Recommended strategies for the oral administration of paediatric medicines with food and drinks in the context of their biopharmaceutical properties: a review

Abstract

Objectives This review focuses on the recommended strategies for the oral administration of paediatric medicines with food in the context of their biopharmaceutical properties. Key findings Acceptability of oral medicines in young patients is more challenging than in adult patients. Mixing oral dosage forms with foods and drinks is sometimes suggested to administer a specific dose and enhance compliance in the paediatric population. In this review, the strategies for the co-administration of paediatric medicines with food and drinks are discussed. Current administration practices as reported by healthcare professionals and parents/carers are compared with the relevant guidelines. Differences in the type of vehicles recommended to be used and actually used in current practice were identified. Correlations of the type of food recommended, the type of formulation and the drug's biopharmaceutical classification system (BCS) class were performed and revealed that recommendations should be made on a case-by-case basis. Summary The propensity for physiochemical or bioavailability changes that may occur from the co-administration of medicines with food and drinks in the paediatric population should be considered, and harmonisation of the recommended administration strategies is needed.

Co-administration of Paediatric Medicines with Food and Drinks in the Context of Their Physicochemical Properties—a Global Perspective on Practices and Recommendations

“…These include: (i) seeking a licensed therapeutic alternative, (ii) importing products authorised in other countries (which can be costly, time-consuming, and often subject to strict regulations), (iii) compounding medicines within the pharmacy (i.e. preparing an unlicensed medicine to meet specific patient needs) or (iv) manipulating licensed dosage forms [5][6][7].…”

“…Examples of medicine manipulation include dividing/crushing a tablet, opening a capsule and emptying its contents, making serial dilutions, mixing syrup into a crushed tablet to prepare an extemporaneous preparation, and mixing a medicine with food or drinks (vehicles) to aid administration. Several risks have been associated with drug manipulation practices, including inconsistent results in terms of dose accuracy and possible effects on drug stability, solubility and bioavailability [7,[9][10][11]. Ultimately, these practices may lead to subtherapeutic or even toxic drug levels and/or increase the risk of side effects, which raises safety concerns [1,7,12,13].…”

“…Several risks have been associated with drug manipulation practices, including inconsistent results in terms of dose accuracy and possible effects on drug stability, solubility and bioavailability [7,[9][10][11]. Ultimately, these practices may lead to subtherapeutic or even toxic drug levels and/or increase the risk of side effects, which raises safety concerns [1,7,12,13]. Therefore, there is a need to evaluate the impact of drug manipulation practices and standardise recommendations and administration procedures to reduce the risks associated with medicine manipulation.…”

“…Clear instructions on the optional use of vehicles to facilitate medicine administration should be included in the labelling, summary of product characteristics (SmPC) and patient information leaflet (PIL) of the commercial formulation [5,15]. However, many factors such as seasonal, regional and climate conditions as well as age-related characteristics, disease state and indication will influence vehicle composition or preference, respectively [7]. For example, diet preferences will change depending on the age group (e.g.…”

“…It should be noted though that information regarding formulation co-administration with food and drinks is not included in the pilot monographs available [17,19]. In practice, recent studies have shown that medicine coadministration with vehicles is often performed without following recommended procedures [7]. Parents, carers and healthcare professionals often choose or let the child choose the food or drink used for medicine co-administration, without following the recommendations stated on the PIL or SmPC of the medicine [7,13,14].…”