European Paediatric Formulation Initiative workshop report: Improving the administration of oral liquid medicines in paediatrics using dosing syringes and enteral accessories

Walsh, Jennifer; Riet–Nales, Diana van; Hermans, Esmerald; Vries, Rutger de; Hilton, Gareth; Blowers, Paul; Salunke, Smita

doi:10.1016/j.ejpb.2020.04.007

Cited by 12 publications

(8 citation statements)

References 22 publications

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“…Accurate dosing of the right medicine to the right patient is a key element of safe and efficacious pharmacotherapy, yet prone to technical challenges and human error when dosing involves the administration of a small volume of liquid medicineene. [ 52 ] Dare et al conducted a study to increase the supply of vaccines to prevent the transmission of covids with low dead volume syringes and needles to determine which medical devices allow extraction of doses from different vaccine vials (Pfizer-BioNTech, AstraZeneca, Moderna, and Johnson & Johnson Vaccine). According to his study, syringe accuracy is important and can compromise the chance of extracting additional doses when withdrawing too large a volume.…”

Section: Resultsmentioning

confidence: 99%

The hypodermic syringe performance based on the ISO 7886-1:2017: A narrative review

et al. 2022

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A syringe is used to inject fluid or medicine into the patient's soft tissue. The main components of the syringe were the needle, barrel, and plunger. The use of syringes in the medical world is relatively high, and especially since the COVID-19 pandemic, the use of hypodermic syringes increased sharply due to vaccination. The syringe used must be effective and of good quality, so the International Organization for Standardization (ISO) has published test procedures and minimum specifications for hypodermic syringes. The performance of the syringe can be observed from the dead space, force piston operation, water and air leakage, and fitting position of the plunger in the barrel. This review shows that most researchers use the weighing method to measure the dead space, although some use other methods. The researchers found that most of the products met the minimum specifications of the ISO, and that the dimensions and shape of the syringe affected the dead space. Researchers have not examined other performance measures recommended by the ISO. Researchers have focused more on force injection than force piston operation, leakage after injection or back spray than air and water leakage, and reduction the friction of the plunger without considering the fitting position of the plunger in the barrel.

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Section: Resultsmentioning

confidence: 99%

The hypodermic syringe performance based on the ISO 7886-1:2017: A narrative review

et al. 2022

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“…As for the minimum recommended volume, there is no clear guidance but it depends on the accuracy of measuring devices, and factors such as dead space during administration 17 . During a workshop organised by the EuPFI in 2018, many challenges associated with the correct oral dosing of small liquid volumes were identified along with potential solutions 29 …”

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

confidence: 99%

“…17 During a workshop organised by the EuPFI in 2018, many challenges associated with the correct oral dosing of small liquid volumes were identified along with potential solutions. 29 For some medicines such as bitter-tasting medicines, a major drawback of liquid formulations is their inability to achieve an acceptable taste, limiting their acceptability in children. An unpleasant taste can affect the ease of administration and influence compliance, and as a consequence effectiveness.…”

Section: Liquid Oral Dosage Formsmentioning

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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“…It is therefore recommended that the concentration of an oral liquid medicine should allow accurate administration of the required doses and the maximum capacity (size) of a measuring device should be appropriate for the volume to be dosed [63]. It is necessary for the innovator to evaluate and confirm the compatibility, dosing accuracy and usability of a co-packaged administration device with the drug product, although in practice it may not be used by hospitalbased healthcare professionals [64].…”

Section: Administration Devicesmentioning

confidence: 99%

Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper

Walsh¹,

Schaufelberger

Iurian

et al. 2021

Brit J Clinical Pharma

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Improved global access to novel age-appropriate formulations for paediatric subsets, either of new chemical entities or existing drugs, is a priority to ensure that medicines meet the needs of these patients. However, despite regulatory incentives, the introduction to the market of paediatric formulations still lags behind adult products. This is mainly caused by additional complexities associated with the development of acceptable age-appropriate paediatric medicines. This position paper recommends the use of a paediatric Quality Target Product Profile (pQTPP) as an efficient tool to facilitate early planning and decision making across all teams involved in paediatric formulation development during the children-centric formulation design for new chemical entities, or to repurpose/reformulate off-patent drugs. Essential key attributes of a paediatric formulation are suggested and described. Moreover, greater collaboration between formulation experts and clinical colleagues, including healthcare professionals, is advocated to lead to safe and effective, age-appropriate medicinal products. Acceptability testing should be a secondary endpoint in paediatric clinical trials to ensure postmarketing adherence is not compromised by a lack of acceptability. Not knowing the indications and the related age groups and potential dosing regimens early enough is still a major hurdle for efficient paediatric formulation development; however the proposed pQTPP could be a valuable collaborative tool for planning and decision making to expedite paediatric product development, particularly for those with limited experience in developing a paediatric product.

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European Paediatric Formulation Initiative workshop report: Improving the administration of oral liquid medicines in paediatrics using dosing syringes and enteral accessories

Cited by 12 publications

References 22 publications

The hypodermic syringe performance based on the ISO 7886-1:2017: A narrative review

The hypodermic syringe performance based on the ISO 7886-1:2017: A narrative review

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

Path towards efficient paediatric formulation development based on partnering with clinical pharmacologists and clinicians, a conect4children expert group white paper

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