Pharmaceutical excipients and pediatric formulations
Pharmaceutical excipients used in pediatric formulations have received significant attention from regulatory agencies worldwide due to the safety concerns. Many excipients have been implicated in interfering with the growth and development process of pediatric population. Excipients require thorough short-term and long-term safety evaluation in pediatric population prior to their incorporation in pediatric formulations. This mini-review will discuss the safety impact of the excipients with reference to the chemical structure, chemical reactivity, and doses used, to the toxicity observed in pediatric population. In addition, the review will highlight the excipients that can be substituted for in pediatric formulations to ensure safety and efficacy of such products.
Dosage formulations developed specifically for pediatric population have been few and far between due to the fact that children require fewer medications to treat their ailments unlike adults. Hence, the impetus to develop dosage forms for pediatric population has been slow. Almost all therapeutic agents administered to pediatric population are adult dosage forms that lack any labelling information for dosing in pediatric population, suffer from patient compliance, are administered at doses not appropriate for pediatric population and contain many formulation excipients have been shown to produce toxicity in pediatric population (1). Some of the most common toxicities encountered with excipients in pediatric population include bronchospasms due to the presence of benzalkonium chloride in antihistaminic drugs, headaches and seizures as a result of aspartame which is used as a sweetener, and the use of benzyl alcohol which caused toxicity in neonates, and hyperosmolality and lactic acidosis due to propylene glycol (2, 3). It is only recently that drugs marketed in the US are being clinically evaluated in pediatric pop ...