■以患者为中心的药物产品设计没有一致的框架,尽管人们普遍认为药品的可接受性和偏好会影响依从性,因此,药品有效性。本综述的目的是评估患者对固体口服剂型(SODF)药物产品属性的可接受性和偏好的当前理解,以及这些属性对患者行为和结果的潜在影响。
■进行了范围审查。Embase,OvidMEDLINE®,和PubMed®搜索2013年1月至2023年5月发表的全文文章。根据预定义的纳入标准进行筛选和评估后,数据进行了主题分析。
■纳入了19项研究。确定并在框架中总结了药品属性的四个总体领域:外观,吞咽能力,适口性,和处理。每个领域都由特定的药物产品属性通知:质地,形式,尺寸,形状,颜色,标记,味道,口感,和气味。最常研究的领域是吞咽能力和外观,虽然研究最多的属性是大小,形状,和纹理。闻起来,标记,和口感是研究最少的属性。纹理与所有域相交,而形式,形状,和尺寸相交的外观,吞咽能力,和处理。可吞咽性和大小似乎是关键的域和属性,分别,在设计药物产品时需要考虑。很少有研究探讨药品属性对行为和结果的影响。
■虽然现有的药物产品属性研究集中在外观和吞咽能力上,这篇综述强调了两个不太了解的领域-适口性和处理-在了解患者对SODF药物产品的可接受性和偏好方面的重要性.该框架提供了一个工具,以促进以患者为中心的药物产品设计,将物理药物产品属性组织和分类为四个总体领域(外观,吞咽能力,适口性,和处理),鼓励研究人员全面评估药品属性对患者可接受性的影响,preferences,和结果。
药物有各种类型和形式。这些包括片剂和胶囊。因素,比如药片的大小和形状,会影响人们如何服用药物。然而,患者很少参与设计他们服用的药物。在这项研究中,研究人员总结了2013年至2023年发表的19项研究。他们想了解不同的因素,比如尺寸和形状,影响患者的偏好,能力,并愿意服用药物。研究人员专注于药物的“物理”方面,发现了4个共同的主题:1)它们的外观(外观),2)它们有多容易吞咽(吞咽能力),3)它们在口中的味道和感觉(适口性),和4)他们是多么容易处理(处理)。还发现了八个因素:颜色,标记,形状,尺寸,气味,味道,纹理,以及药物在口中的感觉(口感)。大多数研究都集中在药物的外观以及吞咽的容易程度上。研究人员主要关注的因素是大小,形状,和药物的质地。药物的设计可以影响不同年龄的患者,尽管某些患者群体可能有特定的需求,包括孩子,老年人,和患有某些疾病的人。患者输入应成为未来药物设计的一部分,以确保其可接受性。
UNASSIGNED: There is no consistent framework for patient-centric drug product design, despite the common understanding that drug product
acceptability and preferences influence adherence and, therefore, drug product effectiveness. The aim of this
review was to assess current understanding of patient
acceptability and preferences for solid oral dosage form (SODF) drug product attributes, and the potential impact of these attributes on patient behaviors and outcomes.
UNASSIGNED: A scoping
review was conducted. Embase, Ovid MEDLINE®, and PubMed® were searched for full-text articles published between January 2013 and May 2023. Following screening and assessment against predefined inclusion criteria, data were analyzed thematically.
UNASSIGNED: Nineteen studies were included. Four overarching domains of drug product attributes were identified and summarized in a framework: appearance, swallowability, palatability, and handling. Each domain was informed by specific drug product attributes: texture, form, size, shape, color, marking, taste, mouthfeel, and smell. The most frequently studied domains were swallowability and appearance, while the most studied attributes were size, shape, and texture. Smell, marking, and mouthfeel were the least studied attributes. Texture intersected all domains, while form, shape, and size intersected appearance, swallowability, and handling. Swallowability and size appeared to be the key domain and attribute, respectively, to consider when designing drug products. Few studies explored the impact of drug product attributes on behaviors and outcomes.
UNASSIGNED: While existing studies of drug product attributes have focused on appearance and swallowability, this
review highlighted the importance of two less well-understood domains-palatability and handling-in understanding patients\' acceptability and preferences for SODF drug products. The framework provides a tool to facilitate patient-centric design of drug products, organizing and categorizing physical drug product attributes into four overarching domains (appearance, swallowability, palatability, and handling), encouraging researchers to comprehensively assess the impact of drug product attributes on patient acceptability, preferences, and outcomes.
Medicines come in a variety of types and forms. These include tablets and capsules. Factors, such as the size and shape of tablets, can affect how people take medicines. However, patients are rarely involved in designing the medicines that they take. In this study, researchers summarized 19 studies published between 2013 and 2023. They wanted to understand how different factors, like size and shape, affect patients’ preferences, ability, and willingness to take medicines. Researchers focused on the “physical” aspects of medicines and found 4 common themes: 1) what they look like (appearance), 2) how easy they are to swallow (swallowability), 3) how they taste and feel in the mouth (palatability), and 4) how easy they are to handle (handling). Eight factors were also found: color, markings, shape, size, smell, taste, texture, and how a medicine feels in the mouth (mouthfeel). Most studies focused on what medicines look like and how easy they are to swallow. The factors that researchers mostly looked at were the size, shape, and texture of medicines. The design of medicines can impact patients of different ages, though there may be specific needs for certain groups of patients, including children, older adults, and people with certain diseases. Patient input should become a part of future medicines design to ensure their
acceptability.