Only one-fifth of the 13,000 or so prescription medications sold in the United States are formulated for use in infants and children.

"Increasing numbers of drugs prescribed to children are sold only in adult-sized doses," said Milap Nahata, the chair of pharmacy practice and administration at Ohio State University. "That makes it extremely difficult for pharmacists and doctors to formulate the relatively minute amounts of medicine a pediatric patient needs.

"It's not that adult-sized medications can't be used to treat a child; it's that pharmaceutical companies typically concentrate on the adult market when making a new drug," Nahata added. He is co-author of Pediatric Drug Formulations, a manual that describes how to make infant- and child-suitable formulations of prescription-only drugs.

"The manual is a reference for healthcare providers charged with formulating doses that a small child's body can handle," Nahata said.

The latest edition, published this spring, includes 280 formulations for drugs that are commonly used to treat children, but aren't manufactured in child-friendly doses. Most prescription medications are created for people 12 and older, said Nahata.

But there is an ever-increasing need for information on how to formulate such drugs for babies and small children. Children -- especially those 7 and younger -- often have a hard time swallowing tablets or capsules and need doses tailored to their body weight. Also, intravenous medications are typically in too high a concentration for a child's body.

"Intravenous drugs represent a serious problem," Nahata said. "A small error in measuring a child-size dose could potentially be toxic."

Nahata and his co-authors Vinita Pai and Thomas Hipple, both with Ohio State, chose which drugs to include in the new edition based on their experience working with children. The number of drugs addressed has nearly increased five-fold from what was in the original manual, which included formulations for 60 medications.

"New drugs are coming out all the time," said Pai, a clinical assistant professor of pharmacy at the university. "For example, a handful of anti-seizure drugs came to market in the last decade, but they were in tablet or capsule form. If a young child needed the drug, we had to figure out how to create it in liquid form."

"We are also seeing more children with hypertension," said Nahata. "About 1 percent of children in the United States have hypertension. All of a sudden, we needed to come up with suitable liquid formulations for those kinds of drugs, too."

These formulations are new additions to the manual.

"It doesn't matter if a drug is prescribed to children daily, or that only one child in a thousand needs it," Nahata said about the medications in the current manual. "Either way, we still need to make available a suitable formulation of a drug."

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CITATIONS

Book: Pediatric Drug Formulations