How researchers are revolutionizing pediatric formulations through science, innovation, and listening to young patients themselves
We've all witnessed the scene: a distressed parent attempting to coax a crying child into taking medicine, followed by tears, tightly sealed lips, and sometimes the dramatic spit-take. While these struggles might seem like ordinary challenges of parenting, they point to a more significant scientific problem—one that pharmacists, doctors, and researchers are working to solve. Why is it so difficult to create medicines that children can and will take? The answer lies at the intersection of human development, pharmacology, and innovative design science.
For decades, children were often considered "little adults" when it came to medication, resulting in improvised solutions like crushing tablets or attempting to mask bitter flavors with sugar. However, children's bodies process medicines differently, their swallowing abilities vary by age, and their taste perceptions are uniquely sensitive.
This recognition has sparked a revolution in pediatric formulation science, dedicated to creating medications that are not only safe and effective but also acceptable to young patients. The stakes are high: when medicines are unpalatable or difficult to swallow, children may receive incorrect doses or miss treatments entirely, potentially compromising their health outcomes 3 4 .
Designing medicines for children presents a complex puzzle of physiological and developmental considerations that scientists must carefully navigate.
From a physiological perspective, children are not simply miniature versions of adults. Their bodies undergo dramatic changes that affect how medications are processed:
Beyond physiology, medication acceptance varies dramatically with cognitive development and age:
An acceptable formulation for a teenager might be impossible for a toddler to take, necessitating multiple formulation options for the same medication 1 .
Young children rely completely on caregivers for medication administration, making formulation characteristics that facilitate accurate dosing critically important 3 .
Children with chronic conditions who take medicines frequently show different preferences than those who take medicines only occasionally 1 .
To tackle the challenge of designing better pediatric medicines, researchers with the European Paediatric Translational Research Infrastructure (EPTRI) embarked on an ambitious multinational study to ask children themselves about their medication preferences 1 .
Between 2018 and 2021, the research team developed and distributed an online, age-adapted survey across seven European countries: Albania, Italy, the Netherlands, Belgium, Romania, Spain, and the United Kingdom. The survey was carefully designed with input from Young Persons Advisory Groups (YPAGs) to ensure the questions were child-friendly and understandable 1 .
The study involved 1,172 children and adolescents, representing a broad spectrum of ages, health statuses, and cultural backgrounds. Participants were asked about their experiences with different medicine forms, their preferences, and their reasons for liking or disliking specific formulations 1 .
The results revealed fascinating patterns that can guide future formulation development:
Liquid formulations were the most selected option overall (35%), particularly among children under 12 1 .
Monolithic solid forms were mostly chosen by adolescents and children with chronic diseases 1 .
Source: EPTRI Formulation Preference Study 1
The EPTRI study demonstrated that children's perceived preferences for oral dosage forms primarily differ based on age, health status, and previous experience with medicines. This highlights that "acceptability" encompasses more than just taste—it includes the overall ability and willingness of patients to use and caregivers to administer a medicine as intended 1 .
These findings have real-world implications: when medicines are unacceptable to children, treatment adherence suffers, potentially compromising therapeutic outcomes. This understanding has led regulatory agencies like the European Medicines Agency and the U.S. Food and Drug Administration to now require pharmaceutical companies to justify their formulation choices for pediatric populations 1 .
Creating child-friendly medications requires a specialized toolkit of ingredients and technologies designed to make medicines palatable, safe, and easy to administer.
While active ingredients treat conditions, excipients—the inactive components of medicines—play crucial roles in making medications acceptable to children. However, selecting appropriate excipients requires special consideration, as some that are safe for adults may be harmful to children, particularly neonates 8 .
| Excipient Category | Purpose | Examples | Pediatric Considerations |
|---|---|---|---|
| Sweeteners | Mask bitter tastes, improve palatability | Sucrose, sorbitol, artificial sweeteners | Sugar-free options preferred for long-term use; calorie content matters |
| Flavors | Improve taste and acceptability | Fruit flavors (berry, orange), bubblegum | Age-dependent preferences; younger children often prefer fruity flavors |
| Suspending Agents | Keep insoluble particles evenly distributed in liquids | Xanthan gum, cellulose derivatives | Ensure consistent dosing in liquid formulations |
| Preservatives | Prevent microbial growth | Parabens, benzoates | Some preservatives (e.g., benzyl alcohol) are restricted in neonates |
| Colorants | Improve visual appeal, product identification | FDA-approved dyes, natural colorants | Help with product recognition but should be used judiciously |
Source: Adapted from pediatric formulation guidelines 8
Beyond traditional liquids and tablets, formulation scientists have developed creative solutions to overcome administration challenges:
These innovative tablets dissolve rapidly in the mouth without water, making them ideal for children who can't swallow conventional tablets. Recent studies show strong parental preference for ODTs, with 91.1% of Bulgarian parents indicating they would prefer their child to receive ODTs rather than conventional tablets 8 .
Small, uniform pellets or granules can be sprinkled on food, providing dose flexibility and ease of administration while avoiding swallowing difficulties associated with larger solid forms 4 .
Thin, rapidly dissolving films that deliver medication through the buccal mucosa offer an alternative pathway that bypasses the taste buds and gastrointestinal metabolism 3 .
The field of pediatric formulations continues to evolve, with several promising developments on the horizon.
There's a growing movement from liquid to solid dosage forms that are easier to degrade or disperse, offering improved stability and precise dosing 8 .
For medications where rapid onset is critical, such as seizure management or pain relief, buccal delivery systems provide an appealing alternative that avoids first-pass metabolism and offers quick absorption 3 .
Emerging technology enables the production of personalized dosage forms with specific shapes, flavors, and drug concentrations tailored to individual pediatric patients.
Recent regulatory initiatives have significantly advanced pediatric medicine development:
Legislation such as the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) in the U.S., along with the European Paediatric Regulation, have created incentives and requirements for pharmaceutical companies to conduct pediatric studies 3 .
The success of involving Young Persons Advisory Groups (YPAGs) in research, as demonstrated in the EPTRI study, points toward more collaborative, patient-centric approaches to formulation development 1 .
The science of creating child-friendly medicines has come a long way from the one-size-fits-all approach of simply crushing adult tablets or trying to mask bitter tastes with sugar. Through dedicated research, scientific innovation, and—most importantly—listening to children themselves, we're moving toward a future where medicines are designed with the unique needs and preferences of young patients in mind.
The next time you see a child happily taking their medication, remember the sophisticated science and careful design that went into creating a formulation that they can and will take. In the world of pediatric medicine, getting the formula right means more than just precise chemical composition—it means understanding that successful treatment depends as much on a child's acceptance as on a drug's pharmacological action.
As research continues to evolve, the future looks promising for developing even more innovative, acceptable, and effective medicines for our smallest patients—proving that when it comes to pediatric health, good things indeed come in carefully designed packages.