ReviewInternational journal of general medicine2020
Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations.
Review in International journal of general medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.
- A Systematic Review of the Stability of Extemporaneous Pediatric Oral Formulations.TheScientificWorldJournal · 2021Pooled it
- Use of Topical Analgesics in Neonates.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Enhancing Bioavailability of Ultra-High Concentration Antibody Formulations Using Ionic Liquids.Advanced healthcare materials · 2026Article
- Optimising Formulations for Paediatric Patients with Inherited Metabolic Disorders: The Case Study of Levocarnitine.Pharmaceutical medicine · 2026Review
- Physicochemical evaluation of pediatric liquid medicines in Ghana: implications for cariogenicity and erosive potential.BMC oral health · 2026Article
- Age-Appropriateness of Oral Formulations Authorized for Pediatrics.Pharmaceutical research · 2026Article
- Extemporaneous Formulations for Pediatric Patients: Global Necessities, Challenges and Opportunities.Pharmaceutics · 2026Review
- Three-Dimensional Printing in Paediatrics: Innovative Technology for Manufacturing Patient-Centred Drug Delivery Systems.Pharmaceutics · 2025Review
- Facile Synthesis of FimH Antagonist and Its Analogues: Simple Entry to ComplexACS medicinal chemistry letters · 2024Article
- Characterization of Liquid Dosage Forms of Atenolol and Enalapril Maleate for Oral and Enteral Feeding Administration.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Potentially Harmful Excipients: State of the Art for Oral Liquid Forms Used in Neonatology and Pediatrics Units.Pharmaceutics · 2024Article
- Evaluating the bioequivalence of levetiracetam brand and generic oral tablets available in the Saudi market in vivo.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023Article
- Development of a Hydroxypropyl-β-Cyclodextrin-Based Liquid Formulation for the Oral Administration of Propranolol in Pediatric Therapy.Pharmaceutics · 2023Article
- Neonatal Pharmacokinetics and Biodistribution of Polymeric Nanoparticles and Effect of Surfactant.Pharmaceutics · 2023Article
- Prevalence, Risk, and Challenges of Extemporaneous Preparation for Pediatric Patients in Developing Nations: A Review.Pharmaceutics · 2023Review
- Development of an Oral Liquid Formulation of Nicardipine Hydrochloride Compounded with Simple Excipients for the Treatment of Pediatric Hypertension.Pharmaceutics · 2023Article
- The Current States, Challenges, Ongoing Efforts, and Future Perspectives of Pharmaceutical Excipients in Pediatric Patients in Each Country and Region.Children (Basel, Switzerland) · 2022Review
- Taste Perceptions of Common Pediatric Antibiotic Suspensions and Associated Prescribing Patterns in Medical Residents.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOne of the major challenges in pediatric treatment is the lack of suitable drug preparations specifically designed and marketed for children. Most of the FDA approved drug formulations for adults have not been approved for use in pediatric patients. Shortage of suitable pediatric dosage information often leads health professionals to use adult formulations in an off-label manner. The aim of this work was to review the safety and biopharmaceutical challenges of commonly found excipients in off-label pediatric formulations as well as to show the current progress to alleviate pediatric toxicity related to excipients.
methodsResearch findings and medical case reports were searched from credible sources including Scopus, PubMed, OVID, Google Scholar, Embase, Cochrane Library, and Web of Science.
resultsAs several studies and clinical case reports have revealed, off-label adult formulations usage causes pediatric patients to become exposed to potentially harmful excipients, which are essential components of drug products. In addition to their toxicities, some of the excipients affect the biopharmaceutical property of different drugs. Immature organ and body composition, large body surface area and slower metabolism and elimination capabilities of pediatrics are the main causes of toxicities associated with different excipients. Recent studies have also shown that good progress is being made to develop safe and suitable excipients for pediatric use.
conclusionA risk and benefit assessment should be done before using off-label formulation as excipients cause mild to severe toxicities and biopharmaceutical problems to pediatric patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.