Pediatric Drug Delivery Research Articles

Novel approaches in Paediatric Drug Delivery System

The development of medication delivery technology has led to an increase in the popularity of pediatric formulations. However, there is absence of secure and efficient drug delivery mechanism for pediatric patients. It is crucial to design and create a novel and suitable delivery system to guarantee precise and reliable medication administration to pediatric patients, as their pharmacokinetics and pathophysiologic profiles differ from those of adults. Under this heading, discussion will be carried out in order to increase stability; new medication delivery techniques and technology are being developed to enhance the stability, toxicity, flexibility, moreover secure aspects of pediatric oral formulations. Specifically, issues with patient acceptability and manufacturability are discussed in this section, and innovative medication delivery methods are examined to address current issues.

In vitro evaluation of intersubject variability in pediatric intranasal drug delivery using nasal spray suspension products

Evaluation of the regional intranasal delivery of locally acting drugs in children is challenging. Anatomical nasal airway replicas potentially can provide a robust pre-clinical tool to test the performance of devices and formulations. However, there is often a challenge in identifying the nasal geometries that can reasonably be indicative of in vivo regional mass distribution of administered drug. This in vitro study was designed to investigate the regional intranasal drug delivery in 20 children, 2–11 years old (50% 2–6 years old and 50% female), using two commercially available suspension nasal spray products with different nozzle designs, plume characteristics, and active pharmaceutical ingredients. High-resolution computed tomography scans of the sinonasal region of pediatric human subjects with healthy nasal airways, reviewed and scored by a head and neck surgeon, were used to develop 20 three-dimensional (3D) replicas of the nasal airways. The 3D replicas were segmented into the two regions: anterior and posterior to the internal nasal valve (INV). They were then rapid prototyped in high clarity rigid plastic (Accura ClearVue). Each side of the septum of the 20 subjects was examined separately, resulting in 40 singular nasal cavities. A nozzle-specific spray tip holder was designed for each case to ensure consistent administration (insertion length, sagittal angle, and coronal angle) in all replicates. The wide range of posterior drug delivery observed in the forty geometries indicated significant intersubject variability in pediatric intranasal drug delivery. Three nasal geometries representing low, medium, and high levels of drug delivery to the target region, posterior to the INV, were chosen from the 40 nasal cavities. Our vision is that these three nasal geometries can potentially be beneficial in determining whether performance differences between test and reference nasal spray products are present that may affect their bioequivalence in children. They also may be useful when applied in parallel with similar adult nasal geometries, previously developed following a similar procedure, to provide additional insights into pediatric nasal drug delivery with innovator products in children in lieu of extending clinical studies to include pediatric subjects.

Nutraceutically-enhanced oral delivery of vitamin D3 via Bio-SNEDDS: Demonstrating in vivo superiority over pediatric formulations

BackgroundVitamin D3 (VD3) deficiency among children in Saudi Arabia remains a pressing concern due to its poor bioavailability and the limitations of current pediatric formulations. To address this challenge, we developed a groundbreaking pediatric self-nanoemulsifying drug delivery system (Bio-SNEDDS) for VD3, fortified with black seed oil and moringa seed oil for dual therapeutic benefits. Through meticulous formulation optimization using ternary phase diagrams and comprehensive testing, our Bio-SNEDDS demonstrated exceptional performance. MethodsBio-SNEDDS were manufactured by incorporating Black seed oil and moringa seed oil as bioactive nutraceutical excipients along with various cosurfactant and surfactants. Bio-SNEDDS were systematically optimized through ternary phase diagrams, visual tests, droplet size analysis, drug solubilization studies, dispersion assessments, and pharmacokinetic testing in rats compared to Vi-De 3®. ResultsPseudoternary phase diagrams identified oil blends producing large nanoemulsion regions optimal for SNEDDS formation. The optimized F1 Bio-SNEDDS showed a mean droplet diameter of 33.7 nm, solubilized 154.46 mg/g VD3 with no metabolite formation, and maintained >88% VD3 in solution during 24 h dispersion testing. Notably, in vivo pharmacokinetic evaluation at a high VD3 dose demonstrated an approximately two-fold greater relative bioavailability over Vi-De 3®, validating the superb oral delivery performance of Bio-SNEDDS even under challenging high-dose conditions. ConclusionsThe Bio-SNEDDS provides an effective VD3 delivery strategy with established in vivo superiority over marketed products, along with offering additional health benefits from the natural oils.

