Introduction

One of the greatest challenges in pharmaceutical sciences is the development of oral drug delivery systems that are suitable for children. Although formulation and manufacturing techniques have advanced greatly in recent decades, there remains a lack in the availability of licensed age-appropriate oral medicines. This difference can be mainly attributed to the heterogeneity of the pediatric population, which includes the age range birth to adolescence, different physiological, developmental and behavioural demands. Dosing, administration and acceptability of the requirements vary among each subgroup with palatability being a vital factor influencing adherence and therapeutic outcome (Chandramouli 2024). Disaggregation of pills, crushing capsules or making suspensions of adult medications is common methods of extemporaneous compounding if the product is not available in a pediatric formulation. These practices may be short-term solutions, but they come with risks of dosing incorrectly, uncertainties regarding effectiveness, and difficulties with masking undesirable tastes. These compromises could have a negative impact on treatment and patient health. It is in the light of these difficulties that regulatory international health authorities like Food and Drug Administration (United States) (FDA), National Institutes of Health (United States) (NIH), European Medicines Agency (European Union) (EMA) and World Health Organization (United Nations) (WHO) have pointed out the pressing necessity of child friendly, palatable and easy to swallow formulations (Allegaert and Sherwin 2016). Their programs are designed to improve compliance, treatment efficacy and eventually health of children throughout the globe.

For infants and young children, dose adjustment and convenience of administration is accomplished by the use of liquid forms such as drops, solutions and suspensions but they have some limitations to their development: many drugs are not soluble, they can degrade, preservatives are required, it is expensive to transport them and they need refrigeration. The limitations have caused interest in solid dosage forms which possess the stability and manufacturability of conventional tablets and the swallow ability and dose flexibility required in the pediatric market. Small sized tablet, multiparticulates and orodispersible films are some of the emerging alternatives in Tablets, films and lyophilisates are desirable dosage forms because they dissolve rapidly in the mouth, and the large units do not need to be swallowed (Turner et al. 2014). They can also be suspended in oral fluids to easily titrate doses in different stages of development. Interestingly, these formulations can be formulated as solids, increasing the stability and reducing the amount of preservative used. New excipient science, such as pH sensitive polymers and cyclodextrins, and new technologies, such as microencapsulation, has also helped to improve taste masking and dissolution. These inventions are very beneficial in Biopharmaceutical Classification System (BCS) Class II and Class IV drugs, which are poorly soluble and have an unpleasant taste (Ghourichay et al. 2021).

At the same time nanotechnology in drug delivery systems has gained a considerable amount of attention, as a result of the ability to increase dissolution rate and solubility, and enhance oral bioavailability of poorly soluble drugs. Crystalline and amorphous nanosuspensions, polymeric and lipid nanoparticles represent some of the wide range of platforms that can be modified to address the pediatric market. The scientists are working to create formulations that are palatable and easy to deliver, and at the same time can deliver drugs with enhanced bioavailability, using nanotechnology with orodispersible dosage forms (John, 2026).

Despite growing interest in pediatric-friendly oral dosage forms and nanomedicine, existing reviews largely treat orodispersible systems and nanoparticle technologies in isolation, with limited focus on their intersection for children. Most pediatric nanomedicine reviews emphasize systemic or parenteral delivery and oncology applications, while orodispersible tablet/film reviews rarely address nanoparticle engineering, age-stratified acceptability, or regulatory implications specific to pediatric use. Consequently, there is no dedicated, critical synthesis that evaluates how different nanoparticle platforms perform within orodispersible matrices for pediatric patients in terms of bioavailability enhancement, taste masking, dose flexibility, safety, and translational feasibility. This review fills that gap by integrating pediatric pharmacotherapy needs, orodispersible formulation science, and nanoparticle design into a unified, critically appraised framework. It further distinguishes itself by explicitly comparing nanoparticle systems on clinical applicability, regulatory challenges, and pathways to real-world pediatric use, rather than descriptive listings (Jacob et al. 2025).

