Research Article

A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies

Volume: 46 Number: 3 September 1, 2026

A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies

Abstract

Sleep disorders in children can negatively impact their development and quality of life. While melatonin is commonly used to manage these issues, there are no FDA-approved formulations specifically designed for children, and traditional tablet forms can be challenging for these patients. This study aims to develop a patient-friendly melatonin syrup formulation suitable for personalized pediatric therapies. Each teaspoon contains 1.0 mg of melatonin, allowing for flexible and precise dosing customized to individual patient needs. Melatonin content was quantified using a reversed-phase HPLC method with UV/Visible detector (HPLC-UV/Vis) ifadesi ‘with UV/Visible detector (HPLC-UV/Vis) that was developed and validated in line with ICH Q2(R1), demonstrating selectivity, linearity (1.0–30.0 μg/mL; R²=0.999), and intra- and inter-day accuracy and precision within 2%. Stability studies demonstrated that the syrup remains stable and retains its potency for at least seven days at room temperature. This syrup formulation enhances palatability and ease of administration, potentially improving therapeutic outcomes in children with sleep disorders through personalized treatment approaches. The syrup can be easily prepared using commercially available melatonin tablets in hospital pharmacies or home settings, using safe pediatric excipients.

Keywords

Supporting Institution

No

Ethical Statement

No need

Thanks

No

References

  1. 1. Sánchez-Barceló EJ, Mediavilla MD, Reiter RJ. Clinical uses of melatonin in pediatrics. Int J Pediatr. 2011;2011(1):1-9. https://doi.org/10.1155/2011/892624
  2. 2. Glass A, Attrill C, Magee C, Blunden S. Factors associated with melatonin use in child sleep disturbance: A survey of Australian parents. Sleep Med. 2023;107:330-7. https://doi.org/10.1016/j.sleep.2023.04.026.
  3. 3. Lajoinie A, Janiaud P, Henin E, Gleize J-C, Berlion C, Nguyen KA, et al. Assessing the effects of solid versus liquid dosage forms of oral medications on adherence and acceptability in children. The Cochrane Database of Syst Rev. 2017;2017(9). https://doi.org/10.1002/14651858.Cd012783.
  4. 4. Abdülbaki A, Per H. Otizm Spektrum Bozukluğu ve Dikkat Eksikliği ve Hiperaktivite Bozukluğu Olan Çocuklarda Uyku Sağlığı ve Bozuklukları. In: Per H, Arhan E, editors. Çocuklarda Uyku Sağlığı ve Bozuklukları. Ankara: Türkiye Klinikleri; 2020. p. 81-6.
  5. 5. Venables R, Batchelor H, Hodson J, Stirling H, Marriott J. Determination of formulation factors that affect oral medicines acceptability in a domiciliary paediatric population. Int J Pharm. 2015;480(1-2):55-62. https://doi.org/10.1016/j.ijpharm.2015.01.023
  6. 6. Bellis JR, Kirkham JJ, Thiesen S, Conroy EJ, Bracken LE, Mannix HL, et al. Adverse drug reactions and off-label and unlicensed medicines in children: a nested case? Control study of inpatients in a pediatric hospital. BMC Medicine. 2013;11(1):1-8.
  7. 7. Validation Of Analytical Procedures: Text And Methodology Q2(R1): The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2005 [cited 2026 May]. Available from: https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf.
  8. 8. Stability Testing Of New Drug Substances And Products Q1A(R2): The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; 2003 [cited 2026 May]. Available from: https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf

Details

Primary Language

English

Subjects

Pharmaceutical Analytical Chemistry

Journal Section

Research Article

Publication Date

September 1, 2026

Submission Date

August 5, 2026

Acceptance Date

August 12, 2026

Published in Issue

Year 2026 Volume: 46 Number: 3

APA
Nenni, M., Bayraktar Alkan, İ., Demirtürk, E., Kaynak, M. S., Demirkan, K., & Çelebier, M. (2026). A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies. Hacettepe University Journal of the Faculty of Pharmacy, 46(3), 241-249. https://doi.org/10.52794/hujpharm.2012089
AMA
1.Nenni M, Bayraktar Alkan İ, Demirtürk E, Kaynak MS, Demirkan K, Çelebier M. A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies. HUJPHARM. 2026;46(3):241-249. doi:10.52794/hujpharm.2012089
Chicago
Nenni, Merve, İzgi Bayraktar Alkan, Esra Demirtürk, Mustafa Sinan Kaynak, Kutay Demirkan, and Mustafa Çelebier. 2026. “A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies”. Hacettepe University Journal of the Faculty of Pharmacy 46 (3): 241-49. https://doi.org/10.52794/hujpharm.2012089.
EndNote
Nenni M, Bayraktar Alkan İ, Demirtürk E, Kaynak MS, Demirkan K, Çelebier M (September 1, 2026) A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies. Hacettepe University Journal of the Faculty of Pharmacy 46 3 241–249.
IEEE
[1]M. Nenni, İ. Bayraktar Alkan, E. Demirtürk, M. S. Kaynak, K. Demirkan, and M. Çelebier, “A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies”, HUJPHARM, vol. 46, no. 3, pp. 241–249, Sept. 2026, doi: 10.52794/hujpharm.2012089.
ISNAD
Nenni, Merve - Bayraktar Alkan, İzgi - Demirtürk, Esra - Kaynak, Mustafa Sinan - Demirkan, Kutay - Çelebier, Mustafa. “A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies”. Hacettepe University Journal of the Faculty of Pharmacy 46/3 (September 1, 2026): 241-249. https://doi.org/10.52794/hujpharm.2012089.
JAMA
1.Nenni M, Bayraktar Alkan İ, Demirtürk E, Kaynak MS, Demirkan K, Çelebier M. A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies. HUJPHARM. 2026;46:241–249.
MLA
Nenni, Merve, et al. “A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies”. Hacettepe University Journal of the Faculty of Pharmacy, vol. 46, no. 3, Sept. 2026, pp. 241-9, doi:10.52794/hujpharm.2012089.
Vancouver
1.Merve Nenni, İzgi Bayraktar Alkan, Esra Demirtürk, Mustafa Sinan Kaynak, Kutay Demirkan, Mustafa Çelebier. A Simple and Reproducible Melatonin Syrup Formulation for Personalized Pediatric Therapies. HUJPHARM. 2026 Sep. 1;46(3):241-9. doi:10.52794/hujpharm.2012089