Analysis of the Physical Characteristics of an Anhydrous Vehicle for Compounded Pediatric Oral Liquids.

The paucity of suitable drug formulations for pediatric patients generates a need for customized, compounded medications. This research study was set out to comprehensively analyze the physical properties of the new, proprietary anhydrous oral vehicle SuspendIt® Anhydrous, which was designed for compounding pediatric oral liquids. A wide range of tests was used, including sedimentation volume, viscosity, droplet size after dispersion in simulated gastric fluid, microscopic examination and content uniformity measurements to evaluate the properties of the anhydrous vehicle. The results showed that the vehicle exhibited consistent physical properties under varying conditions and maintained stability over time. This can be attributed to the unique blend of excipients in its formulation, which not only maintain its viscosity but also confer thixotropic behavior. The unique combination of viscous, thixotropic and self-emulsifying properties allows for rapid redispersibility, sedimentation stability, accurate dosing, potential drug solubility, dispersion and promotion of enhanced gastrointestinal distribution and absorption. Furthermore, the vehicle demonstrated long-term sedimentation stability and content uniformity for a list of 13 anhydrous suspensions. These results suggest that the anhydrous oral vehicle could serve as a versatile base for pediatric formulation, potentially filling an important gap in pediatric drug delivery. Future studies can further investigate its compatibility, stability and performance with other drugs and in different clinical scenarios.

Towards personalized drug delivery via semi-solid extrusion: Exploring poly(vinyl alcohol-co-vinyl acetate) copolymers for hydrochlorothiazide-loaded films

The increasing need for personalized drug delivery requires developing systems with tailorable properties. The copolymer poly(vinyl alcohol-co-vinyl acetate) (PVA/PVAc) allows for adjusting the monomer ratio. This study explored the effect of vinyl alcohol (VA) and vinyl acetate (VAc) monomer ratio on the properties of hydrochlorothiazide (HCT) films. Five copolymers with different VA/VAc ratios were selected and characterized. Semi-solid extrusion was employed as a method for the preparation of HCT-PVA/PVAc films to address the challenges of HCT´s low water solubility, high melting point, and low permeability. All copolymers were suitable for semi-solid extrusion, however, the mechanical properties of films with higher VA proportions were more suitable. The drug was found to be homogeneously distributed on a micrometer level throughout the prepared films. It was found that using different monomer ratios in the copolymer allows for drug release tuning – higher VA proportions showed an increased rate of drug release. Experiments through HT29-MTX cell monolayers revealed differences in HCT permeability between the different formulations. In addition, no cytotoxicity was observed for the tested formulations. The results highlight the effect of monomer ratio on film properties, providing valuable guidance for formulators in selecting PVA/PVAc copolymers for achieving desired high-quality films. In addition, varying the monomer ratio allows tuning of the film properties, and can be applied for personalization, with flexible-dose adjustment and design of appealing shapes of the pharmaceutics, not least attractive for pediatric drug delivery.

Unmet technological demands in orodispersible films for age-appropriate paediatric drug delivery.

Age-appropriateness of a formulation is the ability to deliver variable but accurate doses to the paediatric population in a safe and acceptable manner to improve medical adherence and reduce medication errors. Paediatric drug delivery is a challenging area of formulation research due to the existing gap in knowledge. This includes the unknown safety of excipients in the paediatric population, the need for an age-appropriate formulation, the lack of an effective taste-masking method and the lack of paediatric pharmacokinetic data and patient acceptability. It is equally important to establish methods for predicting the biopharmaceutical performance of a paediatric formulation as a function of age. Overcoming the challenges of existing technologies and providing custom-made solutions for the development of age-appropriate formulation is, therefore, a daunting task. Orodispersible films (ODF) are promising as age-appropriate formulations, an unmet need in paediatric drug delivery. New technological improvements in taste masking, improving solubility and rate of dissolution of insoluble drugs, the flexibility of dosing and extemporaneous preparation of these films in a hospital good manufacturing practises (GMP) setup using 3D printing can increase its acceptance among clinicians, patients and caregivers. The current review discusses the problems and possibilities in ODF technology to address the outstanding issues of age-appropriateness, which is the hallmark of patient acceptance and medical adherence in paediatrics.

Meeting Challenges of Pediatric Drug Delivery: The Potential of Orally Fast Disintegrating Tablets for Infants and Children.

