Defining Patient Centric Pharmaceutical Drug Product Design

Abstract

Abstract.The term Bpatient centered,^Bpatient centric,^or Bpatient centricity^is increasingly used in the scientific literature in a wide variety of contexts. Generally, patient centric medicines are recognized as an essential contributor to healthy aging and the overall patient's quality of life and life expectancy. Besides the selection of the appropriate type of drug substance and strength for a particular indication in a particular patient, due attention must be paid that the pharmaceutical drug product design is also adequately addressing the particular patient's needs, i.e., assuring adequate patient adherence and the anticipate drug safety and effectiveness. Relevant pharmaceutical design aspects may e.g., involve the selection of the route of administration, the tablet size and shape, the ease of opening the package, the ability to read the user instruction, or the ability to follow the recommended (inuse) storage conditions. Currently, a harmonized definition on patient centric drug development/design has not yet been established. To stimulate scientific research and discussions and the consistent interpretation of test results, it is essential that such a definition is established. We have developed a first draft definition through various rounds of discussions within an interdisciplinary AAPS focus group of experts. This publication summarizes the outcomes and is intended to stimulate further discussions with all stakeholders towards a common definition of patient centric pharmaceutical drug product design that is useable across all disciplines involved.

Orodispersible films: Towards drug delivery in special populations

“…Krampe and colleagues have referred to the "gummy" nature of the films after wetting as potentially contributing to the mouthfeel of the dosage form (Krampe et al, 2015). Moreover, in the case of patients experiencing poor manual dexterity, poor hand sensitivity or reduced pinch strength (Stegemann et al, 2016), high ODF stickiness may result in the inability to properly handle the dosage form. These properties are largely related to the intrinsic properties of the carrier polymers, eg.…”

Age-appropriate and acceptable paediatric dosage forms: Insights into end-user perceptions, preferences and practices from the Children’s Acceptability of Oral Formulations (CALF) Study

“…The maturing field of clinical pharmaceutics has steered a drive towards patient-ceneterd formulation development (Liu et al, 2014, Florence, 2010, Stegemann et al, 2016. This is particularly evident in the area of paediatrics, where evolving regulatory reforms have strengthened a global focus to facilitate authorisation and access to safe and high quality medicines for children.…”

A Review of Patient-Reported Outcome Data for Palliative Cancer Drugs Approved In the European Union

“…In EU calls for policy changes in HTA models are rising. Recent EU, WHO and others findings highlight inconsistency, variability and lack of predictability in the current HTA value frameworks urging authorities to encompass all attributes recommended by the EUnetHTA Core Model® where patient perspective, including PRO, should be considered [10][11][12][13][14][15][16][17][18][19].…”