Challenges of developing palatable oral paediatric formulations

Cram, Anne; Breitkreutz, Jörg; Desset-Brèthes, Sabine; Nunn, Tony; Tuleu, Catherine

doi:10.1016/j.ijpharm.2008.09.015

Cited by 120 publications

(57 citation statements)

References 4 publications

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“…Les recommandations de l'EMA, selon lesquelles ce volume ne devrait pas excéder 5 mL chez l'enfant de moins de 5 ans et 10 mL au-delà, sont difficiles à respecter [3]. D'autre part, de nombreux principes actifs ont un goût amer difficile à masquer dans une formulation liquide [11]. L'acceptabilité du goût d'une FOL par l'enfant, très différente de celle de l'adulte et largement dépendante des habitudes culturelles, est difficile à évaluer en raison du manque de références et d'échelles de mesures validées [2,12].…”

Section: Forme Orale Liquideunclassified

Choisir la forme pharmaceutique orale la plus adaptée à l’enfant

Lajoinie

Hénin

Kassai

2015

Archives de Pédiatrie

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Section: Forme Orale Liquideunclassified

Choisir la forme pharmaceutique orale la plus adaptée à l’enfant

Lajoinie

Hénin

Kassai

2015

Archives de Pédiatrie

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“…Compliance and concordance issues have multivariate complex origins but an unacceptable taste is one major compliance issue (Cram et al 2009). Two factors make taste preference and palatability critical in paediatric adherence.…”

Section: Compliance Issuesmentioning

confidence: 99%

Drug Delivery and Formulations

Breitkreutz

Boos

2011

Pediatric Clinical Pharmacology

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Paediatric drug delivery is a major challenge in drug development. Because of the heterogeneous nature of the patient group, ranging from newborns to adolescents, there is a need to use appropriate excipients, drug dosage forms and delivery devices for different age groups. So far, there is a lack of suitable and safe drug formulations for children, especially for the very young and seriously ill patients. The new EU legislation will enforce paediatric clinical trials and drug development. Current advances in paediatric drug delivery include interesting new concepts such as fast-dissolving drug formulations, including orodispersible tablets and oral thin strips (buccal wafers), and multiparticulate dosage forms based on mini-tabletting or pelletization technologies. Parenteral administration is likely to remain the first choice for children in the neonatal period and for emergency cases. Alternative routes of administration include transdermal, pulmonary and nasal drug delivery systems. A few products are already available on the market, but others still need further investigations and clinical proof of concept.

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“…The abilities of taste masking of API in medicinal formulations depend almost exclusively on the type of formulation (solid or liquid). While taste masking is relatively simple for the solid dosage forms (such as tablets), where any kind of protective coating solves the problem, masking in liquid dosage forms (such as suspensions) is much more complicated [3].…”

Section: Introductionmentioning

confidence: 99%

“…Oral liquid dosage forms are formulations of choice in pediatric use [3,4]. Most of commercial liquid formulations contain artificial sweeteners (saccharin and aspartame) and flavor mixes to mask the taste.…”

Section: Introductionmentioning

confidence: 99%

“…Well-established statistical methods remove possibilities of errors and variability between volunteers. Studies on pediatric formulations should not be performed on mature volunteers due to too large physiological differences of taste sensation [2,3]. Ethical doubts on experiments in children and difficulties with interpretation of the results caused by unequal growth of children with the same age, indicate the need to use in vitro/in silico methods for taste evaluation [3].…”

Section: Introductionmentioning

confidence: 99%

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