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"Managing Finished Product Testing Challenges
in Dual-Chamber Devices"
Purpose: Finished product testing of lyophilized drug products, intermediates or diagnostics for their developmental evaluation or commercial lot release already embodies a unique set of methods. In addition to the standard counterpart tests for Ready To Use products such as “chemical/biochemical, microbiological and purity”, the unique critical quality attributes which define success or failure in lyophilized presentations such as Residual Moisture, Physical Cake Appearance and Reconstitution Time present greater challenges when testing in dual-chamber devices such as cartridges and syringes. Performing such tests in the original container, rather than having to move the sample to a secondary container, is often crucial to achieving the most reflective, environmentally uninfluenced measurements indicative of the product’s quality level.
Methods: Modifying standard methods to allow for testing directly in the dual-chamber devices to achieve the same expected accuracy and precision of results is a major challenge during the product development process. Furthermore, varying styles and types of dual-chamber devices can create a need for adaptation of the methods for each new product. For instance, residual moisture analysis can consist of a Methanol extraction of moisture by soaking the lyophilized cake or by heating the cake to displace moisture from the cake via a carrier gas. Both techniques can be performed in the original primary container or in a secondary container. Reconstitution time can be evaluated under a continuous swirl or on an intermittent basis after diluent addition, while the force and style of swirling applied during each approach can also vary. Evaluating the physical appearance of the original package, although partially more restrictive in a dual chamber due to the cake being optically shielded on one size, can assist the development scientist in determining the resulting structure of material directly as it pertains to the lyophilization process outcome.
Results: This review aims to highlight the specific challenges in making quantifiable quality assessments of finished product testing across a wide array of dual-chamber product presentations and strives to provide insight on ways to manage the needed adaptations. These challenges and inherent method alterations should demonstrate a more accurate representation of the true product characteristics which will allow the developer to better address the impact of changes to the formulation or process through finished product testing.
Conclusions: Many physical challenges are associated with performing finished product testing of lyophilized presentations in dual-chamber devices. Adaptations of testing methods during drug product development are often required due to the wide range of available device configurations. The objective of these modifications is to achieve the same level of accuracy for finished product testing in these novel devices, as is achieved with standard vial presentations. These highlights will assist development scientists in understanding the potential hurdles of finished product testing in novel product delivery devices and provide confidence that an accurate assessment of the drug product is achievable.
For a copy of the poster presentation, CLICK HERE
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