Drug formulations pediatric studies

For drugs that are new molecular entities (NMEs), a determination should be made by the sponsor of the potential usefulness of the new drug in a pediatric population. If it is likely to generate over 100 000 prescriptions per year, this would indicate the need to develop a pediatric formulation and suitable pediatric studies. If it is likely to generate less than 50 000 prescriptions per year, the sponsor may be granted a waiver by the FDA for pediatric data, and a disclaimer statement allowed. Either way, in a children s disease, if less than 200 000 patients per year may benefit, then orphan-drug status with 7 per year exclusivity may be applicable. This would then apply only to that pediatric indication. 

Recent studies evaluated Sesamum indicum L., sesame (Pedaliaceae) gum for its useful properties in the drug industry as a binder/hydrophilic polymer in the formulation of sustained release paracetamol granules and tablets, compared with standard binders Arabic gum, gelatin, and sodium carboxymethylcellulose [277] for the intestinal delivery of antifilarial drug diethylcarbamazine tablets [278] as an accessible, cost-effective and eco-friendly suspending agent in a pediatric pharmaceutical suspensions, compared with Arabic gum and tragacanth [279]. 

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