Objective The understanding of acceptability of existing dosage forms is limited in most of the world and hinders the development of acceptable, age‐appropriate medicines. The attributes of paediatric medicine acceptability may differ from country to country based on culture, healthcare infrastructure and health policies. This study was designed to map the acceptability of oral medicines in paediatric patients treated in hospital in India.
Methods An observational, cross-sectional study was conducted in patients aged below 18 years and taking any form of oral medication. Acceptability scores were obtained using CAST–ClinSearch Acceptability Score Test tool.
Findings 490 patients were recruited and 193 evaluations of different pharmaceutical products available in 20 dosage forms and 7 routes of administration were studied. Oral liquids (50%) and tablets (35%) were the most commonly prescribed and administered forms. Regardless of the therapeutic class and age, the oral liquids were ‘positively accepted’ in infants and toddlers. Acceptability of tablets improved with age and appeared to be generally good from the age of 6.
Conclusion This study indicates the limited progress towards adoption of age-appropriate dosage forms in India and thus impact on the acceptability of existing oral dosage forms. The key challenges posed by the adoption of age-appropriate formulations in India are (1) awareness of importance of appropriate administration and acceptability of medicines to children in India, (2) availability of age-appropriate dosage forms and (3) lack of child-appropriate medicine policies.
- dosage form
- pharmaceutical preparations
- age appropriate
- administration and dosage
Data availability statement
All data relevant to the study are included in the article or uploaded as online supplemental information.
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Contributors FR and TV conceptualised and designed the study. TV provided support in the design of the study towards the calculation of the sample size; conducted the data analysis, reviewed and revised the manuscript, and approved the manuscript as finally submitted. SS and VP supervised the conceptualisation and design of the study, supervised the recruitment process and data collection, reviewed and revised the manuscript, and approved the final manuscript as submitted. MS provided support in the design of the study towards the participant recruitment and was responsible for internal affairs at the hospitals. MS, RS and SA coordinated the participant recruitment, collected data/responses from patients and supported manuscript preparation through data analysis. SS drafted the initial manuscript and approved the final manuscript as submitted. VP, MSF, FR and TV reviewed and revised the manuscript and approved the final manuscript as submitted. SS will be acting as guarantor and accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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