Roy Turner

Playing hide and seek with poorly tasting paediatric medicines: Do not forget the excipients☆

The development of paediatric medicines can be challenging since this is a diverse patient population with specific needs. For example, the toxicity of excipients may differ in children compared to adults and children have different taste preferences. Acceptable palatability of oral paediatric medicinal products is of great importance to facilitate patient adherence. This has been recognised by regulatory authorities and so is becoming a key aspect of paediatric pharmaceutical development studies. Many active pharmaceutical ingredients (APIs) have aversive taste characteristics and so it is necessary to utilise taste masking techniques to improve the palatability of paediatric oral formulations. The aim of this review is to provide an overview of different approaches to taste masking APIs in paediatric oral dosage forms, with a focus on the tolerability of excipients used. In addition, where possible, the provision of examples of some marketed products is made.

European Paediatric Formulation Initiative (EuPFI)-Formulating Ideas for Better Medicines for Children.

The European Paediatric Formulation Initiative (EuPFI), founded in 2007, aims to promote and facilitate the preparation of better and safe medicines for children through linking research and information dissemination. It brings together the capabilities of the industry, academics, hospitals, and regulators within a common platform in order to scope the solid understanding of the major issues, which will underpin the progress towards the future of paediatric medicines we want.The EuPFI was formed in parallel to the adoption of regulations within the EU and USA and has served as a community that drives research and dissemination through publications and the organisation of annual conferences. The membership and reach of this group have grown since its inception in 2007 and continue to develop and evolve to meet the continuing needs and ambitions of research into and development of age appropriate medicines. Five diverse workstreams (age-appropriate medicines, Biopharmaceutics, Administration Devices, Excipients and Taste Assessment & Taste Masking (TATM)) direct specific workpackages on behalf of the EuPFI. Furthermore, EuPFI interacts with multiple diverse professional groups across the globe to ensure efficient working in the area of paediatric medicines. Strong commitment and active involvement of all EuPFI stakeholders have proved to be vital to effectively address knowledge gaps related to paediatric medicines, discuss potential areas for further research and identify issues that need more attention and analysis in the future.

Towards the development of a paediatric biopharmaceutics classification system: Results of a survey of experts.

The aim of this research survey was to understand current global thinking around the need for and development of a paediatric biopharmaceutics classification system (pBCS) to be used for the development of paediatric medicines and regulatory purposes (e.g. Biowaivers). A literature review highlighted the paucity of data in this area and therefore a survey was developed to better understand this topic to identify areas of common thinking and highlight future research needs. Global experts in paediatric biopharmaceutics were identified from existing networks and public forums. An online survey was developed and circulated broadly to maximise participation. Sixty individuals (including academics, health care professionals, pharmaceutical industry scientists and regulators) completed the survey, bringing together their views on the need for a pBCS. The results highlighted that the area of greatest concern was the definition of BCS II and IV drugs within this population and additional research is required to generate evidence to underpin this issue. In questions relating to permeability and dissolution consensus was generally reached within the expert population suggesting that little additional research is required to define suitable criteria. More than 90% of those experts who participated agreed that a pBCS would be useful for paediatric populations with a greater need identified for the younger populations (newborn and infants compared to adolescents). The results presented will facilitate further discussion and research into the evidence to underpin a relevant pBCS. These results highlight the need for additional evidence and guidance in this area.

Impact of sodium lauryl sulfate in oral liquids on e-tongue measurements

During development of oral liquid medicines taste assessment is often required to evaluate taste and taste masking. Electronic tongue analysis can provide taste assessment of medicinal products but should only be conducted with medicines that interact with the instrument without damaging the sensor membranes or interfering with their electrical output so that robust data is generated. To explore the impact of a substance deemed unsuitable for electronic tongue analysis the influence of the anionic surfactant sodium lauryl sulfate (SLS), on the performance of the electronic tongue was conducted using electronic tongues equipped with self-developed PVC based sensors. The results showed a significant impact of SLS on all applied sensor types and an alteration of the sensors sensitivity. Nevertheless, concentration dependent sensor responses could still be obtained and the sensor performance was not impacted negatively. Assessment of unsuitable substances should therefore be evaluated prior to performing electronic tongue analysis so that their impact is understood fully.

Data for a pre-performance test of self-developed electronic tongue sensors.

This article presents data, which can be applied for a pre-performance test of self-developed electronic tongue sensors. Contained data is related to the research article “Impact of Sodium Lauryl Sulfate in oral liquids on E-Tongue Measurements” (http://dx.doi.org/10.1016/j.ijpharm.2016.10.045; (L.I. Immohr, R. Turner, M. Pein-Hackelbusch, 2016) [1]). Sensor responses were obtained from 10 subsequent measurements and four different concentrations of quinine hydrochloride by electronic tongue (TS-5000Z, Insent Inc., Atsugi-Shi, Japan) measurements. Based on the data for the pre-performance testing, which were calculated based on the fluctuation range of the sensor responses around the median, stability criteria and required preconditions cycles were defined.