Factors influencing the design of a multiparticulate dosing device
Paediatric specific medicines have become increasingly researched since the introduction of paediatric investigation plan requirements in 2007. Various dosage forms continue to be investigated for their appropriateness for children, including multiparticulates.
Multiparticulates are currently available as tablets, capsules, sachets and medicated spoons/straws/syringes. These presentations offer limited dose flexibility with some only providing a single fixed dose. A device capable of repeated flexible multiparticulate dosing is therefore required to exploit the inherent flexibility of the dosage form and allow for patient-specific personalised dosing.
This thesis takes a user-centered approach to conceptualise multiparticulate dosing devices through qualitative participatory design studies with user groups including children, caregivers and patients. Having explored User and Formulation requirements in terms of device design, a device specification has been generated with subsequent concept generation and mechanism prototyping.
The research with users provided further understanding of the different contributors to ease of use, and highlighted the importance of device simplicity, accuracy and speed of use.
Exploration of the concepts of self-administration and context of use with potential paediatric MP device users discovered that self-administration was more than a single step process. Caregivers also found it difficult to provide an age at which they would be happy for their child to self-administer and highlighted various influences upon their decision including child maturity, adult supervision and child familiarity with administration.
A knowledge gap surrounding the use of mass-based mechanisms to determine multiparticulate dose has also been addressed. With new knowledge surrounding MP measurement and the mechanical specifications required for a personalised dosing device presented.
A case study is presented, highlighting a possible application of multiparticulates and their dosing device in Cystic Fibrosis patients. This population was selected given their familiarity with a multiparticulate like dosage form as part of their pancreatic enzyme replacement therapy. This study demonstrates how the global device requirements (presented in this work) can be refined on a case-specific basis allowing for a refined, user-centered device specification.
This work provides an industry road map for user engagement, acting as a platform for future multiparticulate dosing device design and development, guiding multiparticulate formulation design and ultimately advancing the field of personalised medicines and improving health outcomes (particularly of paediatric patients).