Integrated Product and Process Design for Mass Customization: A Road Towards Patient Access to Individualized Pharmaceutical Therapy
Doktorsavhandling, 2021

Individualized pharmaceutical therapy strives to attain optimal health outcomes a priori in all patients treated with pharmaceutical products by tailoring these products to each patient’s holistic needs. However, existing mass-produced pharmaceutical products are not available in sufficient variety to enable adequate tailoring to the diverse needs of individuals. Consequently, this thesis has, firstly, recognized a potential alternative production approach designed for the provision of affordable variety, namely, mass customization. Thereafter, key product and process design requirements for establishing mass customization opportunities in the pharmaceutical value chain were identified and demonstrated. The foundation and key contribution of this thesis is a proposed patient-centric framework of design requirements for individualization of each oral dosage form feature. Additionally, an overarching product requirement for multifunctional individualization was determined, i.e., the simultaneous, independent individualization of multiple product features, which had not been addressed prior to this thesis. With a primary focus on product modularization, this thesis demonstrates that multifunctional individualization and the enhanced product variety crucial for affordable individualization may be achieved through reconfigurable modularization. Hot melt extrusion and fused deposition modelling were collectively deemed high-potential technologies for the fabrication of individualized products. However, this thesis reveals key material and manufacturing trade-offs between material diversity, dispensing precision, and geometric design flexibility, arising due to strict product and process requirements, which remain unsolved. Throughout, a systems approach is demonstrated to tackle existing interdependencies and, in future, navigate change on the road towards realization of accessible individualized therapy.

hot melt extrusion

reconfiguration

patient-centric product design

individualized therapy

pharmaceutical manufacturing

modularization

integration

mass customization

polymeric solid dispersion

fused deposition modelling

Online
Opponent: Prof. Abdul Basit, UCL School of Pharmacy, University College London, London, UK.

Författare

Rydvikha Govender

Chalmers, Kemi och kemiteknik, Tillämpad kemi, Farmaceutisk teknologi

AstraZeneca

Therapy for the individual: Towards patient integration into the manufacturing and provision of pharmaceuticals

European Journal of Pharmaceutics and Biopharmaceutics,; Vol. 149(2020)p. 58-76

Reviewartikel

Govender, R., Abrahmsén-Alami, S., Folestad, S., Larsson, A. Individualized Multidrug Therapy with Modular Dosage Forms: Expanding the Design Window for Poorly Water-Soluble Drugs

There are currently more than 7.8 billion people on earth. We all have basic needs for food, water, and shelter and we all have a basic need for good health. When we are unwell, our individual biology and behaviour, how we each interact with the environment, and our personal preferences, collectively influence whether the medicines we take are safe, effective, or acceptable for use. The diversity in individual patient characteristics across the global population means that individuals respond differently, sometimes unpredictably, or undesirably, to the medicines intended to restore optimal health. Current mass-produced pharmaceutical products are not available in sufficient variety to take all these differences into account and enable adequate tailoring to the diverse needs of individual patients. This thesis integrates the characteristics that make each patient unique into the design, development, and fabrication of personalized pharmaceutical products for the future. However, typical personalized consumer products are notoriously costly. For personalized pharmaceutical products to create value for patients and society, this is a barrier which needs to be overcome. To drive equitable access to personalized medicines, this research demonstrates how modular product design concepts can support an alternative production paradigm, called mass customization. Mass customization is geared towards the provision of high product variety for personalization without the typically associated high costs. By doing so, this thesis serves to pave the way for future personalized pharmaceutical products, which are not just safe, effective, and acceptable for use by each individual patient but also accessible and affordable to all patients who might need them.

Ämneskategorier

Farmaceutisk vetenskap

Hälsovetenskaper

Styrkeområden

Materialvetenskap

ISBN

978-91-7905-434-2

Doktorsavhandlingar vid Chalmers tekniska högskola. Ny serie: 4901

Utgivare

Chalmers tekniska högskola

Online

Online

Opponent: Prof. Abdul Basit, UCL School of Pharmacy, University College London, London, UK.

Mer information

Senast uppdaterat

2021-01-31