Book: Pediatric Formulations – A Roadmap

See the new book, edited by Hannah Batchelor and Klaus Rose.

• Written in cooperation with the EuPFI -European Pediatric Formulation Initiative and the AAPS
• Contributors are leading globally recognized experts in the field
• Provides a comprehensive treatment of pediatric drug development

Description: Since the first edition in 2014 pediatric drug development has expanded in several dimensions. There have been significant changes on the technical level, as have been in the assessment of the regulatory demands. This 2nd edition gives an overview and update on both aspects. This is not a “how to formulate“ textbook, but an attempt to equip the reader with necessary information on the technical, the regulatory, and the historical level.

Chapter 4

Acceptability of Formulations: Testing Strategies

In recent years, acceptability of formulations by pediatric patient populations has come to be considered as a key factor for patient adherence. Subsequently, due to the related impact of acceptability on efficacy and safety, the latest guidelines and recommendations from regulators and health agencies (EMA, FDA, WHO) highlight the importance of this key factor which must be considered in the design of medicines appropriate for pediatric populations. Acceptability is defined by the EMA as the overall ability and willingness of the patient to use and their caregiver to administer the medicine as intended. This multifaceted concept is likely to be driven by both the different product features and the patient’s characteristics. From newborns to 17-year-olds, the pediatric patient population is particularly heterogeneous with regard to their perceptions, cognitive and physical capabilities. The assessment of patient acceptability, for these different sub-populations, requires a cross-functional effort to cover their different needs during the entire development process, from the early phases of formulation to the final marketing authorization. In this chapter, EMA recommendations are presented as a guide to address the various expectations. Ongoing efforts to investigate patient acceptability for oral dosage forms are summarized. Aspects such as shape and size, formulation type (e.g., tablets, granules, liquid preparations), palatability, and swallowability are covered. For various dosage forms, the method of administration, packaging configurations, and their overall usability will be discussed. Based on the literature, an overview of methods for assessing acceptability is provided and discussed. The chapter also identifies potential gaps in the field and elaborates on challenges faced by the industry to achieve adequate acceptability for a pediatric dosage form.

See the chapter

Thibault, V., Sabrina, B.D.C., Leonie, W., Fabrice, R. (2026). Acceptability of Formulations: Testing Strategies. In: Batchelor, H., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 58. Springer, Cham. https://doi.org/10.1007/978-3-031-77240-5_4

Chapter 5

Palatability of Oral Dosage Form: Considerations for Pediatric Patients

The sense of taste is defined as a part of the sensory system in which taste receptors are able to detect a variety of chemical molecules and provide valuable information allowing the discrimination of five basic tastes: sweet, sour, salty, umami, and bitter. Humans have about 25 different receptors for bitter taste that belong to the G-protein-coupled receptor superfamily. They can detect at least 1000 chemicals and herbal compounds. Among these, many active pharmaceutical ingredients (API) are characterized by an unpleasant taste that hinders patients’ willingness to take their medicinal products. Based on the FDA draft guidelines, palatability has been defined as “the quality of a pharmaceutical product that makes it agreeable or acceptable in taste, aftertaste, odor and texture.” It is therefore essential during the development of a pediatric drug to evaluate whether an adverse taste is expected, as well as the mouthfeel, in order to ensure formulation palatability.

This chapter focuses on the mechanisms of interaction between the API, the galenic forms, and all the orosensory receptors and provides a comprehensive overview of the state-of-the-art research on palatability of oral dosage forms. Moreover, an overview is given about available in vivo test methods in order to present the meaning of evaluating sensory perception.

These are the Human Taste Panel, Sip and Spit Studies, and the BATA model (Brief-access taste aversion). For the in vitro tools, e-tongue model and cell-based model are shown. Less common methods such as amoeba-based assessment or methods using zebrafishes are also discussed. An additional part will discuss the options of in silico modeling of taste.

