Accordingly, the submission of a paediatric investigation plan (PIP) is now required for any new product development.
The development of an age-appropriate medicinal product and the compiling of a PIP require expertise and experience in areas such as:
- adequate dosage forms
- suitability of excipients
- taste-masking techniques
The NextPharma development team has the expertise and capability to be a trusted partner and to support customers' paediatric product development strategies through a systematic and focused approach. NextPharma provides pharmaceutical product development expertise from Phase I clinical trials with scale-up capability through to commercial scale production, in line with FDA standards and EU regulations.
NextPharma's experts will assist you in developing any paediatric medicinal product, taking account of relevant factors to design the most appropriate formulation for the targeted age group.
NextPharma is proud of its expertise in developing dosage forms suitable for the paediatric population, such as granules, pellets, mini-tablets and liquids. The use of age-appropriate excipients is one key element of these formulation developments. This expertise is complemented by know-how in providing different taste-masking techniques and improved palatability dosage for which are assessed by using an electronic tongue system as an analytical in vitro tool.