<b>Development and evaluation of age-appropriate film-coated tablets of levamisole for paediatric use (2 – 18 years)</b>

Kreeftmeijer-Vegter, Annemarie Rosan; Meijer, Mariska de; Wegman, Kim A M; Veldhuizen, Cees K W van

doi:10.1517/17425247.2013.745849

Cited by 19 publications

(21 citation statements)

References 15 publications

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“…Tablets up to 8 mm in diameter were demonstrated to be acceptable (able to be swallowed whole) in children as young as 2 years of age . The number of tablets that could be swallowed was only investigated for the minitablets, where Kluk et al .…”

Section: Resultsmentioning

confidence: 99%

“…Tablets up to 8 mm in diameter were demonstrated to be acceptable (able to be swallowed whole) in children as young as 2 years of age. [16,21,22] The number of tablets that could be swallowed was only investigated for the minitablets, where Kluk et al [15] demonstrated that up to 10 minitablets were acceptable to children from 2 years of age when they were suspended in jelly to aid administration. About 58% of children aged 2-3 were able to swallow 10 minitablets without chewing; many other children chewed the tablets, which may limit their use to palatable immediate release formulations.…”

Section: Monolithic Solid Dosage Formsmentioning

confidence: 99%

“…In a 2 face hedonic, these were considered as acceptable or not; in the 4 face hedonic, this was also the case for the negative two being unacceptable and positive 2 being acceptable [10] Carers needed to state that the product was equally or more acceptable to their child than other medicines (70% of population agreeing was used as basis for statistical powering) [11] Two products were included that were stated to be acceptable and unacceptable in terms of taste using a 5 point hedonic scale from 1 worst to 5 best [12] Acceptable taste = mean score of 3.4 in a five-point hedonic scale Unacceptable taste = mean score of 2.1 in a five-point hedonic scale Primary endpoint (of acceptability) was % of participants with a score of >4 on the seven-point hedonic scale [13] Ability to swallow the dosage form whole (observed to look for chewing, choking, aspiration) [14][15][16][17][18][19] 2 mm [23] 82.2% can swallow 2 mm [23] 0.5 2 mm [14,17] 70% can swallow 2 mm [17] 1 4 m m [24] 60% can swallow 2 mm [17]…”

Section: Study Referencementioning

confidence: 99%

“…2 -3 mm [15] 40% can swallow 2 mm [17] 60% can swallow 2-3 mm [15] 46% can swallow 3 mm [18] >80% can swallow 5 mm [16] Can be trained to swallow tablets up to 7-8 mm [16] 3 50% can swallow 2 mm [17] 53% can swallow 3 mm [18] >80% can swallow 17.6 mm (size 2 capsule) [20]…”

Section: Study Referencementioning

confidence: 99%

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Evidence of acceptability of oral paediatric medicines: a review

Mistry

Batchelor

2017

Journal of Pharmacy and Pharmacology

125

109

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Objectives The aim of this review was to map the currently available evidence on acceptability of oral paediatric medicines to aid in the selection of suitable platform formulations for the development of new acceptable paediatric products. Methods This process used a defined search strategy of indexed publications and included methods to assess the quality of the evidence retrieved. Key findings Taste/palatability was the most extensively studied area of paediatric medicine acceptability yet standard methods or criteria that define what is classed as acceptable to children is still to be defined. There have been many reports on the acceptability of medicines to paediatric populations yet major gaps in the acceptability knowledge base exist including the shape and dimensions of tablets, minitablets and capsules swallowed whole in infants and children; size and overall volume of multiparticulates; volume of liquids completely swallowed in infants and children; duration of retention within the oral cavity, size and taste of orodispersible tablets, lozenges and chewable tablets and the number of solid units dosed at each time point. Conclusions The review highlights where further information is required to support knowledge around acceptability of age-appropriate medicines. An algorithm to aid in selection of a formulation that is likely to be acceptable based on the age range to be treated by the medicine is presented as a result of this review. IntroductionThere is much evidence to support the need for age-appropriate medicines to treat paediatric patients. Pharmaceutical products for the paediatric population have a number of considerations that may not apply to adult products. In particular, the acceptability of a product needs to be clearly defined for paediatric populations and this is currently an area of great interest.The importance and incentive to study the acceptability, including palatability, of paediatric formulations was discussed in the reflection paper [1] and endorsed in the latest European Paediatric guideline on pharmaceutical development of formulations for paediatric use.[2] Before this regulatory change, there was no requirement for medicines to be demonstrated to be acceptable to children. Guidance issued by the European Medicines Agency (EMA) in 2013 states that patient acceptability must be an integral part of paediatric formulation development and described in the paediatric investigation plan (PIP).[3] Acceptability has previously been defined as 'an overall ability of the patient and caregiver (defined as "user") to use a medicinal product as intended (or authorised)'.[4] The palatability of paediatric medicines is one of the most important formulation factors in the acceptability of liquid medicines with potential to influence adherence to therapeutic regimens and outcomes.[5] Palatability has been defined as, 'the overall appreciation of a (often oral) medicine by organoleptic properties such as vision (appearance), smell, taste, aftertaste and mouth feel (e.g. texture, cooli...

