Neonatal and pediatric oral drug delivery: Hopes and hurdles

Mfoafo, Kwadwo; Omidian, Masoud; Bertol, Charise Dallazem; Omidi, Yadollah; Omidian, Hossein

doi:10.1016/j.ijpharm.2021.120296

Cited by 29 publications

(26 citation statements)

References 81 publications

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“…More than 80% of the studied drugs possess a commercial authorization in oral forms in both EMA and FDA, and around 50% of these formulations are not age-appropriate for most pediatric groups [ 29 ]. In this study, biological products were mainly injection; and nearly 50% of the chemical compound drugs were tablets and injections, and oral solution, syrup, granules account for nearly 20%, development of dosage forms suitable for children is another current challenge, especially for neonates, which have long been neglected concerning the development of oral dosage forms [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

et al. 2022

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Background Research and development of pediatric drug faces many difficulties and pediatric clinical trials remain a challenge. Since 2011, a series of measures have been taken to encourage research, development of drugs for pediatric patients in China. In this study, we analyzed pediatric clinical trials conducted in China to provide reference for research and development of pediatric drugs and formulation of relevant policies. Methods We conducted a cross-sectional observational study of pediatric trials registered in the Drug Trial Registration and Information Publication Platform before Oct. 31, 2021. All trials that recruited children (under 18 years old as defined in China) were retrieved and general characteristics of the trials and the research drugs were extracted and analyzed. The data were extracted and statistically analyzed by excel 2010 and SPSS 22.0, respectively. Results There were 588 registered pediatric clinical trials, which accounted for 3.94% of the total registered trials. The overall average annual growth rate of the number of trials from 2013 to 2020 was 14.47% (P < 0.01). Of the 588 trials included, there were 312 trials (53.06%) with only children as subjects, 127 trials (21.60%) with research drugs only for children use, and the median of target subject number was 320 with the range of 8 to 600,000. The sponsors and the principal investigators were mainly located in the eastern and northern China. 325 trials were vaccine trials, and the dosage form was mainly injection. There were 98 non-vaccine biological product trials (mainly injections), 135 chemical compound drug trials (mainly tablets), 30 traditional Chinese medicine/natural drugs (mainly granules). Indications of the non-vaccine drugs were mainly diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. Conclusion The number of pediatric clinical trials in China has increased these years. To further promote pediatric clinical trials and motivate pediatric appropriate drug marketing application and administrative approval, conducting large pediatric clinical trials, further development of dosage forms suitable for children with special attention to neonates and prematurity, and improving uneven geographical distribution of sponsors and researchers are the current challenges.

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Section: Discussionmentioning

confidence: 99%

Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

et al. 2022

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“…Unfortunately, since they are often judged as being poorly palatable, they are usually added to food or drink by caregivers, even when such practice is not recommended in the leaflet. Pellets, being a flexible multiunit dosage form, could also be of interest in the development of pediatric formulations, however, they require solvent before extrusion and spheronization and are more suitable when controlled release of the drug is desired [40]. The main issues and concerns regarding the use of the most common pediatric solid and liquid dosage forms are summarized in Figure 4.…”

Section: Appropriate Medications For Pediatrics: the Paradigm Shift T...mentioning

confidence: 99%

Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics

et al. 2022

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In the treatment of pediatric diseases, mass-produced dosage forms are often not suitable for children. Commercially available medicines are commonly manipulated and mixed with food by caregivers at home, or extemporaneous medications are routinely compounded in the hospital pharmacies to treat hospitalized children. Despite considerable efforts by regulatory agencies, the pediatric population is still exposed to questionable and potentially harmful practices. When designing medicines for children, the ability to fine-tune the dosage while ensuring the safety of the ingredients is of paramount importance. For these purposes solid formulations may represent a valid alternative to liquid formulations for their simpler formula and more stability, and, to overcome the problem of swelling ability, mini-tablets could be a practicable option. This review deals with the different approaches that may be applied to develop mini-tablets intended for pediatrics with a focus on the safety of excipients. Alongside the conventional method of compression, 3D printing appeared particularly appealing, as it allows to reduce the number of ingredients and to avoid both the mixing of powders and intermediate steps such as granulation. Therefore, this technique could be well adaptable to the daily galenic preparations of a hospital pharmacy, thus leading to a reduction of the common practice of off-label preparations.

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“…Clearly defined international criteria to determine whether or not a formulation is acceptable for children are unavailable. Manufacturing technologies and technical processes behind oral drug delivery platforms have been recently reviewed 26,27 and will not be addressed in this paper.…”

Section: Paediatric Oral Dosage Forms: Where Do We Stand?mentioning

confidence: 99%

From paediatric formulations development to access: Advances made and remaining challenges

Litalien

Bérubé

Tuleu

et al. 2022

Brit J Clinical Pharma

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Developing suitable paediatric formulations and ensuring access to them by the greatest number of the 2.2 billion children worldwide are equally important to provide optimal pharmacotherapy. This review focuses on the progress made over the last two decades with paediatric oral formulations with respect to evidence for acceptability and dosing flexibility of liquid and solid oral dosage forms. It also discusses the clinical needs for, and the access to, paediatric formulations for existing authorised medicines. A significant body of new knowledge now supports the acceptability of solid oral dosage forms in children, resulting in an increasing number of medicines commercialised as multiparticulates, including minitablets that are starting to be brought to market. However, there are gaps with these formulations that deserve more research. Even though efforts have been made to identify medicines in need of age-appropriate formulations, there is no common priority list shared internationally. Such prioritisation would help to develop paediatric formulations with the greatest potential for providing a health benefit to children worldwide. In addition, available data highlight that paediatric formulation access is fragmented and unequal, with commercialisation of suitable paediatric formulations too often limited to some countries/regions. We propose actions to better align decisions during the development of paediatric formulations and promote a more globalised approach to facilitate registration pathways between different jurisdictions. Furthermore, discussions about alignment between approval, pricing and reimbursement processes should also happen, leaving working in siloes behind us. It is time for adults to start thinking outside the box for children.

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Neonatal and pediatric oral drug delivery: Hopes and hurdles

Cited by 29 publications

References 81 publications

Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval

Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics

From paediatric formulations development to access: Advances made and remaining challenges

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