Table 6 Target Product Profile for paediatric praziquantel formulations
Description | Praziquantel paediatric formulations using: (i) the racemic mixture of praziquantel (ii) only L-praziquantel |
|---|---|
Indication | Treatment of schistosomiasis (Schistosoma mansoni and S. haematobium) |
Target population | Children (3–6 months to 6 years) with proven schistosomiasis infection able to take oral medication and not receiving co-medication for other diseases |
Dosage and administration | Orally disintegrating tablet (taste masked) administered orally (as intact tablet or dissolved in water) as a single-dose treatment (in mg/kg of body weight) |
Stability in WHO zone IVb climatic conditions (hot, humid climate, 30 °C/75% RH) | Minimum case scenario: stable for 18–24 months Base case scenario: Stable for 24–36 months High case scenario: Stable for > 36 months |
Packaging | Primary packaging: HDPE bottles with or without desiccant (low bulk, weight and volume packaging material) if feasible. Package sizes that Allow optimal use under public health programme conditions Approximately 50–100 units per bottle |
Key statement | The new formulation will be suitable for paediatric use in Sub-Saharan Africa, Brazil and other endemic countries. It will be appropriate for use in both case management administration and community directed mass treatment (i.e. large-scale preventive chemotherapy). This will require further post-regulatory approval field studies to assess effectiveness |