A majority of therapeutics are not available as suitable dosage forms for administration to pediatric patients. The first part of this review provides an overview of clinical and technological challenges and opportunities in the development of child-friendly dosage forms such as taste masking, tablet size, flexibility of dose administration, excipient safety and acceptability. In this context, developmental pharmacology, rapid onset of action in pediatric emergency situations, regulatory and socioeconomic aspects are also reviewed and illustrated with clinical case studies. The second part of this work discusses the example of Orally Dispersible Tablets (ODTs) as a child-friendly drug delivery strategy. Inorganic particulate drug carriers can thereby be used as multifunctional excipients offering a potential solution to address unique medical needs in infants and children while maintaining a favorable excipient safety and acceptability profile in these vulnerable patient populations.

High-frequency ultrasound-guided intrathecal injections in a young mouse model: Targeting the central nervous system in drug delivery

BackgroundIntrathecal injections provide important access to the central nervous system for delivery of anesthetic, analgesic or chemotherapeutic drugs that do not otherwise cross the blood-brain barrier. The administration of drugs via this route in animal models is challenging due to an inability to visualize the small target space during injection. Successful drug delivery therefore requires expertise in indirectly assessing vertebral and spinal cord anatomy and gaining advanced procedural skills. These factors are especially compounded in small animals such as mice (the most common mammalian model) and in investigations modeling pediatric drug delivery, where the animal is even smaller. New methodTo address these issues, we have developed a method in which high-frequency ultrasound imaging is used to visualize and target the lumbar intrathecal space for injections. The technique is demonstrated in mice as young as postnatal day 16. To evaluate the method, a gadolinium-based magnetic resonance imaging (MRI) contrast agent was injected intrathecally, and subsequent brain delivery was verified post-injection by MRI. ResultsSuccessful intrathecal injections of the MRI contrast agent showed distribution to the brain. In this study, we achieved a targeting success rate of 80% in 20 animals. Comparison with existing methods and conclusionWe expect that the new method will be convenient for drug delivery to the central nervous system in rodent research and provide higher reliability than unguided approaches, an essential contribution that will enable intrathecal delivery in pediatric mouse models.

EPCT-03. Working together to accelerate the preclinical to clinical translation of drug delivery systems for children’s brain tumours

Children's brain tumours are the biggest cancer killer in children and young adults. Several techniques, such as intra-cerebrospinal fluid chemotherapy, ultrasound-mediated blood-brain barrier disruption, convection enhanced delivery, polymer delivery systems, electric field therapy, and intra-arterial and intra-nasal chemotherapy, have the potential to transform the treatment of brain tumours in children. However, there have been very few clinical trials to evaluate these. In 2021, the CBTDDC (Children’s Brain Tumour Drug Delivery Consortium) and the ITCC (Innovative Therapies for Children with Cancer) brain tumour group established a Clinical Trials Working Group comprising international researchers and clinicians to address this issue. This partnership highlighted the main challenges in preclinical to clinical translation of paediatric CNS drug delivery as: (1) a lack of specific funding for prototype development and/or scale-up for clinical trials; (2) difficulties in navigating the regulatory landscape; (3) lack of accurate preclinical models; and (4) increased need for multi-centric working. In response to this, we ran a hybrid workshop in November 2021 on ‘Clinical Trial Readiness for CNS Drug Delivery’. At this workshop, around 50 delegates (comprising clinicians, researchers, trial regulatory experts, policy makers, and representatives from funding organisations, brain tumour charities and industry) came together to discuss issues around funding, preclinical models and regulatory processes. We have established speciality-specific working groups to build on the workshop discussions, with the aim of producing recommendations around the use of preclinical models and drug delivery techniques according to brain tumour type. We have also used the workshop presentations and discussions to create a ‘Roadmap’ document for preclinical to clinical translation, which will be freely shared with the neuro-oncology research community. We continue to liaise with funders and regulatory bodies to address the changes that are needed in these areas. If you would like to join our network, contact: cbtddc@nottingham.ac.uk

Orodispersible tablets for pediatric drug delivery: current challenges and recent advances

