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EVALUATION OF CASES WITH THE USAGE OF COMMERCIALLY AVAILABLE TABLETS IN THE PEDIATRIC FORMULA
Insights
Pediatric drug dosing often requires pharmacists to prepare customized powders from adult tablets when appropriate pediatric formulations are unavailable. This practice ensures safe and effective medication administration for children, even when specific pediatric doses are missing from the market.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Pharmaceutical Compounding
Background:
- Lack of commercially available pediatric-specific drug formulations and doses necessitates the use of adult medications in children.
- Physicians often prescribe adult-formulated drugs for pediatric patients due to unavailability of suitable pediatric alternatives.
- This practice requires careful consideration of drug form, dosage, and administration route for safe and effective pediatric treatment.
Purpose of the Study:
- To evaluate the practice of using commercially available adult tablet-formulated medicinal products for pediatric use.
- To assess the preparation and legitimacy of compounded pediatric drug forms derived from adult medications.
- To analyze prescribing patterns and the impact of Summary of Product Characteristics (SmPC) information on pediatric drug administration.
Main Methods:
- Retrospective analysis of 154 prescriptions filled in community pharmacies in Warminsko-Mazurskie Voivodeship in 2011.
- Evaluation of compounded pediatric drug forms prepared from adult tablets and capsules, specifically divided powders in starch capsules.
- Categorization of prescribed medications into six groups: antihypertensives, heart failure drugs, anti-clotting agents, prokinetics, antibacterials, and dopaminergics.
Main Results:
- A total of 5805 divided powders in starch capsules were prepared from adult tablets and capsules for pediatric use.
- The transformation of oral tablets into divided powders for internal use did not alter the administration method.
- When SmPC provided pediatric indications and dosage, administration followed registered uses; absence of this information led to off-label use.
Conclusions:
- Compounding adult medications into pediatric-friendly forms, such as divided powders, is a viable solution when specific pediatric doses are unavailable.
- The availability of clear pediatric dosing and indication information in the SmPC is crucial for ensuring appropriate and safe medication use in children.
- This study highlights the importance of pharmaceutical compounding services in addressing medication gaps in pediatric populations.
Abstract:
Lack of availability, of either the medicinal product intended to be used for children, or such in a dose which is fitting for the individual child's needs, results in physicians administering medicines meant for the adult. The target of the thesis was to evaluate the cases with the usage of commercially avaible conventional tablet-formulated medicinal products intended for the adult in the pediatric formula. The subjects of the evaluation were the form of the pediatric drug, prepared from commercially available tablets and capsules, as well as the legitimacy of their usage in the treatment of the pediatric population. One hundred and fifty-four prescriptions filled in community pharmacies of Warminsko-Mazurskie Voivodeship in 2011 were chosen. A total of 5805 divided powders in starch capsules were prepared. The prescribing practice included 6 groups of manufactured medicinal products in the form of conventional tablets, containing as follows: anti-hypertensive medicines (ACE inhibitors--enalapril, captopril, ramipril, loop diuretics--furosemide, potassium sparing diuretics--spironolactone, β-adrenolytics--propranolol, α- and β-adrenolytics--carvedilol), medicines for heart failure (foxglove glycosides--digoxin, methyldigoxin), anti-clotting medicines (acetylsalicylic acid), peristalsis stimulating agents (metoclopramide), antibacterial medicines (furagin), and dopaminergic (carbidopa-levodopa). The only compounded forms ordered by the physicians were divided powders for an internal use. Starch capsules for powder preparation provided the only 'package' for the dose of the compounded powder, which after pouring, solving or suspending in water was administered to children. Such a shift of the form, between an oral tablet and divided powder for an internal use, did not cause a change in the method of administration. The information on indications and the way of dosage for children, inserted in the Summary of Product Characteristics, enables the administration which follows the registered indications, despite the shortage of an appropriate dose in the pharmaceutical market. In contrast, an absence of the information regarding the indications and a dosage for children in the Summary of Product Characteristic, results in an off-label administration, in case of a child.
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