Choosing the "Ideal" Oral Dosage Form for Pediatric Patients: Parents' Perspectives on Children's Preferences with a Focus on Orodispersible Tablets.

Background: Developing suitable dosage forms presents multiple challenges, such as ensuring the medication can be easily swallowed by young children, mixed with a small amount of food or liquid, and effectively taste-masked. There is no standardized guidance on pediatric dosage forms, taste preferences, or acceptable excipients, often resulting in costly delays due to required toxicology studies. Additionally, regulatory considerations around bioequivalence may necessitate further discussions between industry and regulatory authorities. Objective: This research aimed to investigate and analyze Bulgarian parents' perspectives on their children's preferences regarding different oral dosage forms, with a particular emphasis on orodispersible tablets (ODTs). Additionally, challenges related to the development of age-appropriate formulations were comprehensively discussed. Methods: A cross-sectional, online questionnaire-based study was conducted among 303 parents in Plovdiv, the second-largest city in Bulgaria, between January and March 2021. Results: The majority of parents (78.2%) reported no difficulties in administering medication to their child. Liquids were identified as the most preferred oral dosage form (68.3%), followed by tablets (21.8%). With respect to the importance of taste, most parents indicated that it is a very important factor influencing their child's acceptance of medication. Although 249 parents stated that they were familiar with ODTs, only 11.2% reported that their child had previously taken ODTs. Conclusions: The results of our study show that the taste of the dosage form is a leading factor in child acceptability. The sweet fruit flavor was a favorite among children. Parental attitudes toward ODTs were strongly positive, with 91.1% indicating a preference for their child to receive ODTs rather than conventional tablets.