ABSTRACT Introduction Child appropriate dosage forms are indispensable in modern medicine and are a prerequisite for successful pediatric drug therapy. For years, experts have called for a paradigm shift, from liquid dosage forms to novel oral solid dosage forms. This review aims to shed light on recent developments in Orodispersible tablets (ODTs) and mini-tablets (ODMTs). Areas covered This review focuses on the presentation and critical discussion of current challenges as well as recent advances in ODTs for pediatric drug delivery. Highlighted aspects are the evidence for acceptability by children, e.g. in comparison to other dosage forms, and limitations given by tablet size at different ages, as well as advances in special ODT formulations (taste masking, modified release, enabling formulations). Expert opinion It is the authors’ belief that OD(M)Ts have significant potential as dosage forms in pediatric therapy that has not yet been fully exploited. The reasons for this are, first, that the number of direct acceptance studies is extremely low and the resulting knowledge is therefore rather anecdotal. Despite the high relevance, there seems to be reluctance both in the therapeutic use and conduction of respective studies in children. However, if one combines the knowledge from the few existing studies, surveys, and from approved products, it becomes apparent that so far there is no evidence on limitations of the use of ODTs in pediatric patients.

Utilising Co-Axial Electrospinning as a Taste-Masking Technology for Paediatric Drug Delivery.

The present study describes the use of two taste-masking polymers to fabricate a formulation of chlorpheniramine maleate for paediatric administration. Co-axial electrospinning was utilized to create layered nanofibres; the two polymers, Eudragit® E PO and Kollicoat® Smartseal, were alternated between the core and the shell of the system in order to identify the optimum taste-masked formulation. The drug was loaded in the core on all occasions. It was found that the formulation with Kollicoat® Smartseal in the core with the drug, and Eudragit® E PO in the shell showed the most effective taste-masking compared to the other formulations. These fibres were in the nano-range and had smooth morphology as verified by scanning electron microscopy. Solid-state characterization and thermal analysis confirmed that amorphous solid dispersions were formed upon electrospinning. The Insent E-tongue was used to assess the taste-masking efficiency of the samples, and it was found that this formulation was undetectable by the bitter sensor, indicating successful taste-masking compared to the raw version of the drug. The E-tongue also confirmed the drug’s bitterness threshold as compared to quinine HCl dihydrate, a parameter that is useful for formulation design and taste-masking planning.

Advancements in Formulation Approaches to Pediatric Oral Drug Delivery systems

Designing and developing pediatric formulations is a challenging task as different patients have varied needs. Drug administration, flexibility, patient compliance, palatability, toxicity are the factors that are required to be considered during the development of pediatric preparations. To overcome the drawbacks of conventional drug delivery systems, the researchers have focused on various innovative methods such as novel drug delivery systems (NDDS). NDDS focuses on the formulation and development of pediatric formulations considering tolerability, efficacy and safety of active pharmaceutical ingredients and excipients.

Comparison of Four Methods of Paramedic Continuing Education in the Management of Pediatric Emergencies

Introduction: Finite resources limit the amount of time EMS agencies can dedicate to continuing education in pediatric emergencies. EMS instructors need effective, efficient, and affordable educational strategies for these high-risk, low frequency events. Objective: To compare the effectiveness of four training methods in management of pediatric emergencies for paramedics. Methods: A validated, performance-based, simulated clinical assessment module was used to provide a baseline measurement of paramedics’ resuscitation skills during three simulated pediatric emergencies. Educational modules were developed that targeted deficiencies identified by the baseline assessment, including advanced pediatric life support skills, airway management, use of the Broselow-Luten Tape®, pediatric drug dose calculations and drug delivery, seizure management, and trauma assessment. Paramedics from five EMS agencies in Michigan were randomized to four education intervention groups. The control group used an existing, online, continuing education course. Three experimental groups were exposed to the same content during five, one-hour sessions conducted over 2.5 years. Instruction was delivered using high-fidelity, simulated case-based training, low-fidelity simulation training, or lecture with procedural skills lab, based on group assignment. After the training, all groups were tested within 4–6 months using methods identical to baseline testing. Results: One hundred forty-seven subjects completed the study. There were no differences in baseline skill levels among the four groups. Only the low fidelity simulation training group demonstrated improvement of combined scenario scores (p = 0.0008). Scores for targeted skills improved in one scenario in the high-fidelity group, two in the low-fidelity group, one in the lecture/lab group, and none in the control group. Conclusions: Although improvements in those skills included in the training were found in three groups, two hours of training in pediatric emergencies per year was insufficient to produce a substantial improvement overall. Expensive, high-fidelity simulators were not necessary for teaching pediatric resuscitation skills to paramedics; instructive scenarios using low-fidelity manikins and debriefings appear to be adequate. The content delivered by an online refresher course did not provide any improvement in performance as measured by simulated, case-based assessments.

