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

Abstract

Medicine 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.

Assessing the Appropriateness of Formulations on the WHO Model List of Essential Medicines for Children: Development of a Paediatric Quality Target Product Profile Tool

“…Although global paediatric regulations define the paediatric population as being aged from birth to less than 16 or 18 years [ 30 ], the EMLc is intended for use in children up to the age of 12 years; therefore, the tool was designed to focus on this age group. Regulatory agency guidelines on paediatric pharmaceutical development have provided recommendations regarding the need for dose flexibility, patient acceptability, and excipient safety, as well the requirement to consider method of medicine administration and the use of appropriate measuring devices [ 18 ] and these aspects have been extensively discussed in the literature [ 1 , 5 , 19 , 21 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 ]. It is of key importance that paediatric patients can easily be administered the required dose and hence a formulation should allow the required flexibility of dosing according to age, body weight, or surface area, as appropriate.…”

BCS-based biowaivers: Extension to paediatrics

“…For amoxicillin testing, capsules were put in sinkers 12 (Quality Lab Accessories LCC, USA). Sample collection took place at 5,10,15,20,30,45,60,75,90 and 120 min. 2 mL samples were withdrawn (with volume replacement) using a 2 mL glass syringe (Fortuna Optima ® fitted with a stainless tubing) through a cannula (Quality Lab Accessories LCC, USA).…”

Evaluating the Taste Masking Ability of Two Novel Dispersible Tablet Platforms Containing Zinc Sulfate and Paracetamol Reconstituted in a Breast Milk Substitute

“…As a natural product, it might also have less of a safety concern. The use of milk or infant formula in the formulation, or administration, of medicines is established in the literature [19][20][21][22]. However, there are limited studies, to date, on the use of milk to improve palatability.…”