A critical appraisal reveals that polymeric nanoparticles offer superior controlled release and mechanical robustness in orodispersible matrices but often suffer from lower drug loading and potential burst release, whereas lipid-based systems (SLNs/NLCs) provide excellent biocompatibility and taste masking yet face challenges of drug expulsion, oxidation, and physical instability during storage. Nanocrystals and hybrid lipid–polymer carriers can markedly enhance solubility and permeability for poorly water-soluble pediatric drugs, but their integration into thin films or fast-disintegrating tablets raises concerns about uniformity, dose flexibility, and scale-up complexity. Furthermore, while liposomes and some polymeric systems show promise for targeted delivery, their clinical applicability in pediatrics is constrained by limited pediatric PK/PD data, excipient safety considerations, and the absence of harmonized regulatory standards for “orodispersible + nano” combinations. Thus, selection of a nanoparticle platform must balance bioavailability gains against manufacturability, stability, regulatory feasibility, and age-appropriate acceptability in real-world pediatric use (Chen et al. 2025).

To address these unmet pediatric needs, recent studies have focused on developing orodispersible systems comprising nanoparticles with taste masking and dose flexibility and enhanced bioavailability, as shown in Fig. 1.

Fig. 1
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Overview of pharmacokinetic differences between pediatric patients and adults. [Adapted from “Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies,” by Domingues et al. 2023, Pharmaceutics, 15(10), Article 2431 (doi.org). CC BY 4.0.]

In summation, patient-centric technologies are a paradigm shift in adult formulations to genuinely age-appropriate platforms. The pharmaceutical industry is now on the journey to deliver oral medicines with the assistance of new solid dosage technologies and nanotechnology-based systems, while enhancing the various complex needs of children, caregivers and health care providers.

Although dedicated efforts such as Deng et al. (2021) have demonstrated nanoparticle-based orodispersible platforms for palatable pediatric use, comprehensive, up-to-date syntheses integrating formulation design, age-specific acceptability, safety, and regulatory pathways remain limited, particularly for non-oncology indications.

The present review provides an updated, broader synthesis of nanoparticle-enabled pediatric oral formulations across multiple dosage forms, therapeutic areas, and regulatory considerations.

Challenges of conventional oral drug delivery systems

The traditional oral dosage form such as tablets, capsules, and syrups, is physiologically and formulationally challenging for paediatric patients. Swallowing solid oral dosage forms varies widely among children and depends on developmental stage, practice, and formulation characteristics rather than fixed age cutoffs. Clinical and regulatory guidance therefore emphasizes using age-appropriate, flexible formats (such as mini-tablets, pellets, or sprinkle capsules) and assessing each child’s ability individually instead of applying rigid age limits. Another significant obstacle is palatability, which decreases adherence and treatment outcome in case of bad taste (Omidian and Mfoafo 2023) (Moreira and Sarraguça 2020). Formulation difficulties are also present: excipients safety must be carefully considered as all excipients are used in children at different levels from those used in adults; liquid formulations can be dosed in various ways but are unstable, need preservatives and are costly to store. Together these limitations highlight the critical need for age appropriate, patient-friendly oral medication delivery systems.

Methods

Search strategy and information sources

We conducted a structured literature search of the following electronic databases: PubMed/MEDLINE, Embase, Scopus, Web of Science, and Cochrane Library. We supplemented database searches with targeted searches of grey literature (conference proceedings, clinical trial registries, and thesis repositories) and manual reference-list screening of included articles. The final searches were performed on 15 September 2026, and only records available up to that date were considered.

