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Published on: March 11, 2017
Assessment of Sorbitol as a Pharmaceutical Excipient in Oral Liquid Pediatric Formulations Submitted to the U.S. FDA
Gelareh A Abulwerdi1, Brianna Cote1, Susan Abdel-Rahman1
1Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Insights
Sorbitol, a common excipient in pediatric liquid medicines, can reduce drug absorption. This study found high daily sorbitol intake from some pediatric drugs, particularly corticosteroids, necessitating further investigation into its impact.
Area of Science:
- Pharmacology and Pharmaceutical Sciences
- Pediatric Drug Development
- Drug Formulation and Excipient Safety
Background:
- Sorbitol is a widely used excipient in pediatric oral liquid formulations.
- Previous research indicates sorbitol can decrease the bioavailability of co-administered medications.
- The extent of sorbitol use and daily intake in pediatric formulations remains underexplored.
Purpose of the Study:
- To quantify the prevalence of sorbitol as an excipient in pediatric oral liquid medications.
- To estimate the maximum daily sorbitol consumption from individual pediatric drug products.
- To assess the potential risks associated with sorbitol in pediatric polypharmacy.
Main Methods:
- A compilation of drug products containing sorbitol was sourced from an Interagency Agreement between NICHD and FDA.
- Products with oral liquid formulations intended for pediatric use were selected for analysis.
- Maximum daily sorbitol amounts were categorized into four levels (0-3) based on consumption thresholds.
Main Results:
- Sorbitol content varied from 0.06% to 45.7% (w/v) across various therapeutic classes, with nervous system disorder drugs being most common.
- Corticosteroid formulations exhibited the highest daily sorbitol exposure, exceeding 45 grams.
- 11.5% of products fell into the highest sorbitol intake category (Level 3), while 42% were in the lowest (Level 0).
Conclusions:
- A significant proportion of pediatric oral liquid formulations contain substantial amounts of sorbitol.
- High daily sorbitol intake, especially from corticosteroids, warrants attention due to potential drug interaction risks.
- Further research is crucial to understand the clinical impact of sorbitol in pediatric polypharmacy and establish safe usage guidelines.
Abstract:
Sorbitol is a commonly used excipient in pediatric oral liquid formulations. Previous research revealed that sorbitol as an excipient can diminish the bioavailability of concomitant drugs. The reported cases and amount of sorbitol in pediatric formulations has not been explored, thus the aims of this study were to (1) examine the number of reports of sorbitol as an excipient in orally administered drugs with liquid formulations used in pediatrics, and (2) estimate the maximum amount of sorbitol that may be consumed per day for each drug. A compilation of drug products containing sorbitol as an excipient was retrieved from the Interagency Agreement between the National Institute of Child Health and Human Development (NICHD) and the Food and Drug Administration (FDA), and products with oral liquid formulations were selected. Maximum daily sorbitol amount was categorized into level 0 (< 3,200 mg), level 1 (3,200 mg to < 10,200 mg), level 2 (10,200 mg to < 13,400 mg), and level 3 (≥ 13,400 mg). Results indicated that sorbitol amount ranged between 0.06% and 45.7% weight to volume (w/v) across several therapeutic areas with the most prevalent being drugs intended for nervous system disorders. Corticosteroid drug products had the highest daily exposures to sorbitol, with amounts surpassing 45 grams. Percentages of products at levels 3, 2, 1 and 0 were 11.5%, 7.1%, 39.3%, and 42%, respectively. The potential impact of sorbitol content in pediatric formulations and the best practices for its use in pediatric polypharmacy needs to be further investigated.
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