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Wish list for design of Paediatric formulations Young Children • Syrups reserve for < Wish list for design of Paediatric formulations Young Children • Syrups reserve for < 10 -15 kg – No need refrigeration – Stability data for longstorage times, at high temps and high humidity – Small volumes – Package storage info for 28 -35 days – According to: • 2 -3 kg bands in younger children (can be 5 kg in older kids) – Provide dose administrator with packaging: • ? Re-usable syringe • ? Use bottle-tops; ? Teaspoons – less exact – Taste dependent on culture, but aim to cover bad tastes – If possible not glass bottles!! – If possible think of alternatives to syrups • sachets; granulates; dispersable tablets

Wish list for Paediatric formulations Older Children • Solid formulations >10 -15 kg – Wish list for Paediatric formulations Older Children • Solid formulations >10 -15 kg – Crushable tablets may be cheapest; • granulates; dispersable tablets might be better – Same issues storage, packaging 28 -35 days; 5 kg bands; taste; – Use of smaller adult tablets for single drugs, and scored tablets

Single Drug priorities • Scaling down dose of and scoring adult tablets: – Only Single Drug priorities • Scaling down dose of and scoring adult tablets: – Only need chemistry (but may need expensive stability data) if you have comparable PK data across ages; probably don’t need bio-equivalence data for regulatory: • 3 TC; ZDV; D 4 T; ABC; NVP; EFV • Already have for NFV tablets • Ask companies to re-look at formulations used during the development process • New scaled down tablets of drugs not yet available for children: – TDF lower dose tablets e. g. re-use 75 mg tablet and/or score tablets

FDCs - Principles • If need different ratios of drugs compared to adult FDC, FDCs - Principles • If need different ratios of drugs compared to adult FDC, will need separate bio-equivalence studies to be done: – In healthy adults (generally not in children) – Cross-over studies with standard single drugs – (for FDA, need to be US approved single drugs) • Some drugs cannot be put together clinically or chemically? : – ZDV/3 TC/TDF – always need ZDV bid and TDF od – Tablets or Powders – PIs hard to combine with anything except themselves !! (Soft gels/liquids hard to combine with other drugs) • Packaging needs attention • Stability and dissolution data will be needed

Pre – FDCs Co-packaging of single drugs • Attention to packaging – must be Pre – FDCs Co-packaging of single drugs • Attention to packaging – must be OK for all the drugs – or else need to go back and do 12 month stability studies • Possibilities egs: – ZDV, 3 TC, EFV – dd. I, 3 TC, EFV

2 -drugs FDC priorities • Those already available for adults and PK data available 2 -drugs FDC priorities • Those already available for adults and PK data available for children: – d 4 T/3 TC – ZDC/3 TC – 3 TC/ABC • Full data not yet available for children: – FTC/TDF (nb these are within the same companies)

3 -drugs FDC priorities • Immediate: Those already available for adults: – d 4 3 -drugs FDC priorities • Immediate: Those already available for adults: – d 4 T/3 TC/NVP – ZDC/3 TC/NVP – ZDV/3 TC/ABC • FTC/TNF/EFV (planned for adults; plan for children at the same time) (nb ? IPR as across 2 companies)

Learn from other areas – Anti-TB and Antimalarial drugs • Do paediatric PK studies Learn from other areas – Anti-TB and Antimalarial drugs • Do paediatric PK studies using adult formulations (registered) where there are no PK in children: – Show that there is a need for scored and smaller tablets – Then use private-public partnership to develop paediatric formulation (granulates for FDCs for malaria) – Need to advocate for PK paediatric studies in the field on the target population!

Recommendations and Ways Forward I • Advocacy (press releases, statements, etc) about need for Recommendations and Ways Forward I • Advocacy (press releases, statements, etc) about need for treatment and paediatric formulations for children (WHO, UNICEF, MSF, other stakeholders) • WHO convenes a meeting to bring national and other relevant regulators (wide representation from relevant areas) together to agree minimum drug product specific criteria acceptable for paediatric single drugs and FDCs

Recommendations and Ways Forward II • Expression of interest from organisations who will buy Recommendations and Ways Forward II • Expression of interest from organisations who will buy drugs (UNICEF, Global Fund, PEPFAR, Clinton, Gates) (Need estimates of numbers) – Advocacy for alternative systems for drug development eg PPPs (models are MMV; GATB; FIND; GAVI; DNDI) – who? ? ? GATES ? UNICEF; Rockefeller; TDR) – Further engage Pharmaceutical companies • WHO 3 X 5 estimates of numbers of children needing and will be on treatment over specific time-frames

Recommendations and Ways Forward III • Make EOI for paediatric formulations a priority HIV/AIDS Recommendations and Ways Forward III • Make EOI for paediatric formulations a priority HIV/AIDS department at WHO (3 x 5) • Capacity development for companies to fulfil dossiers for pre-qualification (WHO EDM) • Strengthen National Regulatory authorities to enable fast-tracking through pre-qualificiation (EDM) • Based on drug priorities, approach and start dialogue with relevant companies (everyone, WHO 3 X 5)