Effects of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: A systematic literature review

Riet‐Nales, Diana A. van; Schobben, A. F. A. M.; Egberts, Toine C. G.; Rademaker, Carin M. A.

doi:10.1016/j.clinthera.2010.05.005

Cited by 28 publications

(14 citation statements)

References 106 publications

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“…[128][129][130] Fourth, ongoing technologic advances need to be accompanied by relevant patient outcome studies and clinical feedback on efficacy, safety, patient acceptability, preferences, and adherence regarding new formulations; currently, such studies and feedback are lacking. 131 Practice-based evidence on the impact of novel formulations, generated by health care professionals and caregivers, could provide further support for the development of pediatric medicines with clear clinical advantages.…”

Section: Future Stepsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

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Section: Future Stepsmentioning

confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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“…Many patients experience difficulty with taking medication because of aversion to the taste, which results in suboptimal adherence. Although there are no easy solutions to this dilemma, pharmaceutical companies have tried to improve palatability by adding flavors to medications, such as vanilla, strawberry, and citrus 15–17…”

Section: Discussionmentioning

confidence: 99%

“…Several studies have addressed the palatability of medication for different disorders, including hypertension, HIV, and Alzheimer’s disease 12–14. Pharmaceutical companies have tried to improve palatability by adding flavors, such as vanilla, strawberry, and citrus, although this is primarily in medication for children 15–17…”

Section: Introductionmentioning

confidence: 99%

Differences in taste between three polyethylene glycol preparations: a randomized double-blind study

Lam

Mulder²,

Felt‐Bersma³

2011

PPA

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Background and aimPatients suffering from chronic constipation require long-term, regular therapy with laxatives. Literature regarding patient preference and acceptance in polyethylene glycol preparations is scarce. Therefore, this research aimed to identify preference between the three polyethylene glycol 3350, namely Molaxole®, Movicol®, and Laxtra Orange®. Furthermore, taste is one of the most important factors leading to patients’ adherence, particularly when the treatment lasts for a long time.MethodsIn this randomized, cross-over double-blind study, 100 volunteers were recruited by advertisement. The volunteers were invited to taste the preparations and grade the taste using a five-point hedonic scale (extremely poor taste [1] to extremely good taste [5]). The volunteers were then asked to choose the most palatable preparation.ResultsOne hundred volunteers with a mean age of 35 years (range 20–61) were randomized (76 females). Molaxole®, Movicol®, and Laxtra Orange® had a mean hedonic score of 2.76 (SD: 0.82), 2.81 (SD: 0.76) and 3.12 (SD: 0.82) respectively. The hedonic taste score for Laxtra Orange® was significantly better than Molaxole® (P = 0.001) and Movicol® (P = 0.001). No difference was found between Molaxole® and Movicol® (P = 0.61). Molaxole® was the most preferred preparation for 19 volunteers (19%), Movicol® for 24 volunteers (25%) and Laxtra Orange® for 55 volunteers (56%). Two volunteers had no preference. The order in which volunteers tested the preparations had no influence on the taste results. No significant differences in age or gender were observed.ConclusionLaxtra Orange® was most palatable preparation. This may have implications for adherence in patients with chronic constipation.

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“…Acknowledging that information on the pharmaceutical design of paediatric drugs in relation to patient outcomes was scarce and fragmented, the Paediatric Regulation has triggered a variety of research opportunities (12,13). In addition, several research consortia were established, e.g.…”

Section: Better Medicines For Childrenmentioning

confidence: 99%

Paediatric Drug Development and Formulation Design—a European Perspective

Riet‐Nales

Kozarewicz²,

Aylward

et al. 2016

AAPS PharmSciTech

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Abstract.The availability of licensed paediatric drugs is lagging behind those for adults, and there is a lack of safe formulations in suitable doses that children are able and willing to take. As a consequence, children are commonly treated with off-label or unlicensed drugs. As off-label and unlicensed drug use are associated with a greater risk for harm than on-label drug use, a range of global initiatives have been developed to realize Bbetter^medicines for children. This review describes the challenges and achievements of the European Union to realize this goal, with a focus on paediatric drug development and formulation design. In 2007, a European Paediatric Regulation was installed enforcing companies to consider children in the early development of drugs with a new drug substance, for a new indication or with a new route of administration. The Regulation, e.g. requires companies to develop a paediatric investigation plan discussing the proposed clinical trials in children of different ages and the formulations for future marketing. Since 2013, the pharmaceutical design of any newly marketed paediatric drug should comply with the BGuideline on the Pharmaceutical Development of Medicines for Paediatric Use.^Companies should, e.g. justify the route of administration, dosage form, formulation characteristics, safety of excipients, dosing frequency, container closure system, administration device, patient acceptability and user information. In this review, the guideline's key aspects are discussed with a focus on novel formulations such as mini-tablets and orodispersible films, excipients with a potential risk for harm such as azo dyes and adequate user instructions.

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Effects of the pharmaceutical technologic aspects of oral pediatric drugs on patient-related outcomes: A systematic literature review

Cited by 28 publications

References 106 publications

Pediatric Drug Formulations: A Review of Challenges and Progress

Pediatric Drug Formulations: A Review of Challenges and Progress

Differences in taste between three polyethylene glycol preparations: a randomized double-blind study

Paediatric Drug Development and Formulation Design—a European Perspective

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