Concerns in Formulations for Pediatrics

If a drug is to be given by injection, i.m. or i.v., this may require only volume variations. But most drugs developed for adults are given by the oral route, as tablets, capsules or caplets. The adult formulation is usually determined by marketing considerations. Invariably, for children, especially under age 7 years, liquid or syrup must be formulated. Most drugs taste bitter or unpleasant (which is why most tablets are sugar-coated). Sometimes, it may be impossible to completely mask the taste. A commitment to a pediatric formulation requires a whole gamut of testing and the development of specific product specifications. If the liquid formulation changes the bioavailability (faster or slower absorption), then further efficacy and safety studies may be required. A further concern is that liquid formulations often have a shorter shelf life than tablets. Finally, stability characteristics or other factors may make it impossible to make a liquid or syrup or glycolated elixir, sprinkle beads or powder sachets, and split or crushed tablets may be a last resort. In the later two cases, an even distribution of active compound and other inactive excipients must be demonstrated. In addition, a lack of effect an bioavailability must be proved if such advice is to appear in the dosing instructions.

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