Development and validation of a pediatric dosage form for a commonly used medication

Authors

  • Mrutyunjaya Bhanja
  • Aayush Vaishnaw

Keywords:

Acetaminophen, Ibuprofen, pediatric patients, feverish conditions

Abstract

Pediatric children often have difficulty administering their drugs due to a lack of age-appropriate dosage forms, which can result in inadequate therapeutic effects and poor compliance. The creation and validation of a pediatric dosage form for the regularly administered medications acetaminophen and ibuprofen for feverish conditions is the main focus of this study. By creating a kid-friendly dosage form, the study sought to address important formulation issues such as dose accuracy, taste acceptability, and excipient safety. Using a methodical approach, formulations such liquid suspensions and chewable tablets were developed and optimized after excipients were chosen based on pediatric safety criteria. High-Performance Liquid Chromatography (HPLC) and other analytical techniques were validated to guarantee the formulation's quality properties, including solubility, stability, and homogeneity. Pilot tests assessed the product's usability and palatability in the target population, while stability studies conducted under various conditions determined the product's robustness and shelf life. In comparison to previous choices, the final formulation showed enhanced compliance, stability, and acceptable physicochemical qualities. This study establishes the foundation for future clinical testing and large-scale manufacturing while highlighting the significance of novel techniques in pediatric pharmacotherapy.

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Published

2025-01-28

How to Cite

1.
Bhanja M, Vaishnaw A. Development and validation of a pediatric dosage form for a commonly used medication. J Neonatal Surg [Internet]. 2025Jan.28 [cited 2025Feb.14];14(1S):72-8. Available from: https://jneonatalsurg.com/index.php/jns/article/view/1498

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