Towards better understanding of patient centric drug product development in an increasingly older patient population

Stegemann, Sven

doi:10.1016/j.ijpharm.2016.01.051

Cited by 15 publications

(8 citation statements)

References 102 publications

(98 reference statements)

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“…Insufficient health literacy can also affect drug delivery. It is well known fact that many people do not have sufficient health literacy and have limited ability to read and understand healthcare information [452]. According to American Medical Association more than 40% of patients with chronic illness are functionally illiterate.…”

Section: Accepted Manuscriptmentioning

confidence: 99%

Challenges and innovations of drug delivery in older age

Khan

Roberts

2018

Advanced Drug Delivery Reviews

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Both drug delivery performance and various age-related physical, mental and physiological changes can affect drug effectiveness and safety in elderly patients. The many drug delivery systems developed over the years include recent novel transdermal, nasal, pulmonary and orally disintegrating tablets that provide consistent, precise, timely and more targeted drug delivery. Certain drug delivery systems may be associated with suboptimal outcomes in the elderly because of the nature of drug present, a lack of appreciation of the impact of age-related changes in drug absorption, distribution and clearance, the limited availability of pharmacokinetic, safety and clinical data. Polypharmacy, patient morbidity and poor adherence can also contribute to sub-optimal drug delivery systems outcomes in the elderly. The development of drug delivery systems for the elderly is a poorly realised opportunity, with each system having specific advantages and limitations. A key challenge is to provide the innovation that best meets the specific physiological, psychological and multiple drug requirements of individual elderly patients.

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Section: Accepted Manuscriptmentioning

confidence: 99%

Challenges and innovations of drug delivery in older age

Khan

Roberts

2018

Advanced Drug Delivery Reviews

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“…At the same time, it may be considered that other populations may have similar needs as children, e.g. older people (40). Rather than focussing on a gold standard paediatric drugs, companies may consider the development of patient centric products that can be used to accommodate certain patient needs across a wide variety of ages (69).…”

Section: Paediatric Regulation: Progress and Future Perspectivesmentioning

confidence: 99%

Paediatric Drug Development and Formulation Design—a European Perspective

Riet‐Nales

Kozarewicz²,

Aylward

et al. 2016

AAPS PharmSciTech

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Abstract.The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize Bbetter^medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The Regulation, e.g. requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the BGuideline on the Pharmaceutical Development of Medicines for Paediatric Use.^Companies should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. In this review, the guideline's key aspects are discussed with a focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions.

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“…The provision of individualized pharmaceutical therapy, which ultimately aims to elicit optimal therapeutic outcomes a priori from all patients, requires the integration of key patient attributes into the design and manufacture of pharmaceutical products [ 1 , 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 ]. Recently, we presented a patient-centric framework of design requirements for individualized pharmaceutical products [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

et al. 2020

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Independent individualization of multiple product attributes, such as dose and drug release, is a crucial overarching requirement of pharmaceutical products for individualized therapy as is the unified integration of individualized product design with the processes and production that drive patient access to such therapy. Individualization intrinsically demands a marked increase in the number of product variants to suit smaller, more stratified patient populations. One established design strategy to provide enhanced product variety is product modularization. Despite existing customized and/or modular product design concepts, multifunctional individualization in an integrated manner is still strikingly absent in pharma. Consequently, this study aims to demonstrate multifunctional individualization through a modular product design capable of providing an increased variety of release profiles independent of dose and dosage form size. To further exhibit that increased product variety is attainable even with a low degree of product modularity, the modular design was based upon a fixed target dosage form size of approximately 200 mm3 comprising two modules, approximately 100 mm3 each. Each module contained a melt-extruded and molded formulation of 40% w/w metoprolol succinate in a PEG1500 and Kollidon® VA64 erodible hydrophilic matrix surrounded by polylactic acid and/or polyvinyl acetate as additional release rate-controlling polymers. Drug release testing confirmed the generation of predictable, combined drug release kinetics for dosage forms, independent of dose, based on a product’s constituent modules and enhanced product variety through a minimum of six dosage form release profiles from only three module variants. Based on these initial results, the potential of the reconfigurable modular product design concept is discussed for unified integration into a pharmaceutical mass customization/mass personalization context.

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Towards better understanding of patient centric drug product development in an increasingly older patient population

Cited by 15 publications

References 102 publications

Challenges and innovations of drug delivery in older age

Challenges and innovations of drug delivery in older age

Paediatric Drug Development and Formulation Design—a European Perspective

Independent Tailoring of Dose and Drug Release via a Modularized Product Design Concept for Mass Customization

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