Regulatory Approval Scenario of Biosimilars in Pediatric Patients in the United States and European Union.

Regulatory agencies of the USA and European Union (EU) have introduced multiple guidelines in the last decade to standardize and accelerate biosimilar development. As a result, a large number of biosimilars are being approved in the USA and EU. In the present review, we identified the biosimilars and their corresponding reference biologics approved for pediatrics in the USA and EU, and then assessed their approval details. In the USA, a biosimilar applicant needs to submit an initial pediatric study plan under the Pediatric Research Equity Act (PREA). We found that the PREA requirements of a pediatric assessment for biosimilars were waived where the reference biologics were not approved for one or more pediatric age groups for an indication. The PREA requirements of a pediatric assessment were deferred if the indication was under orphan drug exclusivity or a pediatric formulation was not available. Excluding the waiver and deferral scenarios, biosimilars were approved for the same pediatric indications as those of the reference biologics based on scientific justification extrapolation from the pediatric information of the reference biologics to biosimilars. The applicants were asked to submit a pediatric assessment in the deferred indication and/or develop a dedicated formulation that can ensure accurate dose delivery in pediatric population, as applicable. In the EU, pediatric assessments were not required for biosimilars; hence, all biosimilars (except rituximab) have been approved for the same indications as those of the reference biologics. Biosimilar developers need to be aware of the possible requirement of a pediatric study plan, development of pediatric drug delivery devices, and requirement of human factor studies for a device, to avoid delay in approval of biosimilars in the USA.

Development of nanoparticle-based orodispersible palatable pediatric formulations

Despite a collaborative effort towards developing suitable oral drug products for pediatrics over the past decade, appropriate pediatric dosage forms have remained lacking due to special considerations in dose flexibility, swallowability, palatability, and safety of excipients for pediatrics. The present research aims to develop a nanoparticle-based orodispersible pediatric drug delivery platform to improve oral bioavailability and taste of poorly water-soluble and unpalatable therapeutics. Two Biopharmaceutics Classification System II/IV compounds lopinavir (LPV) and ritonavir (RTV) with unpleasant taste were chosen as the model compounds. LPV and RTV Eudragit® E PO nanoparticles (NP) were prepared using a nanoprecipitation method and their key quality attributes and taste-masking effect were evaluated. Moreover, in vitro dissolution testing was conducted at simulated gastrointestinal pH conditions. The in vivo bioavailability of the developed NP formulations was assessed using a rat model. Following the formulation optimization, over 98% encapsulation efficiency was obtained for both LPV and RTV NP and both drugs remained amorphous in its respective NP. LPV/RTV NP combination (4/1, w/w) showed comparable in vitro dissolution to that of the commercial LPV/RTV tablet (Kaletra®). In addition, the taste-masking effect of the developed NP formulations was confirmed by an E-tongue study. The lyophilized LPV and RTV NP were completely dispersible in water within 7 sec and remained stable at 4 ± 2 °C over three months. Lastly, the pharmacokinetic study demonstrated that the LPV/RTV NP combination (4/1, w/w) had improved oral bioavailability compared to Kaletra® and their corresponding raw drug powders. The results demonstrated a novel nanoparticle-based orodispersible platform that is capable of improving oral bioavailability and taste of poorly water-soluble and unpalatable therapeutics for pediatric use.

The rectal route of medicine administration for children: Let’s get to the bottom of it!

AimsResearch around paediatric rectal drug delivery has previously been based on views of parents and healthcare workers. The aim of this exploratory study was to gauge whether children and young adults in the UK were comfortable with the idea of rectal drug delivery. MethodsEleven children from a pre-existing patient and public advisory group were involved in the session. Rectal drug delivery was explained and group participants were asked a series of questions. Responses were discussed in a group and recorded individually. ResultsOf the group, 27% would consider the rectal route, while 64% said it depended on other options available. The primary concern focused on potential for abusive misuse by others. Participants thought this would be overcome if the child could self-administer, although there was also concern about the process of self-administration. ConclusionsNot all children in the UK are against rectal drug delivery, but education is needed to teach children to self-administer medication in this way.

A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films with Potential for Paediatric and Geriatric Drug Delivery.