See the chapter

Pensé-Lhéritier, AM., Wagner-Hattler, L. (2026). Palatability of Oral Dosage Form: Considerations for Pediatric Patients. In: Batchelor, H., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 58. Springer, Cham. https://doi.org/10.1007/978-3-031-77240-5_5

Chapter 6

Taste Masking Technologies

The taste and flavour perception of active pharmaceutical ingredients (APIs), particularly bitterness, is a contributing factor to acceptability of pharmaceutical oral dosage forms. This is especially significant for paediatric patients who have an increased sensitivity to aversive tastes compared to adults. Various strategies can be employed to mask the aversive taste of oral formulations, as such improving acceptability of paediatric medicines. These strategies can be categorised as either obscuring taste sensors or taste concealing. For obscuring the taste sensors, the taste pathway can be exploited using blocking or competing agents, such as bitter blockers, or sweeteners and flavouring systems which are the most commonly applied taste masking approaches in approved oral paediatric products, the majority being liquids. Taste concealing can be achieved by physical separation of the API and taste receptors via entrapment or encapsulation technologies, for example, film coating, use of lipids, ionic resin complexation, and spray congealing. It is critical to evaluate the effectiveness of the taste masking approach during product development by employing in vivo (e.g. human panels and animal models) and/or in vitro methods (e.g. dissolution and sensor-based approaches). Standardisation of the methods requires further exploration for reproducible and reliable assessments in paediatric medicine development.

See the chapter

Patel, K., Turki, R., Issa, S., Liu, F. (2026). Taste Masking Technologies. In: Batchelor, H., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 58. Springer, Cham. https://doi.org/10.1007/978-3-031-77240-5_6

Chapter 8

Paediatric Solid Formulations

Oral drug delivery is the predominant and favoured route of administration across all age populations, given its convenience for patients and cost-effective manufacturing methods. Solid oral formulations, with their diverse range of dosage forms and delivery system designs, represent the most common modality for drug delivery. Conventional adult strength tablets and capsules rarely meet the dosing and administration needs of the heterogeneous paediatric population, ranging from neonates to adolescents. Nevertheless, (smaller) monolithic dosage forms tailored to age-appropriate strengths and sizes might be preferable for (younger) children and adolescents, and patients with chronic conditions who require more frequent medication intake. More contemporary oral dosage forms, including mini-tablets, multiparticulates, (oro-)dispersible, and chewable preparations, offer several advantages related to patient acceptability, safety, and access. These formulations can facilitate easier swallowing and provide dosing flexibility, two key attributes which have traditionally favoured liquid formulations over solids for younger children. With heightened efforts to develop better medicines for children, evidence and experience of how different solid oral dosage forms can be used in this population are steadily growing. This chapter describes the rationale for different solid oral dosage forms, current regulatory recommendations related to their pharmaceutical development, and emerging evidence of their acceptability and use across the paediatric population.

See the chapter

Ranmal, S.R., Barker, S.A., Tuleu, C. (2026). Paediatric Solid Formulations. In: Batchelor, H., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 58. Springer, Cham. https://doi.org/10.1007/978-3-031-77240-5_8

Chapter 9

Micropellets: A Modern Multiparticulate Technology Platform for Pediatric Medicines

Multiparticulates like pellets and micropellets are an ideal approach to provide oral solid dosage forms, which are most suitable for the pediatric and the geriatric population. Micropellets are a versatile, integrated technology platform allowing a wide variety of oral drug products. A broad range of dosage strengths can be achieved when different quantities of a micropellet product are filled into capsules, stickpacks, or sachets. Micropellets can be administered as such into the mouth directly, sprinkled on food, or dispersed in a liquid.

With one basic micropellet core formulation concept, different drug release profiles, such as immediate release, controlled, or modified release, can be realized. Established technologies with proven scale-up concepts are capable of providing modern micropellet-based medicines to developing countries at a viable cost. Compared to micropellet technologies, the production of mini-tablets is technically more complicated and challenging. Simpler containment concepts are applicable to very effective “high potent” drug compounds with the micropellet concept.

Intelligent formulation and development concepts for formulation and clinical development would ideally go with the final market formulations from the very beginning. This strategy can avoid preliminary simple enabling formulations and reduce bioavailability bridging studies to the minimum.

See the chapter

Pöllinger, N. (2026). Micropellets: A Modern Multiparticulate Technology Platform for Pediatric Medicines. In: Batchelor, H., Rose, K. (eds) Pediatric Formulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 58. Springer, Cham. https://doi.org/10.1007/978-3-031-77240-5_9

See the full book here

Hannah Batchelor, Klaus Rose, Pediatric Formulations, Springer Cham, Hardcover ISBN
978-3-031-77239-9, Published: 17 February 2026, DOI: https://doi.org/10.1007/978-3-031-77240-5