CommentaryChallenges of developing palatable oral paediatric formulations
Introduction
The development of paediatric medicines can be very challenging. This was recognised by the European Paediatric Formulation Initiative (EuPFI), a group consisting of paediatric formulation experts predominantly from industry, as well as academia and clinical pharmacy. EuPFI was founded in 2007 with the aim of raising awareness of paediatric formulation issues. The current focus areas of the group include excipients, taste assessment, delivery devices for the administration of medicines, and extemporaneous preparations. This commentary, paper written in response to the recent editorial (Florence, 2008) entitled ‘Neglected diseases, neglected technologies, neglected patients?’ highlights, on behalf of this group, some of the challenges related to masking the taste of poorly palatable drugs that are encountered on a regular basis during development of oral paediatric medicines.
The development chart (Fig. 1) illustrates the differences between the drug development processes for adults and children. Since the new Paediatric Regulation came into force in the European Union in January 2007 (EMEA, 2006), a Paediatric Investigation Plan (PIP) outlining the paediatric drug product strategy needs to be agreed with the EMEA's Paediatric Committee at an early stage of development (no later than completion of the relevant human pharmacokinetic studies in adults). At this early development stage, only very limited data are likely to be available to guide paediatric formulation development. Taste data would not usually be available at time of writing the PIP, and final paediatric dose(s) may not be defined until later in the development programme. Therefore any information about paediatric dosage form(s) of choice, whose selection will be influenced by taste masking potential and palatability, is likely to be limited in the PIP.
Section snippets
Discussion of challenges of developing palatable formulations
Palatability of paediatric oral medications is crucial for adherence to therapeutic regimens (Matsui, 2007). However, development of a palatable formulation can be associated with significant challenges that are discussed in the following paragraphs.
Conclusion
Palatability of paediatric oral medications is one of the most crucial factors influencing adherence to therapeutic regimens and therapeutic outcomes. Following implementation of the new European Paediatric Regulation, there is a real incentive for palatability research to be progressed. Indeed the PIP guidelines list taste masking and palatability as proposed studies of particular relevance to the development of paediatric products (EMEA, 2007).
Development of palatable paediatric formulations
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