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Safety of chewable tablets for children
Theresa M Michele1, Barbara Knorr, Elizabeth B Vadas
1Merck Research Laboratories, Rahway, New Jersey 07065, USA.
Summary
Chewable tablets are a safe and effective pediatric drug formulation for children aged 2 and older. This review found medical issues related to chewable tablets to be extremely rare, making them a well-tolerated alternative.
Area of Science:
- Pediatric Pharmacology
- Drug Formulation Safety
Background:
- Pediatric drug development requires safe and easy-to-use formulations.
- Chewable tablets are common in pediatrics, but their safety data is not widely reviewed.
Purpose of the Study:
- To determine the safety of chewable tablets in pediatric patients.
- To review the published literature on chewable tablet safety in children.
Main Methods:
- Literature search from 1966 to 1999 for safety information on chewable tablets.
- Included human, English-language clinical articles and aspiration case series.
- Supplemented data with Physician's Desk Reference and manufacturer information.
Main Results:
- Over 60 chewable tablet formulations are approved in the U.S.
- Medical issues, including foreign-body injuries, associated with chewable tablets were rare.
- Identified advantages: palatability, stability, precise dosing, portability, and ease of delivery.
Conclusions:
- Chewable tablets are a safe and well-tolerated alternative for pediatric drug delivery.
- Offer significant advantages for children aged 2 years and older.
- Literature supports the use of chewable tablets in pediatric clinical practice.