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Pediatric drug formulations require further development
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There has been recent progress on the development of pediatric drug formulations, but further development of better medicines for children should focus on a certain set of priorities, according to a review in Pediatrics.
It is essential that pediatric drug medicines are formulated to best suit a child’s age, size, physiologic condition and treatment requirements, according to Verica Ivanovska, PharmD, MPH, and colleagues, who penned the review.
Recent progress, including the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, has promoted an increasing amount of clinical trials and innovations in pediatric drug formulations in the United States. Additionally, “Make Medicines Child Size,” a WHO initiative, highlighted the fact that the lack of pediatric medicines most acutely affects children in developing countries.
Much of the recent progress focuses on oral formulations, which enable dose flexibility, easier administration and better acceptance in children. However, there is more work to be done, according to researchers.
“The new pediatric formulations are only a small part of the full therapeutic arsenal needed to serve all pediatric patients,” they said in the review.
Further development of appropriate pediatric formulations should focus on five priorities, including:
- Continuous prioritization process that focuses on unmet public health issues and ensures drug development aligns with the true clinical needs in children;
- Better use of existing data are required to facilitate pediatric drug development;
- Future research on pediatric formulations could potentially benefit from existing or innovative technologies under development in adults;
- Ongoing technologic advances should be accompanied by relevant patient outcome studies and clinical feedback on efficacy, safety, patient acceptability, preferences and adherence regarding new formulations; and
- The financial accessibility of these new pediatric formulations on the market and in daily practice.
“It is essential that there is a committed collaboration between stakeholders that extends across disciplines and geographic regions. Moreover, this collaboration should have the innovative potential to further shape the pediatric drug development agenda and thus to close the adult-child medicine gap,” the researchers concluded.
Disclosure: One of the researchers has financial ties with AstraZeneca, Bristol-Myers Squibb and Pfizer.
Perspective
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Leah Molloy, PharmD
Several obstacles to oral medication administration for children exist, including availability of liquid formulations for precise dosing, patient physical ability to swallow and tolerate, and different oral dosage forms and flavors, and the often unknown safety parameters of inactive excipient ingredients. In order to continue delivering essential therapies to children, these barriers force clinicians to compound or otherwise manipulate medications approved for adult patients in an off-label fashion on a daily basis.
As reviewed by Ivanovska and colleagues, exclusion of pediatric patients from the drug development process is an important contributor to the above-mentioned barriers and is thus being addressed by a variety of worldwide regulations. Included is the Pediatric Research Equity Act in the United States, per which the FDA may require an evaluation of pediatric safety and efficacy for new drug applications to better define appropriate drug dosage and delivery.
Of particular interest to infectious diseases practitioners is the development of novel dispersible tablets, through which many antiretroviral agents may soon be available for administration. Additionally, newly developed mini-tablets as small as 2 mm in diameter, which dissolve very rapidly upon administration, may be acceptable to patients as young as 6 months of age. This new technology could have a significant impact on pharmacy department workload as significant effort is spent compounding very precise individualized doses of oral suspensions.
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