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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 />

41

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