A pediatric population is a diverse group comprising of different subgroups. The use of unlicensed and off-label medicines for treating children is widespread due to the non-availability of suitable dosage forms for this age group. Although physiological differences related to the diverse age group remains an important consideration, various other challenges like insufficient background information on drug molecule, excipient safety, taste masking issues, technology requirements, low profitability, limitations in conduct of clinical trials and lack of regulatory clarity are also important factors affecting pediatric dosage forms development adversely. These factors are discussed in this review. Liquids are the most preferred dosage forms for children, especially of lower age. However, in the absence of suitable or labelled dosage forms, physicians and caretakers are left with no choice but to use off-label, specials or extemporaneously prepared formulations. All such non-standard formulations are devoid of relevant scientific data and hence pose a high risk to pediatric patients. The situation is even more serious with developing countries where health care guidelines and controls for pediatric patients scarcely exist. Though in recent past safe, effective and labelled dosage forms are increasingly becoming available, pediatric development still struggles to find the place in the mainstream pharmaceutical development programs.
Key words: Pediatric population; pediatric formulations; excipients for pediatric formulations; taste masking; pediatric drug delivery
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