Table 1 Target Product Profile for pediatric praziquantel
Description | Praziquantel pediatrica |
|---|---|
Indication | Treatment of schistosomiasis (Schistosoma mansoni and. 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). |
Target efficacy | Minimum case scenario: Cure rate in phase III trial is between 60-75% Base case scenario: Cure rate in phase III trial is 75% High case scenario: Cure rate in phase III trial is above 75% |
Target safety | A safety and tolerability profile equal or better than that of current praziquantel tablets. |
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 program conditions. Approx. 50–100 units per bottle |
Key statement | The new formulation will be suitable for pediatric 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. |