The Need for Extemporaneously Compounded
Medications for Pediatric Patients

It has been estimated that over 80% of drugs approved by the FDA are not labeled for pediatric populations. For example, in 1997, only 5 of the 80 drugs most commonly used in newborn infants were labeled for neonatal use. Therefore, these drugs are usually not available in suitable pediatric dosage forms (i.e, liquid, chewable, or transdermal). The small pediatric market may be the leading reason for the lack of investment in drug development for this population by the pharmaceutical industry.

Pediatricians and other specialists are dedicated to addressing the unique needs of their young patients, and compounding pharmacists possess the creativity to meet their needs. Preparation of customized medications for pediatric patients is much more than dilution of more concentrated dosages. Consideration must be given to:

•  appropriate vehicle/base
•  physical or chemical properties of active ingredients
•  use of preservatives that are safe in children
•  taste
•  odor
•  viscosity
•  color
•  uniformity
•  smoothness/grittiness
•  stability

An ideal oral drug for children should be effective, well tolerated, and have good palatability, i.e. acceptable taste, after-taste, and smell. A palatable formulation is more likely to improve compliance and minimize spillage or waste during administration of doses.

Medications are often complex mixtures containing many other components besides the active ingredient. Liquid formulations must often be prepared at the time of dispensing by the pharmacist, using appropriate excipients (inactive ingredients) which consist of bulk materials, flavorings, sweeteners, and coloring agents. Unlike the active ingredients, excipients are not well regulated in most countries. Although most are well tolerated, a variety of excipients cause adverse side effects and idiosyncratic reactions. Proper selection and use of these substances is critical, especially in liquid and chewable preparations that are mostly consumed by infants and children.

NIH News Alert  Nov.25, 1997
Secundum Artem 8(3)
Paediatr Drugs. 2002;4(6):371-9

We can compound the needed medication in the most appropriate dosage form, and eliminate problem causing excipients such as lactose, dyes, sugar, alcohol, and preservatives.

Copyright 2004, Storey Marketing - Monthly Website Updates. Reproduction prohibited. Subscription available through Storey Marketing (814-337-3441). Questions regarding this article should be directed to the compounding professionals at Thrifty Health and Compounding Pharmacy.