AI Article Synopsis
- - The study examines how developmental changes in children affect the absorption of fluconazole, a medication, by comparing key parameters like gastric pH and drug metabolism between adults and kids.
- - Fluconazole is shown to have good solubility and rapid absorption in children, with a low risk of altered drug absorption due to differences in physiological factors, suggesting that the drug is safely effective in the paediatric population.
- - The findings support extending the biowaiver for fluconazole from adults to children, as it meets the criteria for high solubility and permeability, and has a good safety profile in both age groups if proper guidelines are followed.
Article Abstract
Objectives: The paediatric population undergoes developmental changes in gastric pH, gastric emptying, intestinal transit time, membrane permeability, protein binding, body water, distribution and metabolism. It is widely recognised that changes in these parameters may result in an alteration of the plasma profile and thus in key bioequivalence parameters such as Cmax (maximum plasma concentration of drug) and area under the plasma concentration vs time profile curve. The aim of this work is to assess the risk of extending the biowaiver for immediate release dosage formulations of fluconazole from the adult to the paediatric population.
Methods And Key Findings: Fluconazole exhibits good solubility and very rapid dissolution characteristics in various pH media. The absorption of fluconazole in children is known to be complete (over 90%) and not impaired by elevated pH, which is prevalent during the early days of life. Dose numbers calculated using body surface area are less than 1. Therefore, the risk to drug absorption due to differences in gastric pH, gastric emptying, intestinal transit, membrane permeability and metabolising enzymes between adults and children is considered low.
Conclusions: Thus, it can be safely concluded that fluconazole meets highly soluble and highly permeable criteria in the paediatric population and can be allocated to class 1 of the Biopharmaceutics Classification System (BCS) for this population as well as in adults. Additionally, fluconazole has an excellent safety profile in children, similar to that in adults. The BCS-based biowaiver claimed in adults can be safely extended to the paediatric population provided that the requirements in excipient selection and dissolution profile comparison using BCS-based dissolution conditions as stated in the biowaiver monograph for fluconazole immediate release dosage forms in adults are fulfilled.
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| http://dx.doi.org/10.1111/jphp.12411 | DOI Listing |
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