Mini-pumps for bolus injection contribute to keep pace with the requirements for drug delivery devices driven by specific properties of protein therapeutics in combination with particular usability needs. Introductory Sect. 11.1 reflects on the growing requirements on drug delivery devices for biologics in connection with new indications and user groups. Section 11.2 discusses the boundary conditions, physical basics and technical requirements. Section 11.3 deals with the different types of pumps and their classification. In Sect. 11.4, the different drive concepts and their application areas are discussed and Sect. 11.5 looks at new trends and related requirements for mini-pumps. Finally, Sect. 11.6 makes considerations on USA and EU regulations applicable for those devices.
KeywordsDrug delivery device Mini-pump Bolus injector Pen injector Patch injector Micro-dosing pump
- 4.Poiseuille JLM. Recherches expérimentales sur le mouvement des liquides dans les tubes de très petits diamètres. CR Acad Sci. 1840;11:1041–8.Google Scholar
- 10.Dias C et al. Tolerability of high-volume subcutaneous injections of a viscous Placebo buffer: a randomized, crossover study in healthy subjects, AAPS PharmSciTech. Oct 2015;16(5).Google Scholar
- 11.Berteau C, et al. Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance. Med Dev Evid Res. 2015;8:473–84.Google Scholar
- 12.COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices, 1993L0042—EN—11.10.2007— 005.001.Google Scholar