IN THIS ISSUE - Drug Development & Delivery
IN THIS ISSUE - Drug Development & Delivery
IN THIS ISSUE - Drug Development & Delivery
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MATHEMATICAL<br />
M O D E L I N G<br />
Mathematical Modeling for Faster<br />
Autoinjector Design<br />
By: Jonathan Wilkins, PhD, and Iain Simpson, PhD<br />
<strong>IN</strong>TRODUCTION<br />
There is an increasing demand for<br />
advanced injection devices that bring<br />
benefits around self-administration and<br />
ease of use and work with new biological<br />
drugs, which are often required to be<br />
delivered in larger volumes and/or at<br />
higher viscosities than those for<br />
conventional drugs. In order to reduce<br />
development and manufacturing costs,<br />
there is also a desire for platform<br />
devices, which can meet a broader range<br />
of drug and user requirements through<br />
simple adaptation of a core design.<br />
Unfortunately, a number of devices<br />
currently in the market do not meet these<br />
requirements and furthermore, there is<br />
often a lack of a detailed understanding<br />
of how the key design parameters affect<br />
the overall device performance. In some<br />
cases, this has led to product recalls and<br />
in other cases, resulted in challenges in<br />
adapting the designs to meet new needs.<br />
Hence, there is a commercial need in the<br />
injectables industry for better<br />
understanding of how design<br />
fundamentals affect the performance of<br />
autoinjector devices.<br />
Cambridge Consultants believe a<br />
fast and effective approach to a better<br />
injection device design is a novel<br />
combination of mathematical modeling<br />
on a desktop PC, and complementary<br />
experimental data. The use of<br />
mathematical modeling gives insight into<br />
the physical behavior of the device, and<br />
allows rapid prediction of the effect of<br />
different parameters during the design<br />
process. The more established<br />
experimental approach provides<br />
confirmatory data to support the<br />
modeling. Cambridge Consultants has<br />
deployed this methodology in a number<br />
of development projects and achieved<br />
benefits in terms of reduced<br />
development time, more robust and<br />
Schematic of the Autoinjector<br />
F I G U R E 1<br />
adaptable designs, and reduced product<br />
cost.<br />
Mathematical modeling allows for<br />
quick simulations of device performance.<br />
The effect of important design<br />
parameters, such as injection time,<br />
injection force, and shear stress on the<br />
drug, can be predicted in real-time. This<br />
allows the engineer to investigate the<br />
design space and quickly optimize a<br />
suitable set of components for a new<br />
injection device. For example, the<br />
mathematical model can guide the<br />
designer in choosing the correct driving<br />
spring, needle gauge, and plunger in<br />
order to meet the device performance<br />
<strong>Drug</strong> <strong>Development</strong> & <strong>Delivery</strong> July/August 2012 Vol 12 No 6<br />
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