ArticlePharmaceutics2019
Preparation and Physicochemical Stability of Liquid Oral Dosage Forms Free of Potentially Harmful Excipient Designed for Pediatric Patients.
Article in Pharmaceutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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
10 citing papers in PubMed, 27 citations in OpenAlex.
- Model-Informed Dose Optimization of Spironolactone in Neonates and Infants.Pharmaceuticals (Basel, Switzerland) · 2025Article
- A review of precision medicine in developing pharmaceutical products: Perspectives and opportunities.International journal of pharmaceutics · 2025Review
- Characterization of Liquid Dosage Forms of Atenolol and Enalapril Maleate for Oral and Enteral Feeding Administration.Pharmaceuticals (Basel, Switzerland) · 2024Article
- The Development of an Oral Solution Containing Nirmatrelvir and Ritonavir and Assessment of Its Pharmacokinetics and Stability.Pharmaceutics · 2024Article
- Stability of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient's Safety-A Narrative Review.Pharmaceutics · 2023Review
- Assessment of Knowledge, Attitudes, and Practices of Traditional Healers toward Dosage Forms and Routes of Administration: A Cross-Sectional Study in Ethiopia.Evidence-based complementary and alternative medicine : eCAM · 2023Article
- Accuracy of Dose Administered to Children Using Off-Labelled or Unlicensed Oral Dosage Forms.Pharmaceutics · 2021Article
- Oral delivery of peptide therapeutics in infants: Challenges and opportunities.Advanced drug delivery reviews · 2021Review
- Safety and Biopharmaceutical Challenges of Excipients in Off-Label Pediatric Formulations.International journal of general medicine · 2020Review
- Spotlight on Spironolactone Oral Suspension for the Treatment of Heart Failure: Focus on Patient Selection and Perspectives.Vascular health and risk management · 2019Review
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Dexamethasone, hydrochlorothiazide, spironolactone, and phenytoin are commonly used in neonates, but no age-appropriate formulation containing these active pharmaceutical ingredients (APIs) is commercially available. Thus, pharmaceutical compounding of the liquid oral dosage form is required to enable newborn administration. A problem common to the compounded preparations described in the literature is that they include potentially harmful excipients (PHEs). Therefore, the aim of this study was to evaluate the feasibility of compounding oral liquid dosage forms free of PHE, containing dexamethasone, hydrochlorothiazide, phenytoin, or spironolactone and to assess their physicochemical stability. Due to the poor water solubility of the targeted APIs, oral suspensions were compounded using Syrspend® SF-PH4 Dry, a suspending vehicle free of PHE. Four HPLC coupled to UV spectrometry (HPLC-UV) stability-indicating methods were developed and validated according to international guidelines to assay the strength of the targeted APIs. Whatever storage condition was used (5 ± 3 °C or 22 ± 4 °C), no significant degradation of API occurred in compounded oral suspensions. Overall, the results attest to the physical and chemical stability of the four oral liquid dosage forms over 60 days under regular storage temperatures. Finally, the use of the proposed oral suspensions provides a reliable solution to reduce the exposure of children to potentially harmful excipients.
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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.