Abstract
Pens and autoinjectors are mainly used for the subcutaneous delivery of biopharmaceuticals, primarily for self-administration by the patient. The ability to self-inject has been the core driver for their development and made them such an important part of the world of drug delivery devices for more than 25 years. With the worldwide increase in diabetes as well as the trend towards biological drugs which cannot be administered orally, their importance continues to grow.
This chapter provides an overview of the different types of injection devices as well as what the development of such a device entails. Firstly, the landscape of injection devices is presented including a brief review of the different primary containers around which the devices are designed. The different types of pens and autoinjectors are described in some detail before reviewing the development process. The development sections outline the applicable regulatory requirements, provide examples of useful development tools, and then describe the different steps involved in injection device development and industrialization.
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© 2013 American Association of Pharmaceutical Scientists
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Thompson, I., Lange, J. (2013). Pen and Autoinjector Drug Delivery Devices. In: Kolhe, P., Shah, M., Rathore, N. (eds) Sterile Product Development. AAPS Advances in the Pharmaceutical Sciences Series, vol 6. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-7978-9_13
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DOI: https://doi.org/10.1007/978-1-4614-7978-9_13
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