Search terms and search strings

Searches combined controlled vocabulary (where available) and free-text terms to capture three core concepts: pediatrics, orodispersible formulations, and nanoparticles/nanoformulations. Example search string for PubMed: (“pediatric” OR “pediatrics” OR “child*” OR “infant*” OR “neonate*”) AND (“orodispersible” OR “orally disintegrating” OR “orodispersible tablet” OR “orally disintegrating tablet” OR “orodispersible film” OR “orodispersible wafer” OR “buccal film” OR “sublingual” OR “mini-tablet”) AND (“nanoparticle*” OR “nano*” OR “nanocarrier*” OR “liposome*” OR “nanosuspension” OR “polymeric nanoparticle*” OR “solid lipid nanoparticle*” OR “nanostructured lipid carrier*”). Boolean operators, truncation, and phrase searching were adapted for each database and the full, database-specific search histories are provided in an appendix.

Advances in conventional oral drug delivery systems

Liquid dosage forms

Liquid formulations are typically preferred by neonates/infants because these are flexible in dose level and are easy to swallow. Nevertheless, they have a low stability, uncontrolled release, and increased transportation as well as storage expenses. To overcome the need to take drugs regularly, sustained release varieties of medicines have been created like azithromycin ER and methylphenidate ER. Other innovative vehicles such as milk based formulations, lipid emulsions and self-emulsifying systems have also been considered to enhance the solubility and palatability. Syringe bottle hybrids, medicated pacifiers and dose sipping syringes have been introduced to facilitate administration, albeit at a cost. Drug feeding with regular feeding (nipple shields) is promising in reducing the caregiver loads and improving compliance by administering medicine during breastfeeding (Meyers 2024).

Solid dosage forms

The industry prefers solid dosage forms because they are stable, cost-effective and have proven manufacturing platforms. However, the traditional tablets and capsules cannot be used with children who have problems with swallowing. There have been innovations on segmented tablets, solid-dose pens, and minitablets to have greater dose flexibility and acceptability. It is astonishing that minitablets (2 mm) are swallowable even by infants at the age of six months, and they were more acceptable than syrups. The training programs have also shown that children are capable of being taught to swallow small-sized tablets earlier than the anticipated time, eliminating use of liquid formulations. Other ways of packaging like calendar blisters and compliance prompting designs, also help in adherence (Harris et al. 2020) (Roberts et al. 2012).

Need for specialized pediatric formulations

Children are not small adults in terms of pharmacotherapy as their physiology, drug absorption; distribution, metabolism, and elimination are very different to adult populations. Such differences imply that formulation strategies should be unique to the developmental stages. Swallowing difficulty and lack of dosing flexibility a significant obstacle is the lack of suitable dosage forms used by adults: the fixed dosage of conventional adult solid dosage forms is often inappropriate in infants and toddlers, or fixed dosage cannot be adjusted to the needs of the patient with an immature gastrointestinal tract. The importance of pediatric appropriate medicines is emphasised by agencies like FDA and EMA, as well as the incentives and requirements for pediatric investigation plans and age-appropriate formulations. Such efforts highlight the need to have specialized pediatric formulations in order to guarantee safety, effectiveness and compliance (Poellinger 2025) (Pai and Nahata 2026).

Advantages of orodispersible dosage forms (ODTs & ODFs)

The use of orally disintegrating tablets (ODTs) and orally disintegrating films (ODFs) as orally disintegrable dosage forms is becoming a promising approach to drug delivery in children. They break down rapidly in the mouth, typically that is minimally or waterless, directly addressing the swallowing problem and increasing compliance. Their formulations also allow flexibility in dosing, which can be subdivided or tailored to address the needs of each patient, thus enhancing compliance in children and patients with dysphasia or cognitive disabilities. In addition, the immediate release profile of ODTs and ODFs will facilitate uniform bioavailability and will reduce the usage of heavy swallowing aids which are obtained as excipients. The sum total of these features makes the orodispersible systems the patient-centric solutions to pediatric therapy (Shen et al. 2013) (Steiner et al. 2022).

