Abstract
AbstractMedicine co-administration with food or drink vehicles is a common administration practice in paediatrics. The aims of this review were (i) to describe the current recommended strategies for co-administration of paediatric medicines with food and drinks (vehicles); (ii) to compare current administration recommendations from different countries; and (iii) to obtain a global perspective on the rationale behind the choice of recommended vehicle, in the context of the physicochemical properties of the drug and formulation. This study used a defined search strategy on the practices of paediatric medicine co-administration with vehicles, recommended in a commonly used paediatric and neonatal handbook, in addition to the information previously gathered from UK formularies. Logistic regression analysis was performed to further understand the biopharmaceutical basis of the choice of recommended vehicle for medicine co-administration. Differences were identified in the type of vehicles globally recommended for medicine co-administration. Ultimately, a statistical model was developed which provided an understanding on which vehicle is recommended for use with drugs/formulations, with basis on their biopharmaceutical properties. Overall, this review highlights the areas where further information is needed to support standardised procedures and guide the recommendation of age-appropriate and acceptable vehicles for use in the co-administration of paediatric medicines. Unified requirements are needed for harmonisation of the practice of medicine co-administration with vehicles. In vitro and/or in silico tools should be developed to evaluate the potential clinical outcomes of this practice during paediatric drug development.
Publisher
Springer Science and Business Media LLC
Reference48 articles.
1. Strickley RG, Iwata Q, Wu S, Dahl TC. Pediatric drugs - a review of commercially available oral formulations. J Pharm Sci. 2008;97(5):1731–74.
2. Ernest TB, Elder DP, Martini LG, Roberts M, Ford JL. Developing paediatric medicines: identifying the needs and recognizing the challenges. J Pharm Pharmacol. 2007;59(8):1043–55.
3. Ivanovska V, Rademaker CM, van Dijk L, Mantel-Teeuwisse AK. Pediatric drug formulations: a review of challenges and progress. Pediatrics. 2014;134(2):361–72.
4. Turner MA, Catapano M, Hirschfeld S, Giaquinto C. Paediatric drug development: the impact of evolving regulations. Adv Drug Deliv Rev. 2014;73:2–13.
5. World Health Organization: Development of paediatric medicines: points to consider in pharmaceutical development (Working document QAS/08.257/Rev.3). 2011. http://www.who.int/medicines/areas/quality_safety/quality_assurance/Rev3-PaediatricMedicinesDevelopment_QAS08-257Rev3_17082011.pdf . Accessed 21 January 2016.
Cited by
13 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献