Orally dissolving films (ODFs) have received much attention as potential oral drug delivery systems for paediatric and geriatric patients, particularly those suffering from dysphagia. With their unique properties and advantages, the technology offers improved patient compliance and wider acceptability, eliminates the fear of choking, enables ease of administration and offers dosing convenience, without the requirement of water. However, adequate drug loading remains a challenge. The aim of this study was to mechanistically design and evaluate fast and extended release ODF formulations with high drug loading capacity, displaying good physicochemical and mechanical properties, as a potential dosage form for paediatric and geriatric use employing a slightly soluble model drug-ibuprofen. Different polymers (0.6-10% HPMC, 0.6-1.5% guar gum), plasticisers (0.1-0.5% glycerine, 0.1% sorbitol) and processing conditions (40-60°C drying temperatures, 8-16h drying times) were investigated to produce films using the solvent casting method. Molecular compatibility was assessed using TGA, XRD and FTIR whereas film topography was assessed using SEM. Maximum ibuprofen load in single films was 20.7mg/film (54.4%) and released 100% drug content in 5min, while triple layered ibuprofen-loaded films contained 62.2mg/film and released 100% drug release in 1h. The ODFs demonstrated good disintegration time using low volume artificial saliva media and high dosage from uniformity. This study provides a mechanistic insight to the design and evaluation of fast and extended release ODFs with high drug loading, suitable for administration to paediatric and geriatricpatients.

Mini Tablets: Pediatric Drug Delivery System

Mini tablets constitute a solid dosage form and are more than one-unit dosage, they are advantageous than pellets or another oral dosage forms and greater when given to children and elderly human beings as they may be at ease to swallow. Amongst all MUDFs, mini tablets provide several benefits like they do not require any solvent for their manufacturing, can be coated reproducibly, and also requires much less coating material. Additionally, there's a brilliant flexibility during their formulation development. Dose dumping and local infection may be prevented with the aid of the use of mini tablets. Child differs from grown-up in pharmacotherapy, together with abilities for drug administration, medication-related toxicity, and taste preference. It is vital that pediatric medicines are formulated to foremost acceptable with child's age, size, physiologic conditions remedy requirements development are important and the research of latest methods to deliver drugs tends to enhance compliance, convenience and pharmacokinetic. Further, recommended that small sized solid dosage forms or orally disintegrating stable dosage forms have to be preferred. Their small size permits them to be nicely distributed alongside the gastrointestinal tract enhancing the bioavailability even as decreasing region drug attention, risk of toxicity and side effects.

Bioadhesive Food Protein Nanoparticles as Pediatric Oral Drug Delivery System.

The goal of this study was to develop bioadhesive food protein nanoparticles using zein (Z), a hydrophobic corn protein, as the core and whey protein (WP) as the shell for oral pediatric drug delivery applications. Lopinavir (LPV), an antiretroviral drug, and fenretinide, an investigational anticancer agent, were used as model drugs in the study. The particle size of ZWP nanoparticles was in the range of 200-250 nm, and the drug encapsulation efficiency was >70%. The nanoparticles showed sustained drug release in simulated gastrointestinal fluids. ZWP nanoparticles enhanced the permeability of LPV and fenretinide across Caco-2 cell monolayers. In both ex vivo and in vivo studies, ZWP nanoparticles were found to be strongly bioadhesive. ZWP nanoparticles enhanced the oral bioavailability of LPV and fenretinide by 4 and 7-fold, respectively. ZWP nanoparticles also significantly increased the half-life of both drugs. The nanoparticles did not show any immunogenicity in mice. Overall, the study demonstrates the feasibility of developing safe and effective food protein-based nanoparticles for pediatric oral drug delivery.

Oral Drug Delivery System Challenges to Pediatrics and Current Approaches

The focus of present study is to exhibit novel methods for pediatric oral drug delivery. To overcome the problems associated with drug administration, toxicity and taste preference the drug designed in such way that it best suits to child age, required treatment, size and physiological condition. Pediatrics differs from adult in many aspects of pharmacotherapy. Palatability is the biggest challenge while designing the pediatric formulation. As the vast no of limitation present in solid formulation there is wide scope in novel research in designing the pediatrics drug delivery system. Novel approaches in oral drug delivery system is somewhat satisfy the challenges but not the give proper solution. To overcome these problems the novel innovative researches is going on. The formulation should be designed in such a way that is easy to administer for pediatrics, having dose flexibility and better palatability of drug formulation.