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Year 2024, Volume: 28 Issue: 5, 1791 - 1799, 28.06.2025

Duygu Eneş , Bilge Başak Fidan , Ozan Kaplan , Ayşegül Doğan , Sacide Altınöz , Mustafa Çelebier , Mustafa Sinan Kaynak

https://doi.org/10.12991/jrespharm.1691101

Abstract

References

  • [1] Ramamoorthy S, Cidlowski JA. Corticosteroids: Mechanisms of Action in Health and Disease. Rheum Dis Clin North Am. 2016; 42(1): 15-31. https://doi.org/10.1016/j.rdc.2015.08.002
  • [2] Kino T, Burd I, Segars JH. Dexamethasone for severe COVID-19: how does it work at cellular and molecular levels? Int. J. Mol. Sci. 2021; 22(13): 6764.https://doi.org/10.3390/ijms22136764
  • [3] Kadmiel M, Cidlowski JA. Glucocorticoid receptor signaling in health and disease. Trends Pharmacol. Sci. 2013; 34(9): 518-530. https://doi.org/10.1016/j.tips.2013.07.003
  • [4] Santoveña-Estévez A, Dorta-Vera D, González-García I, Suárez-González J, Teigell-Pérez N, B Fariña F. Safe use of Dexamethasone in pediatrics: Design and evaluation of a novel stable oral suspension. Pharm. Technol. Hosp. Pharm.2018; 3(2): 59-70. https://doi.org/10.1515/pthp-2018-0003
  • [5] Ferrara G, Petrillo MG, Giani T, Marrani E, Filippeschi C, Oranges T, Simonini G, Cimaz R. Clinical use and molecular action of corticosteroids in the pediatric age. Int. J. Mol. Sci. 2019; 20(2):444. https://doi.org/10.3390/ijms20020444
  • [6] Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001; 139(1): 20-26. https://doi.org/10.1067/mpd.2001.115021
  • [7] Meyer JS, Riese J, Biondi E. Is dexamethasone an effective alternative to oral prednisone in the treatment of pediatric asthma exacerbations?.Hosp Pediatr. 2014; 4(3): 172-180. https://doi.org/10.1542/hpeds.2013-0088
  • [8] Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014; 133(3): 493-499. https://doi.org/10.1542/peds.2013-2273
  • [9] Sanders RJ, Cox C, Phelps DL, Sinkin RA. Two doses of early intravenous dexamethasone for the prevention of bronchopulmonary dysplasia in babies with respiratory distress syndrome. Pediatr. Res. 1994; 36(1): 122-128. https://doi.org/10.1203/00006450-199407001-00022
  • [10] Jobe AH. Postnatal corticosteroids for bronchopulmonary dysplasia. Clin Perinatol. 2009; 36(1): 177-188. https://doi.org/10.1016/j.clp.2008.09.016
  • [11] Parker CM, Cooper MN. Prednisolone versus dexamethasone for croup: a randomized controlled trial. Pediatrics. 2019; 144(3): e20183772.https:/doi.org/10.1542/peds.2018-3772
  • [12] Grier DG, Halliday HL. Corticosteroids in the prevention and management of bronchopulmonary dysplasia. Semin. Neonatol. 2003; 8(1): 83-91. https://doi.org/10.1016/S1084-2756(02)00189-6
  • [13] McCallister A, So TY, Stewart J. Evaluation of the Efficacy of a Onetime Injectable DexamethasoneAdministered Orally in the Pediatric Emergency Department for Asthma Exacerbation. J Pediatr Pharmacol Ther. 2017; 22(5): 326-331. https://doi.org/10.5863/1551-6776-22.5.326
  • [14] Ensom MH, Décarie D. Dexamethasone 1 mg/mL Suspension Prepared from Crushed Tablets: Stability in Glass and Plastic Bottles and Plastic Syringes. Can J Hosp Pharm. 2016; 69(1): 49-51. https://doi.org/10.4212/cjhp.v69i1.1524
  • [15] Binson G, Venisse N, Bacle A, Beuzit K, Dupuis A. Preparation and physico-chemical stability of dexamethasone oral suspension. Pharm. Technol. Hosp. Pharm. 2017; 2(4): 193-201. https://doi.org/10.1515/pthp-2017-0029
  • [16] Chou JWL, Decarie D, Dumont RA, Ensom MHH. Stability of dexamethasone in extemporaneously prepared oral suspensions. Can J Hosp Pharm. 2001; 54(2): 97-103.https://doi.org/10.4212/cjhp.v54i2.634
  • [17] Rowe RC, Sheskey P, Quinn M. Handbook of pharmaceutical excipients. Libros Digitales-Pharmaceutical Press, USA 2009.
  • [18] ICH. Validation of analytical procedures: Text and Methodology Q2(R1). Harmonized Tripartite Guideline, 2005.
  • [19] Martindale The Complete Drug Reference. Thirty-sixth ed. 2009, London, UK: Pharmaceutical Press.
  • [20] Guideline, I., Stability testing of new drug substances and products. Q1A (R2), current step, 2003. 4: p. 1-24.
  • [21] Devi GR, Prathyusha V, Shanthakumari K, Rahaman SA. Development and validation of UV-Spectrophotometric method for the estimation of dexamethasone sodium phosphate in bulk and pharmaceutical dosage form. Indo Am. J. Pharm. Res. 2013; 3(7): 5055-5061.
  • [22] Sversut RA, Vieiraa JC, Rosaa AM, Singhb AK, Amaralc MS, Kassaba NM. Improved UV Spectrophotometric Method for Precise. Efficient and Selective Determination of Dexamethasone in Pharmaceutical Dosage Forms. Orbital: Electron. J. Chem. 2015; 7(1): 5-9.:
  • [23] Buga I, Uzoma JI, Reindel K, Rashid K, Diep T, McCartan P, Zhao F. Physical and Chemical Stability of Dexamethasone Sodium Phosphate in Intravenous Admixtures Used to Prevent Chemotherapy-Induced Nausea and Vomiting. Hosp. Pharm. 2021; 56(4): 215-220.https://doi.org/10.1177/0018578719888912

