European Paediatric Formulation Initiative

The intrinsic properties of the active substance are difficult to change, but the pharmacist can choose the right excipients and preparation techniques to overcome or decrease the impact of limitations. Although excipients should be pharmacologically inactive, they may cause adverse effects. The European Paediatric Formulation Initiative (EuPFI) project is considering the suitability of excipients for paediatric formulations. The results have been published in the STEP database [13]. For example many colouring agents have been associated with hypersensitivity and other adverse reactions. 

Sam T, Ernest TB, Walsh J, Williams JL (2012) On behalf of the European paediatric formulation initiative (EuPFI). A benefit/risk approach towards selecting appropriate pharmaceutical dosage forms - an application for paediatric dosage form selection. Int J Pharm 435 115-123... 

STEP Database. European paediatric formulation initiative, http // pharmacyapp-a.ucl.ac.uk 8080/eupfi. Accessed 13 Apr 2015... 

As mentioned in Table 5.18, some of the excipients are not suitable for children. The information available on the acceptability of excipients for paediatric age groups is sparse and distributed over various sources. Hence, European (Eu) and United States (US) Paediatric Formulation Initiatives (PFls) are collaboratively creating a database Safety and Toxicity of Excipients for Paediatrics (STEP). This STEP database provides specific safety and toxicity data on target age groups, route of administration, treatment duration, concentration, maximum daily excipient intake and exposure extracted from selected information sources. The data in the STEP database would be derived firom publicly and commercially available information sources together with any information shared by the industry. It will be accessible freely online thereby facilitating paediatric formulation development. 

The European - United States Paediatric Formulation Initiative (Eu-US PEI) has established that there is a pressing need for a single authoritative comprehensive database of adverse effects of excipients for paediatrics. Safety and Toxicity of Excipients for Paediatrics (STEP) Database holds all the animal toxicity and human health data, regulatory information and toxicological reviews of excipients. STEP acts as repository for all the scientific communities to share the data for better understanding and paediatric medicines development (European Paediatric Eormu-lation Initiative. STEP Database. See [3]). 

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See also in sourсe #XX -- [ , ]

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