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Section: Resultsmentioning

confidence: 99%

Section: Monolithic Solid Dosage Formsmentioning

confidence: 99%

Section: Study Referencementioning

confidence: 99%

Section: Study Referencementioning

confidence: 99%

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Evidence of acceptability of oral paediatric medicines: a review

Mistry

Batchelor

2017

Journal of Pharmacy and Pharmacology

125

109

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“…Generally levamisole is administered as a liquid that has the disadvantage of a bitter taste and is not available in every country. The development of an oral solid dosage form of levamisole suitable for the pediatric population should be followed by new trials in this field [86].…”

Section: Levamisolementioning

confidence: 99%

Treatment of children with frequently relapsing steroid-sensitive nephrotic syndrome: recent trial results

Benz¹,

Toenshoff²,

Weber³

2014

Clinical Investigation

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Despite being an orphan disease idiopathic nephrotic syndrome in children is the most frequent glomerular disease in this age group. A total of 80-90% of children between 2 and 10 years of age respond to corticosteroids, but carry the risk of relapses that may even appear frequently (frequently relapsing nephrotic syndrome, [FRNS]). To avoid repeated courses of corticosteroids and associated drug toxicity in these patients manifold strategies for a corticosteroid-sparing treatment of FRNS exist, but evidence on their efficacy and safety is low. This article discusses the results of recent therapeutic trials on FRNS and their possible impact on existing guidelines. Since the prognosis of steroid-sensitive nephrotic syndrome toward renal function is generally good, not only the efficacy but also the toxicity of different treatment regimens is discussed.

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Development and evaluation of an assessment of the age-appropriateness/inappropriateness of formulations used in children

et al. 2022

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Background Medicines designed for adults may be inappropriate for use in children in terms of strength, dosage form and/or excipient content. There is currently no standardised method of assessing the age-appropriateness of a medicine for paediatric use. Aim To develop and test a tool to assess whether a dosage form (formulation) is appropriate for children and estimate the proportion of formulations considered ‘inappropriate’ in a cohort of hospitalised paediatric patients with a chronic illness. Method A multi-phase study: patient data collection, tool development, case assessments and tool validation. Inpatients aged 0–17 years at two UK paediatric/neonatal hospitals during data collection periods between January 2015 and March 2016. Written informed consent/assent was obtained. Medicines assessed were new or regularly prescribed to inpatients as part of their routine clinical care. All medicine administration episodes recorded were assessed using the Age-appropriate Formulation tool. The tool was developed by a consensus approach, as a one-page flowchart. Independent case assessments were evaluated in 2019. Results In 427 eligible children; 2,199 medicine administration episodes were recorded. Two assessors reviewed 220 episodes in parallel: percentage exact agreement was found to be 91.7% (99/108) and 93.1% (95/102). In total, 259/2,199 (11.8%) medicine administration episodes involved a dosage form categorised as ‘age-inappropriate’. Conclusion A novel tool has been developed and internally validated. The tool can identify which medicines would benefit from development of an improved paediatric formulation. It has shown high inter-rater reliability between users. External validation is needed to further assess the tool’s utility in different settings.

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Development and evaluation of age-appropriate film-coated tablets of levamisole for paediatric use (2 – 18 years)

Abstract: The formulated tablets were found to be suitable for children aged 2 - 18 years and to provide good dose accuracy.

Cited by 19 publications

References 15 publications

Evidence of acceptability of oral paediatric medicines: a review

Evidence of acceptability of oral paediatric medicines: a review

Treatment of children with frequently relapsing steroid-sensitive nephrotic syndrome: recent trial results

Development and evaluation of an assessment of the age-appropriateness/inappropriateness of formulations used in children

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