Evaluation of Ease of Use for Pediatric Medications Requiring Decapsulation, Dissolution, or Partial Dosing: A Questionnaire-Based Study in Japan.
Caregivers find desmopressin easy to manage but challenging to prepare and administer, indicating a need for more user-friendly pediatric formulations.
Where it sits
this study against the rest of the desmopressin corpusSummary and findings
This study surveyed 312 caregivers of pediatric patients in Japan to evaluate the usability of medications requiring decapsulation, dissolution, or partial dosing. Desmopressin oral disintegrating tablets were among the formulations assessed, focusing on management, preparation, administration, and cleanup. Desmopressin was found easy to manage but difficult to prepare and administer.
Abstract
<h4>Background</h4>Solid dosage forms such as fine granules, mini-tablets, and micropellets are gaining popularity worldwide because of their longer shelf lives, lower need for preservatives, and precise dosing compared to liquids. However, international pediatric formulations are often liquids or powders, and it is unclear whether these offer advantages over single-dose packaging, which is used in Japan, for caregiver management, preparation, administration, and cleanup. The acceptability of solid forms that require extra preparation, such as decapsulation, weighing dissolved powders, or taking partial doses, remains uncertain. This study evaluated the acceptability and usability of new dosage forms that involve caregiver preparation.<h4>Methods</h4>From April 2024 to November 2025, a survey was conducted among parents and caregivers of pediatric patients aged 0-18 years visiting the National Center for Child Health and Development. The survey focused on formulations involving opening capsules, preparing suspensions, and administering partial doses. Four model formulations were selected and evaluated: tacrolimus capsules (A), mycophenolic acid powder (B), valganciclovir dry syrup (C), and desmopressin oral disintegrating tablets (D). Respondents rated management, preparation, administration, and cleanup on an 11-point scale (- 50 to + 50) compared to conventional powders. Descriptive statistics and 95% confidence intervals were used.<h4>Results</h4>A total of 312 responses were analyzed. The median patient age ranged from 3.6 to 4.6 years. Tacrolimus (A) scored highest for management but lowest for preparation. Mycophenolate mofetil (B) was considered burdensome for management and cleanup, though it was easy to administer. Valganciclovir (C) showed similar trends, with storage challenges. Desmopressin (D) was easy to manage but difficult to prepare and administer. While managing capsules and tablets was seen as convenient, the complexity of decapsulation and dissolving tablets for administration was noted. Dissolution powders indicated potential management difficulties.<h4>Conclusion</h4>Dissolution suspension forms were viewed as more challenging to manage than powders. Preparation and administration were burdensome for all, especially those requiring dissolution and partial dosing. Caregiver-friendly designs are ideal, but establishing the infrastructure for timely delivery and acceptance in clinics is essential.
Background
The study addresses the challenge of administering pediatric medications that require complex preparation, such as decapsulation or dissolution. Solid dosage forms are increasingly popular due to their stability and precise dosing, but their acceptability in pediatric care is uncertain. This research is important as it evaluates caregiver perceptions of these formulations, which can impact adherence and treatment outcomes.
Methods
A survey was conducted from April 2024 to November 2025 among caregivers of pediatric patients aged 0-18 years at the National Center for Child Health and Development in Japan. The survey evaluated four formulations: tacrolimus capsules, mycophenolic acid powder, valganciclovir dry syrup, and desmopressin oral disintegrating tablets. Respondents rated management, preparation, administration, and cleanup on an 11-point scale compared to conventional powders.
Results
A total of 312 responses were analyzed, with the median patient age ranging from 3.6 to 4.6 years. Desmopressin was found easy to manage but difficult to prepare and administer. Tacrolimus scored highest for management but lowest for preparation. Mycophenolate mofetil was burdensome for management and cleanup, while valganciclovir faced storage challenges.
Interpretation
The study highlights the complexity of administering pediatric medications that require additional preparation steps. Although desmopressin was easy to manage, its preparation and administration challenges may affect caregiver compliance. These findings suggest a need for more caregiver-friendly medication designs. However, the subjective nature of the survey and its focus on a Japanese population may limit generalizability.
Key findings
- 312 responses analyzed.
- Median patient age ranged from 3.6 to 4.6 years.
- Desmopressin was easy to manage but difficult to prepare and administer.
- Tacrolimus scored highest for management but lowest for preparation.
- Mycophenolate mofetil was burdensome for management and cleanup.
Limitations
- Subjective caregiver reports may introduce bias.
- Findings specific to Japanese context.
- Survey-based study design.
- No clinical outcomes measured.