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Project Portfolio Benznidazole Paedriatric dosage form
Project Portfolio Benznidazole Paedriatric dosage form
Paediatric dosage form of Benznidazole (Chagas)
• Target disease: Chagas • Major Partners: Laboratório Farmacêutico do Estado de Pernambuco (LAFEPE), Brazil; Hospital de Niños Ricardo Gutierrez, Argentina; Instituto Nacional de Parasitología, Dr M Fatala Chabén, Argentina; Hospital de Niños de Jujuy, Argentina; Ministério de Salud, Província de Jujuy, Argentina; Hospital Público Materno Infantil – Salta, Argentina; Centro de Chagas y Patologia Regional, Argentina; CONICET/INGEBI, Argentina; Centro Nacional de Diagnóstico e Investigación de Endemo-epidemias (CeNDIE), Ministry of Health, Argentina; University of Liverpool, UK; NUDFAC, Brazil; CRO - LAT Research, Argentina • Management: Head of Chagas Clinical Programme, Isabela Ribeiro; Clinical Trial Manager, Jayme Fernandes; Project Coordinator, Bethania Blum • Project start: June 2008 • Funding: Médecins Sans Frontières/Doctors without Borders, International; Spanish Agency for International Development Cooperation (AECID), Spain; Department for International Development (DFID), UK; individual donors. |
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Status: Benznidazole, a nitroimidazole introduced by Roche in 1971, and licensed to the Brazilian LAFEPE, is one of the two products registered for Chagas disease treatment and is included in the WHO Essential Medicines List. It is supplied in 100 mg tablets and administered twice daily for 60 days at a dose of 5 mg/kg bodyweight/day for adults and 5-10 mg/kg bodyweight/day for children. Extemporaneous formulations and fractionation are needed for most children because no paediatric formulation of the drug exists. Fractionation of tablets is far from ideal because of the high risk of delivering improper dosages, thereby raising concerns about efficacy, safety, and decreased stability. In rural areas of Latin America, where Chagas disease is highly endemic, families are at high risk of contracting the disease. Paediatric benznidazole is produced at the pharmaceutical company Lafepe in Recife, Brazil. With the goal of developing an adapted dispersible tablet of benznidazole suitable for very young children, DNDi and LAFEPE signed a development agreement in July 2008. Using
current benznidazole dose recommendations, data from dosing practices
and patient age and weight profiles from reference centres that treat
children with T. cruzi infections as a guide, the team has
determined the most appropriate paediatric tablet formulation, strength,
and associated dosing regimen (12,5 mg tablets). Biobatch production
was carried out in early 2010 and submission for registration is planned
for the first quarter of 2011. A population pharmacokinetics study is
to start in 2011 in Argentina, involving 80 paediatric Chagas disease
patients, to obtain additional information on pharmacokinetics,
treatment safety, and efficacy for this targeted population. Brazil’s National Health Surveillance Agency (ANVISA) granted registration of the new paediatric dosage form of benznidazole in December 2011. Registration of this child-adapted formulation of benznidazole will be published on 12 December 2011. Last update: December 2011 |
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