Role of nanoparticles in pediatric drug delivery

Delivery of drugs with the help of nanoparticles provides a set of benefits that are highly relevant to the needs of pediatrics. They enhance the solubility and dissolution of low water-soluble APIs and hence oral bioavailability. Nanocarriers can be designed to have controlled or targeted release which is very important in the pediatrics since the frequency of dosing is a major problem to adherence. Significantly, nanoparticles allow this through taste masking—by encapsulating or coating bitter APIs—to enhance palatability and acceptance in children, as shown in Fig. 2. The fact that they are precise in the customization of small-dose preparations minimizes the error of dosing, which is crucial in weight or surface-area-based pediatric dosing. Additionally, nanoparticles could reduce excipient loads which could reduce excipient related toxicity risks in susceptible pediatric groups. Combined, these characteristics point to nanoparticles as a revolutionary drug delivery system in pediatrics (Tran et al. 2019).

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Summary of key factors affecting pediatric pharmacotherapy and drug development. [Adapted from "Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies," by C. Domingues, I. Jarak, F. Veiga, M. Dourado, and A. Figueiras, 2023, Pharmaceutics, 15(10), Article 2431 (doi.org). CC BY 4.0.]

Scope and organization of the review

This article offers a review of the interface between drug delivery systems that are suitable in pediatrics and nanoparticles, and in specific cases, orodispersible formulations (ODTs and ODFs). It discusses regulatory situation and design considerations of pediatric formulation, then the principles of orodispersible dosage form, formulation strategies, benefits, and constraints in children are discussed. This review subsequently examines nanoparticle technologies modified to pediatric delivery, including improving solubility, controlled release, taste masking, reducing excipients, and flexibility of dosing. It also takes into account the present condition of marketed or under-development nanoparticle-orodispersible combinations, with case studies. The opportunities and threats, as well as future directions, are identified in terms of safety, selection of excipients, manufacturing, and regulatory acceptance of nano pediatrics. Lastly, the review includes final notes and suggestions. It emphasizes how the combination of these two methods can be used to fulfil the unmet demands in drug delivery to children by combining age-dispersible systems and nanoparticle technologies.

Types of nanoparticles used in orodispersible pediatric formulations

Polymeric nanoparticles

Polymeric nanoparticles are also considered the most studied carriers to be used in pediatrics, and they are specifically promising in relation to orodispersible platforms. Nanoparticle-based drug delivery systems such as Chitosan and other functional polymers can be used to encapsulate or adsorb an active pharmaceutical ingredient, increasing solubility, releasing it in controlled form, and hiding the taste. Polymeric nanoparticles may be incorporated directly into one of the matrices of an ODT or cast into an ODF in the case of orodispersible dosage forms; their comparatively adjustable size and surface coverings permit greater dispersion in the saliva and quick disintegration (Eltaib 2025) (Elmowafy et al. 2023). The polymeric carriers also facilitate excipient reduction by virtue of high drug loading and protection of the drug from degradation shown in Table 1. However, challenges remain in terms of ensuring mechanical strength of the ODT/ODF, avoiding aggregation of nanoparticles during formulation, and ensuring palatability and safety of polymeric excipients in children (Sripada et al. 2022) (Omidian and Mfoafo 2023).

Table 1 Polymer based nanoparticles
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Lipid-based nanoparticles (SLN, NLC, liposomes, nanoemulsions)

Lipid-based nanoparticles SLNs, NLCs, liposomes, and nanoemulsions are important carriers for targeted drug delivery and nanoemulsions offer a distinct set of benefits for orodispersible paediatric formulations. These lipid carriers can enhance bioavailability by facilitating lymphatic uptake, thereby bypassing first-pass metabolism (Porter et al. 2007). Pharma Excipients For example, the integration of liposomal or SLN systems into an ODF has been shown feasible and effective. MDPI The size of lipid-based carriers is typically in the range of 50–300 nm, they often display good stability when appropriately formulated, and they can provide taste-masking via encapsulation of bitter APIs. They can be absorbed orally, allowing rapid disintegration, with the release or absorption of the lipid carrier being controlled. Most lipids employed are biocompatible on the safety side (e.g., triglycerides, phospholipids), although excipient loading and interactions with the saliva milieu should remain an issue in paediatric administration. Lipid carriers can potentially provide faster absorption onset than polymeric systems, but can be more complex to formulate (e.g. maintaining solid-state stability, preventing lipid oxidation, and acceptable mouth-feel in young children) (Rehman et al. 2024) (Subramanian 2021).

