Paediatric Medicines: Formulation Considerations

Abstract

The use of unlicensed and off-label medicines in children is widespread and has raised an increasing concern over the last years. The majority of medicines taken by children are extemporaneously compounded by pharmacist, and there is a lack of information regarding bioavailability, suitability and stability. These formulations must be prepared from pure active substance and not from commercially available dosage forms. The development of paediatric formulations, particularly those suitable for very young children, can be a challenge to pharmacists. There is limited knowledge available about the acceptability of different dosage forms, administration volume, dosage form size, taste, safety of formulation excipients regarding to age and development status. The selection of formulation and route of administration depends on the disease being treated and the clinical condition. European Guidelines and refl ection papers recommend that pharmaceutical development should consider some parameters like capability, acute or long-term illness, caregiver convenience, disability, culture differences and formulations more attractive to children must be explored.

Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review

“…Extemporaneous preparations are not required to meet certain standards from the regulator [ 92 ]. The main purpose of regulation is to ensure the efficacy and safety of drug use [ 3 ].…”

“…Compounding is an important activity of pharmacists that aims to provide dosage forms or certain doses of unavailable medicine among licensed drugs [ 2 ]. Extemporaneous preparations remain widely used, especially for pediatric patients [ 3 , 4 ], patients with rare diseases [ 5 , 6 ], patients who require special dosage forms [ 7 ] or certain doses/strengths, and dermatological patients [ 8 , 9 ]. Compounding is performed by various pharmaceutical services, including in pharmacies, hospitals, and health centers [ 3 , 10 ].…”

Extemporaneous Compounding: Prevalence, Risks and Quality Assurance

“…A significant number of pharmacies provide compounding services but the prevalence of extemporaneous dispensing is generally low, estimated to be less than 5% of health products (Wiedyaningsih et al, 2017). Generally, prevalence is higher for dermatological and pediatric products due to unavailability of commercial preparations that are tailored towards a specific patient condition (Moulis et al, 2018;Fátima, 2017;Pappas et al, 2002). A comprehensive literature searches for the period (1996)(1997)(1998)(1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015) revealed that the occurrence of extemporaneously compounded products in most pharmacies in United Kingdom, New Zealand, Belgium, France, Australia and the Netherlands to be less than 5% (Kristina et al, 2017).…”