Safe, swallowable and palatable paediatric mini-tablet formulations for a WHO model list of essential medicines for children compound – A promising starting point for future PUMA applications

More than 10 years after the Paediatric Regulation came into place there is still a strong need for pure paediatric medicines for off-patent drug substances. Numerous compounds for which a paediatric formulation does not exist can be found on the WHO Model List of Essential Medicines for Children and in the EMA Inventory of the Needs for Paediatric Medicines. Many of these compounds are off patent, which offers the opportunity for obtaining marketing authorisations for paediatric use.

The present study focused on the development of paediatric immediate-release mini-tablet formulations for furosemide. Essential formulation criteria included the use of excipients that are regarded as safe for children, the ease of manufacturing, a high dose flexibility, fast disintegration, a robust drug release and a good acceptability.

Only excipients regarded as safe for use in children were used in formulation screening. Compressibility, tablet hardness, disintegration and palatability were the main screening parameters. Formulations with a hardness of  > 20 N, a disintegration time < 3 min (fast disintegration) and a good palatability were selected for mini-tablet production. Based on this pre-assessment two mini-tablet formulations with a furosemide drug load of 2.5 mg were developed. Both were easy to manufacture, have an appropriate hardness, a short disintegration time and met pharmacopoeial requirements with regard to content uniformity and physical testing. Biorelevant in vitro dissolution experiments mimicking different modes (with water or dosing vehicles) of administering age-appropriate furosemide doses to children of different age groups indicated a fast and robust drug release. Overall, the novel mini-tablet formulations present with an increased dose flexibility, excipient safety, swallowability and palatability and are thus a promising starting point for the development of solid oral dosage forms for drugs with paediatric therapeutic needs. More on Safe, swallowable and palatable paediatric mini-tablet formulations.

Are you interested in pediatric formulations? Join the 12ht EUPFi Conference September 9-10, 2020 – virtual

Programme

Scientific Programme
The meeting will include two keynote speakers, focus session one each workstream and 2 soap box session.  e-Posters will be available for stimulating discussion during the live sessions and chatrooms throughout the meeting. View the meeting programme as a pdf file

Poster and oral presentations will be available on-demand in the virtual session room and poster hall. Participants can engage in discussions with presenters via text chats. You can search the presentations in these spaces using the search function within the platform.  Further, live Q&A discussions will also be held after every talk. Be sure to review the live session discussion schedule to ensure that you viewed all presentations in related session ahead of the discussion to fully engage. To get the most out of these session discussions, it is highly recommended to arrive prepared and to watch the talks and posters of that session before you enter the session discussion. Detailed technical questions can best be  addressed in the chat boxes of the individual talks and posters. The live sessions will be recorded and will be made available for viewing on demand.

Note: We are using Zoom for live sessions through our meeting platform provider’s viewer. All presentations can be viewed without Zoom.

Networking
Don’t miss regular visits to the Networking Lounge to engage with others in topical chat rooms. If you are looking for someone specific, go to the delegates area and search based on their profile (name, affiliation, country or scientific area of interest). Every day, the conference will open its doors for one hour to mingle with others. Opening is at 13:00 CET on wednesday, 9th Sept.

Note: Attendees can have multiple chat boxes open at the same time (e.g., associated with topical chatrooms and presentations.

Exhibits
During the conference, you are encouraged to visit the exhibitor booths and see all they have to offer.

EuPFI Young Scientist Award and Poster Presentation Award
Each year at the annual meeting, students and young scientists compete for the EuPFI young scientist and Poster Presentation awards. For more information and to participate.

After the Meeting

All delegates will receive an electronic certificate of attendance after the meeting.  We always appreciate the feedback, and delegates will receive a survey shortly after the meeting.

We look forward to seeing you online very soon!!