Inorganic nanoparticles (limited paediatric use)

Nanoparticles Inorganic nanoparticles (e.g., silica, metal oxides, mesoporous silica) have received less common use in children’s orodispersible formulations because of concerns regarding long-term biocompatibility, clearance in the pediatric population and regulatory approval. They offer great stability and can have very fine particle size (usually less than 100 nm) and controlled release potential, but their palatability (tastes, mouth-feel) and safety profile in children are less well established. Partial work on mesoporous silica embedded in oral lyophilisates matrices has been done but extensive translation into pediatric ODT/ODF has not been done. Pharma Excipients So, inorganic systems are a niche product, as they are normally regarded by the failures of other carriers and in situations where long-term safety data are available in children shown in Table 2 (Domingues et al. 2023) (Paul and Sharma 2020).

Table 2 Inorganic nanoparticles based formulation
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Drug nanocrystals disintegration in the mouth usually leads to swallowing

Drug nanocrystals are another approach: the API itself is scaled down to nanoscale (usually to the order of 100–500 nm) and is usually stabilised by small amounts of surfactants or polymeric coatings, thus enhancing the rate of dissolution and bioavailability (Möschwitzer 2013). When considering paediatrics using ODTs/ODFs, nanocrystals enable the use of smaller unit doses, quick disintegration and instant absorption, which is beneficial in rapid onset or flexible dosing. The problems involve, maintaining the stability of nanocrystals during processing (compression or film casting), preventing unacceptable particle growth or aggregation and acceptable taste and mouth-feel in children shown in Table 3.

Table 3 Drug nanocrystals based formulation
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Hybrid nanocarriers (polymer–lipid, polymer–metal)

Hybrid nanocarriers combine the characteristics of various materials to deliver enhanced drug loading and controlled release example polymer lipid hybrids (e.g. polymeric shell round a lipid core) or polymer metal/tagged hybrids- and may offer multi-functional behaviour (e.g. controlled release, targeted absorption and taste masking). Their application as paediatric orodispersible agents is still in its infancy, but the complex carrier design is on the rise in paediatric nanomedicine, and hybrid systems could be significant in the future. Hybrid systems can provide increased stability, control over drug loading, and better control of release kinetics and custom palatability profiles shown in Table 4. But, larger-scale safety assessment in paediatric populations, excipient risk-assessment and manufacturability of ODT/ODF should be considered prior to mass adoption (Rao and Prestidge 2016) (Jose et al. 2018).

Table 4 Hybrid nanocarriers based formulation
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Novel approaches to age appropriate oral drug delivery

Different Age groups within the pediatric population and indication of per oral dosage forms are presented in Fig. 3.

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Pediatric age groups and their preferred, applicable oral dosage forms by age. [Adapted from “Developing Drugs for Children and the Adjustment of Medication—Is It a New Challenge or an Adaptation of Past Ideas?” by A. J. Nunn, 2011, Medical Principles and Practice, 20(6), pp. 501–503 (doi.org). Copyright 2011 by S. Karter AG, Basel.]

Multiparticulate systems

Granules, pellets or minitablets, known as multiparticulates, provide high dose flexibility and better swallowing since they are small. They enable the use of film coating technologies to release in a controlled manner and mask the taste, increasing compliance. However, there are still some grittiness and mouth feel/reconstitution problems. Combining multiparticulates with food or drinks can enhance palatability, but limit bioavailability and dose accuracy shown in Table 5. Even though these restrictions apply, multiparticulates are flexible allowing fixed dose combinations and release profiles. Extrusion spheronization, spray drying and microencapsulation are manufacturing techniques that have been extensively investigated. They can be used in many new and innovative ways, such as packaging innovations like sachets, medicated spoons and dose sipping straws, however dosing accuracy is important (Roy and Shahiwala 2009).

