market situation requires standalone features for the drug, then switching to a dual-chamber system will be an option. With pens, this solution can be further improved to enable continuing gain of market share.
KNOW YOUR PACKAGING
When choosing the packaging, comprehensive knowledge of the systems and its processes is a key factor. While the dual-chamber systems offer many competitive advantages, they also demand a high level of skill and knowledge in developing and manufacturing. For instance, the dual-chamber system has both an end and middle stopper. Construction and assembly of the syringes and cartridges must be adapted to allow for appropriate break loose and glide forces in order to make the injection process smoother.
Special technologies and processes are also necessary to enable efficient manufacturing of freeze-dried drugs. To avoid losses of the active substance, the preferred option is in-situ lyophilization. But that option demands special knowledge of both formulation and process know-how. For example, because the substance is filled into the front chamber, the distance between the API and the freeze dryer shelf is greater as compared to a vial. This difference in heat transfer and the narrower glass barrel dimension result typically in lower sublimation rates, and the composition and concentration of the excipients must be also sometimes adapted accordingly. The lyophilization cycle will be different and might be only slightly longer. However, the loss of active substance is minimized since the dual-chamber system requires up to 20% less overfill depending on the filling volumes.
ABOUT THE AUTHOR
Thomas Otto has been a Managing Director of Vetter Pharma-Fertigung GmbH & Co. KG since December 2002. He joined the company as a project engineer in 1990 after graduating from the Technical College in Stuttgart with an engineering degree in packaging technology and print processing. From 1995 to 1999, Otto managed the department of packaging materials development. From 2000 to 2002, he directed the department of research & development as Vice President.