Target product profiles for paediatric formulations of azithromycin and nitrofurantoin
Bacterial infections are still a main cause of death in children younger than 5 years, yet few age-appropriate antibiotic formulations exist, which limits treatment options and compromises quality of care. In 2023, the World Health Organization (WHO) published its first list of priority paediatric antibiotic formulations to guide research and development for age-appropriate antibiotic formulations. Both azithromycin and nitrofurantoin are on this list. Currently, no dispersible tablets are approved or available for these drugs and existing liquid forms are poorly palatable and/or contain excipients of safety concern. To support the development of age-appropriate formulations for these two antibiotics, we produced target product profiles using WHO's methods. For azithromycin, the optimum age-appropriate formulation and dose is scored 100 mg dispersible tablets or an orodispersible 50 mg multiparticulate formulation, with dispersible 50 mg tablets as the minimum requirement. For nitrofurantoin, the optimum age-appropriate formulation is an orodispersible multiparticulate formulation or scored dispersible tablets, with dispersible tablets as the minimum requirement. Based on the WHO recommended dosage of 4 mg/kg per day for children for nitrofurantoin, the optimum unit dose is 5 mg. If scoring is feasible, a 10 mg unit dose should be developed for dosing flexibility across paediatric age groups. These profiles aim to support regulatory authorities, pharmaceutical developers, health programmes and other stakeholders in advancing safer, effective and child-appropriate antibiotic formulations.
Authors
- Shabina Ariff (ORCID: https://orcid.org/0000-0002-9627-2662)
- Tim Roy Cressey (ORCID: https://orcid.org/0000-0002-8106-0974)
- Yasir Bin Nisar (ORCID: https://orcid.org/0000-0002-9720-5699)
- Shalini Sri Ranganathan (ORCID: https://orcid.org/0000-0003-0184-104X)
- Martina Penazzato (ORCID: https://orcid.org/0000-0001-5485-8692)
- Catherine Tuleu (ORCID: https://orcid.org/0000-0001-8384-357X)
- Narendra Kumar Arora
- Giulia Brigadoi (ORCID: https://orcid.org/0009-0004-0600-7745)
- James Alexander Berkley (ORCID: https://orcid.org/0000-0002-1236-849X)
- Mary Atieno Ojoo
- Emmanuel Roilides (ORCID: https://orcid.org/0000-0002-0202-364X)
- Murni Karim (ORCID: https://orcid.org/0000-0002-6639-6656)
- Devika Dixit (ORCID: https://orcid.org/0000-0002-5520-0363)
- Mike Sharland (ORCID: https://orcid.org/0000-0001-8626-8291)
- Phoebe Williams (ORCID: https://orcid.org/0000-0003-2250-0594)
- Hilda Mujuru (ORCID: https://orcid.org/0000-0003-1615-3856)
- Julia Bielicki (ORCID: https://orcid.org/0000-0002-3902-5489)
- Amanda Gwee (ORCID: https://orcid.org/0000-0003-4016-8986)
- Lisa Frigati (ORCID: https://orcid.org/0000-0002-7071-5533)
- Robinson D. Wammanda
- Victor Musiime
- Adrie Bekker
- Rajiv Kshirsagar
Institutions
- United Nations Children's Fund (US)
- The University of Sydney (AU)
- University of Padua (IT)
- University of Zimbabwe (ZW)
- Muhimbili University of Health and Allied Sciences (TZ)
- St George's, University of London (GB)
- University of Calgary (CA)
- University of Basel (CH)
- Aristotle University of Thessaloniki (GR)
- Stellenbosch University (ZA)
- Aga Khan University Hospital (PK)
- World Health Organization (CH)
- Ahmadu Bello University Teaching Hospital (NG)
- The Childhood Acute Illness and Nutrition Network (KE)
- Murdoch Children's Research Institute (AU)
- INCLEN Trust International (IN)
- Institute of Infection and Immunity (CA)
- University College London (GB)
- Chiang Mai University (TH)
- Makerere University (UG)
- University of Colombo (LK)
Publication Details
- Journal
- Bulletin of the World Health Organization
- Published
- 2025-12-01
- DOI
- https://doi.org/10.2471/blt.25.294422
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 0.00