ArticleBMJ paediatrics open2018
Content uniformity of quartered hydrocortisone tablets in comparison with mini-tablets for paediatric dosing.
Article in BMJ paediatrics open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.
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Who cites it
30 citing papers in PubMed.
- Glucocorticoid reduction after starting crinecerfont in pediatric patients with classic congenital adrenal hyperplasia: practical perspectives.The Journal of clinical endocrinology and metabolism · 2026Review
- Dose Accuracy and Content Uniformity of Low-Dose Metoprolol Tablets: 3D Printing Compared with Tablet Splitting in Hospital Pharmacy Setting.Pharmaceutics · 2026Article
- Development of 3D printed dexamethasone chewable tablets for prophylaxis of chemotherapy-induced nausea and vomiting in children.International journal of pharmaceutics: X · 2025Article
- A framework for conducting clinical trials involving 3D printing of medicines at the point-of-care.Drug delivery and translational research · 2025Review
- Life With Classic Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency: Challenges and Burdens.The Journal of clinical endocrinology and metabolism · 2025Article
- Future Directions in the Management of Classic Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency.The Journal of clinical endocrinology and metabolism · 2025Review
- Article
- In Vitro Profile of Hydrocortisone Release from Three-Dimensionally Printed Paediatric Mini-Tablets.Pharmaceutics · 2024Article
- Alkindi Sprinkle for Pediatric Patients With Primary Adrenocortical Insufficiency: A Narrative Review.Cureus · 2024Review
- Practice Variation among Pediatric Endocrinologists in the Dosing of Glucocorticoids in Young Children with Congenital Adrenal Hyperplasia.Children (Basel, Switzerland) · 2023Article
- Manufacturing pharmaceutical mini-tablets for pediatric patients using drop-on-demand printing.International journal of pharmaceutics · 2023Article
- Interpretation of Steroid Biomarkers in 21-Hydroxylase Deficiency and Their Use in Disease Management.The Journal of clinical endocrinology and metabolism · 2023Review
- Adrenal crisis in infants and young children with adrenal insufficiency: Management and prevention.Frontiers in endocrinology · 2023Article
- Development and evaluation of an assessment of the age-appropriateness/inappropriateness of formulations used in children.International journal of clinical pharmacy · 2022Article
- Identifying and addressing pill aversion in adults without physiological-related dysphagia: A narrative review.British journal of clinical pharmacology · 2022Review
- Evaluation of the Effect of Ethyl Acrylate-Methyl Methacrylate Copolymer in Racecadotril Dispersible Tablet.Turkish journal of pharmaceutical sciences · 2022Article
- Drug-handling problems and expectations of the ideal pediatric drug-reported by children and their parents.European journal of pediatrics · 2022Article
- Bone Age Maturation and Growth Outcomes in Young Children with CAH Treated with Hydrocortisone Suspension.Journal of the Endocrine Society · 2022Article
- Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Stability of Hydrocortisone in Oral Powder Form Compounded for Pediatric Patients in Japan.Pharmaceutics · 2021Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesChildren requiring cortisol replacement therapy are often prescribed hydrocortisone doses of 2.5 mg, but as this is commercially unavailable 10 mg tablets, with functional break lines, are split commonly in an attempt to deliver the correct dose. This study aimed to determine the dose variation obtained from quartered hydrocortisone tablets when different operators performed the splitting procedure and to ascertain whether better uniformity could be attained from mini-tablets as an alternative formulation.
methodsHydrocortisone 10 mg tablets were quartered by four different operators using a standard pill splitter. Hydrocortisone 2.5 mg mini-tablets (3 mm diameter) were formulated using a wet granulation method and manufactured using a high-speed rotary press simulator. The weight and content uniformity of the quartered tablets and mini-tablets were assessed according to pharmacopoeial standards. The physical strength and dissolution profiles of the mini-tablets were also determined.
resultsMore than half of all quartered 10 mg tablets were outside of the ±10% of the stated US Pharmacopoeia hydrocortisone content (mean 2.34 mg, SD 0.36, coefficient of variation (CV) 15.18%) and more than 40% of the quartered tablets were outside the European Pharmacopoeia weight variation. Robust mini-tablets (tensile strengths of >4 MPa) were produced successfully. The mini-tablets passed the pharmacopoeial weight and content uniformity requirements (mean 2.54 mg, SD 0.04, CV 1.72%) and drug release criteria during in vitro dissolution testing.
conclusionThis study confirmed that quartering 10 mg hydrocortisone tablets produces unacceptable dose variations and that it is feasible to produce 3 mm mini-tablets containing more accurate doses for paediatric patients.
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