Best Practice Recommendations Regarding the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

Abstract

The palatability of oral drugs influences patient adherence to prescribed regimens, especially for children. Various factors influence palatability, including smell, taste, texture, and dose volume. Evaluation of these factors plays an important role in pediatric drug development and is a target for regulatory scrutiny. The Global Alliance for Pediatric Therapeutics, a public-private consortium under the guidance of the Institute for Pediatric Innovation, convened the Alliance Palatability Working Group to discuss the issues related to the assessment of palatability in the development of pediatric oral dosage forms. An extensive scientific literature search was conducted, in addition to a multicompany industry survey and a series of workshops with the Alliance Palatability Working Group. Based on the results, 3 best practice recommendations emerged regarding the assessment of palatability for oral dosage forms in pediatric drug development. These best practice recommendations offer researchers guidance for the preclinical and clinical assessment of palatability of oral dosage forms and serve to operationalize the assessment process within the overall drug development program.

Development and content validation of the Pediatric Oral Medicines Acceptability Questionnaires (P-OMAQ): patient-reported and caregiver-reported outcome measures

“…Although there is a need for routine assessment of pediatric acceptability throughout pharmacological and clinical development, no standardized measurement methods or evaluation criteria exist to define acceptability of pediatric medicines [9,20,22]. A recent study highlighted that, although there are several reports on pediatric acceptability, certain attributes are inadequately researched, including the effects that the shape, size, and dimension of tablets as well as the volume of liquids can have on acceptability [9].…”

“…Consequently, acceptability is not being routinely measured as part of pediatric drug development during clinical trials [20,22]. Clinical outcome assessments (COAs) are needed to capture patient and caregiver perspectives on pediatric medicine acceptability.…”

Buccal Dosage Forms: General Considerations for Pediatric Patients

“…Frequently in dosage forms for children, colorants and sweeteners are required to increase acceptability (110). Some sweeteners include natural sugars as glucose, fructose, and sucrose; however, since buccal dosage forms are often intended to remain long periods in the buccal cavity, they may cause an acid pH favoring the appearance of caries (111,112).…”

Examining a New Scale for Evaluating Taste in Children (TASTY)

“…[11][12][13][14][15] Regulatory agencies and legislative bodies, including the FDA and the European Medicines Agency (EMA), have highlighted the importance of palatability in pediatric drug development where labeling is sought. 7,16,17 However, there is no standardized methodology for assessing taste and no consistent guidance on taste performance standards. 4,18 In fact, much of the knowledge relating to palatability assessment is concentrated in the food industry, which enjoys greater freedom to operate with regard to food product taste testing than does the pharmaceutical industry.…”

“…4 In a 2013 survey of pharmaceutical companies, respondents were overwhelmingly interested in advice from the FDA and EMA on validated tools and assessment criteria for evaluating pediatric medication taste preferences. 16 A commonly used method for pediatric self-report of subjective experiences with taste are hedonic "faces" scales. Faces scales use a series of illustrations depicting varied facial expressions to demonstrate a spectrum of sensory experiences, thereby eliminating the need for the child to quantitate their experience numerically.…”