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Siiskonen, Maria; Folestad, Staffan; Malmqvist, Johan

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Abstract:

Recent breakthroughs in diagnostics, genotyping and so forth, has created opportunities to satisfy the individual therapeutic needs of each patient, i.e. treatment can be tailored according to the patient’s biological attributes as well as according to behavioural and environmental factors. Medicines, when tailored to the individual needs are often referred to as personalized medicines. So far, pharmaceutical production platforms are dominated by mass production in a batch manner with limited possibilities to fully satisfy the emerging customization needs of pharmaceutical products. To face the challenge of customization in an economically feasible manner, re-engineering of the product and production concept is inevitable. The aim of the present work is to introduce a novel approach to customize treatments by structural parameterization of the medicinal product concept. The primary adaption is here evaluated for solid oral dosage forms(SODFs), e.g. tablets. The tablet concept is re-designed to embrace a modular architecture. A platform approach, more specifically the Configurable Component (CC)method(Claesson, 2006), is used for efficient configuration of product families. To support the design work, computer-aided design tools are used. The Configurable Component modeller(CCM)(Claesson, op.cit.)is used for the function-means tree modelling of the tablet concept and from this product variants are automatically generated. The properties of the generated product families are then evaluated with regards to following criteria; product variety and manufacturing complexity to identify critical trade-offs.

Keywords:

Product Design, Digital Design, Product Platforms, Platform-based Design, Personalized Medicines, Mass Customization