Table 5 Multiparticulate based formulation
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Orodispersible tablets (ODTs)

The ODTs dissolve rapidly in the mouth and may not require water and can be spit-out. This makes tablets easier to comply to, and more accepted, than the conventional tablets (Slavkova and Breitkreutz 2015).

However, ODTs are fragile, and cannot be divided, limiting dose range. The benefits of fast disintegration and the flexibility of dosage may be achievable by a hybrid solution, using ODTs and minitablets technology that could offer a solution for the needs of the pediatric patient shown in Table 6 (Comoglu and Dilek Ozyilmaz 2019).

Table 6 Orodispersible tablet based formulation
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Orodispersible films (ODFs)

These ODFs have a fine polymeric strip, which are easily absorbed in the mouth, easy to administer and more palatable. They are especially helpful with children who are unable to swallow pills or capsules. Taste masking agents can be used in the ODFs and they can be given systemically or locally as shown in Table 7 (Visser et al. 2017). However, due to the limited area of films, dose restrictions are limited and production requires special machinery (Klingmann et al. 2020).

Table 7 Orodispersible film based formulation
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Chewable formulations

Soft gel capsules and chewable tablets offer an alternative to children who are not allowed to swallow solids, yet prefer them. They enhance palatability and acceptability, particularly when flavoured. Nevertheless, chewables are not always appropriate among young children and can be dangerous in terms of choking. Dose flexibility also lacks as compared to multiparticulates shown in Table 8 (Michele et al. 2002) (Chandrasekaran and Kandasamy 2018).

Table 8 Chewable based formulation
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Manufacturing challenges and quality considerations

The production of pediatric nanomedicine is challenged by several obstacles, such as scale up challenges where nanoparticle aggregation and particle size variations during drying compromise stability and bio distribution; regulatory considerations necessitating pediatric specific excipient safety tests, and detailed nanotechnology characterization; stability issues like moisture sensitivity of orally disintegrating dosage forms shown in Fig. 4 (Mennella et al. 2013) (Tan et al. 2021).

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showing different challenge and quality consideration. [Adapted from “Development of nanoparticle-based orodispersible palatable pediatric formulations,” by Deng et al. 2021, International Journal of Pharmaceutics, 596, Article 120206 (doi.org). Copyright 2021 by Elsevier B.V.]

Recent advances in nanoparticle-based orodispersible pediatric formulations

Some of Recent advances in Nano particle Based Orodispersible pediatric formulation shown in Fig. 5.

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Different types of nanoparticles utilized in nanomedicine. [Reproduced from Domingues, C.; Jarak, I.; Veiga, F.; Dourado, M.; Figueiras, A. Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies. Pharmaceutics 2023, 15(10), 2431. doi.org; licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) © 2023 by the authors. MDPI, Basel, Switzerland.]

3D-printed nano-embedded ODTs

Additive manufacturing provides an opportunity to directly incorporate nanoparticles into orodispersible films and tablets. The technology provides the ability to dose flexibly, create tablet sizes and shapes tailored to individual requirements, and form multilayer structures with taste-masking outer layers containing fast-release cores. It presents a prospect of enhanced mechanical strength and palatability of pediatric drugs, but there are difficulties in stability and mass production (Kagita et al. 2025) (Simšič et al. 2024).

Electrospun nanofibrous ODFs

Electro spinning is used to create nanofibrous films that have high surface area and disintegrate rapidly. They may be used in poorly soluble drugs and any pediatric emergency response because of the ability of these films to increase drug solubility via amorphization and to deliver rapid onset of action. Their solubility in saliva is an advantage in terms of age-controlled administration and enhanced compliance (Chachlioutaki et al. 2020) (Choi et al. 2014).

