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Author: Admin | 2025-04-28
(Nahata, 1999). Hence, pediatric drug formulations have attracted considerable attention from private and government institutes. Excipients are the inactive ingredients in drug formulations and should be safe for human use. However, some additives that are safe in adults might not be suitable for pediatrics, especially in infants and newborns babes owing to their physiological features and age-related maturation of tissue functions (Nunn, 2003). Further, as child friendly formulations are inadequate, incompliance to the prescribed regimen of medication is noted in children, resulting in the lack of therapeutic effect (Standing et al., 2005). This is especially critical in the case of cancer or infectious diseases in the pediatric population. Hence, to date, parents and nurses continue to use extemporaneous compounding to help children take the current adult formulations.In 1997, the FDA implemented pediatric regulations and legislation in the US. Furthermore, draft guidance on pediatric clinical studies have been published by the American Academy of Pediatrics and FDA (Food and Drug Administration, 1998) (Shaddy and Denne, 2010). In addition, the World Health Organization (WHO) published a position report for desired pediatric dosage forms and integrated it in a Model Essential Medicines List for Children (World Health Organization, 2010). This report stated a policy on oral pharmaceuticals suitable to children, especially in the developing countries, and specified the need for solid oral dosage forms for easy transport in pediatrics, since they do not require refrigeration, are easy to reconstitute with tap water, and can be given at the right dose, such as orally disintegrating dosage forms, multi-particulate formulations in the form of powders/sprinkles, mini-tablets, and chewable tablets. However, formulations for pediatrics are not commercially available in the developing world owing to the difficulties in the development and storage of such formulations (Sosnik et al., 2012). Although most pediatric formulations of BCS classes 1 and 3 drugs are in the liquid form, many drugs, including those for chemotherapy or HIV, belong to BCS classes II and IV, which are poorly soluble in water and bitter in taste, and thus pose challenges in oral drug development (Milne and Davis, 2014).Drug solubility and taste can be altered by chemically modifying, masking by encapsulation, or adding sweeteners to the drugs. Drug absorption is affected by the choice of polymers or excipients. In addition to taste masking, polymeric encapsulation can improve the drug solubility and stability and allow controlled drug release and absorption (Weuts et al., 2011). These
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