Bio adhesive nano-films for buccal pediatric delivery

Mucoadhesive films made using polymers have the ability to hold nanoparticles or dissolved drugs on the buccal mucosa over prolonged periods of time. The method is advantageous as it increases absorption, circumvents first pass metabolism, and increases systemic delivery in children. The excipient safety, mechanical strength and mucoadhesive properties should be optimized to guarantee tolerability and efficacy (Siafaka et al. 2025) (Yang et al. 2024).

Multi-layered taste-masked nano-films

Multilayer film designs are used which involve use of taste-masking outer layers and nanoparticle-loaded inner layers to enhance palatability yet retain high drug release rates upon swallowing. This approach is especially useful in bitter drugs, the taste masking of which has a direct adherence effect in children. Constructs based on film are still developing as efficacious means of enhancing treatment compliance (Nasr et al. 2022).

Recent Research Based Pediatric nano formulation and Industrial Developed formulation summarized in Tables 9 and 10.

Table 9 Research-based pediatric nano-orodispersible formulations
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Table 10 Patents and industrial developments
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Regulatory challenges

Translating pediatric orodispersible nanoparticle systems from bench to bedside is hindered by fragmented regulatory guidance, where nanomedicines and orodispersible products are assessed under separate, conventional frameworks that do not fully address their hybrid nature. Key bottlenecks include inadequate nanospecific characterization requirements, lack of harmonized disintegration and acceptability tests for “orodispersible + nano” combinations, and limited pediatric PK/PD and excipient-safety data aligned with EMA/FDA pediatric guidelines (e.g., E11 (R1). Moreover, scalability, GMP-compatible manufacturing, and stability under real-world storage conditions remain underexplored, contributing to the frequent failure of promising lab-scale systems to reach clinical use. A pragmatic translational roadmap should integrate age-stratified acceptability and disintegration testing, pediatric-relevant IVIVC and mucosal transport assays, comprehensive excipient safety assessments for neonates/infants, and early engagement with regulators to define appropriate classification and evidence requirements for these advanced pediatric formulations (Stucchi et al. 2026).

Future challenges

Recent years have seen significant collaboration between regulators, industry, and academia to advance patient centric pediatric medicines. This has led to a rise in age-appropriate formulations, with ODTs gaining particular traction as platforms for product line extensions and pediatric adaptation. ODFs are increasingly popular but face technical barriers in broadening the range of APIs and doses. Pellets and minitablets offer alternatives, though evidence of suitability for very young children remains limited.

Incentives have been used by the governments to promote development but there is always a tendency to manipulate and compound by the care givers making the need to develop scalable and cost-effective manufacturing strategies. Formulation design should be directed by patient safety, manufacturability, palatability and ease of use and it should be evaluated early in the development process and not an afterthought. This would be enhanced by reliable in vitro tools to forecast patient outcomes. Versatile technology that can be used to provide varieties of drugs, dosages, and release profiles are well appealing to industry and can even go beyond the pediatrics to the old and the special patient population. This must however be done with care so that larger applicability is not compromised at the expense of the pediatric requirements. Temporary measures like dose-flexibility with personalized dispensing in pharmacies indicate that dose flexibility is possible; although quality and safety should be maintained. There should be a moderate approach to the innovativeness and affordability to ensure that patients remain patient and can access new treatments.

Conclusion

The development of age-appropriate medicines remains complex because of the varying needs of industry, healthcare providers, caregivers, and patients. In the past two decades, many pediatric formulations have been investigated, developed, and patented, with some receiving marketing approval. Current approaches for oral drug delivery systems such as ODTs, ODFs, chewables, multiparticulates, and minitablets have shown promise, yet limited data on patient acceptability across age subgroups hinders informed choice of one approach over another. Given the heterogeneity of the pediatric population no single formulation is likely to meet all needs. Careful consideration of formulation design for each target group, supported by further research into correlations between technological aspects and patient acceptability, is essential.