Development and UV-VIS Spectrophotometric analysis of an ease-of-use pediatric oral solution of dexamethasone for personalized therapies

Year 2024, Volume: 28 Issue: 5, 1791 - 1799, 28.06.2025

Duygu Eneş , Bilge Başak Fidan , Ozan Kaplan , Ayşegül Doğan , Sacide Altınöz , Mustafa Çelebier , Mustafa Sinan Kaynak

https://doi.org/10.12991/jrespharm.1691101

Abstract

The usage of dexamethasone for pediatric applications is a well-known issue. In the present study, we developed an oral dexamethasone solution formulation especially aimed for dose-dependent personalized therapies and having excipients known as not harmful to be safely used in pediatrics. The aim of this study was to prepare an easy-of- use pediatric oral solution of dexamethasone and develop an UV/VIS Spectrophotometric method for the evaluation of the stability and quality control of the developed formulation. The primary source of dexamethasone for preparation of the oral pediatric solution was the dexamethasone one-time injectable solutions. This allowed the formulation to be easily prepared in basic laboratory conditions. Dexamethasone content and stability of the formulation were ensured by quantification using the developed UV/VIS Spectrophotometric method validated based on ICH Q2 (R1) guidelines. Simple, fast, reliable, and validated spectrophotometric analysis of dexamethasone was carried out at 269 nm wavelength and the method was linear in a range of 1.00 to 50.00 μg mL–1.The developed formulation was stable at 4 °C at least for three weeks when protected from daylight. The other stability conditions (ambient temperature and -20 °C) were also evaluated for the assays. Although the methodology used in this study contains simple processes which can be easily adapted to basic laboratory conditions, the results were satisfactory to prepare an ease-of-use pediatric oral solution of dexamethasone for personalized medicine. The validated UV/VIS Spectrophotometric method was selective for the formulation and easily applied for the quality control and stability studies of the samples. Such formulations could be helpful for health professionals in managing real-life corticosteroid treatment application problems especially for pediatrics in hospital pharmacy.

Keywords

Dexamethasone pediatrics personalized medicine UV-VIS spectroptrophotometry oral solution

References

  • [1] Ramamoorthy S, Cidlowski JA. Corticosteroids: Mechanisms of Action in Health and Disease. Rheum Dis Clin North Am. 2016; 42(1): 15-31. https://doi.org/10.1016/j.rdc.2015.08.002
  • [2] Kino T, Burd I, Segars JH. Dexamethasone for severe COVID-19: how does it work at cellular and molecular levels? Int. J. Mol. Sci. 2021; 22(13): 6764.https://doi.org/10.3390/ijms22136764
  • [3] Kadmiel M, Cidlowski JA. Glucocorticoid receptor signaling in health and disease. Trends Pharmacol. Sci. 2013; 34(9): 518-530. https://doi.org/10.1016/j.tips.2013.07.003
  • [4] Santoveña-Estévez A, Dorta-Vera D, González-García I, Suárez-González J, Teigell-Pérez N, B Fariña F. Safe use of Dexamethasone in pediatrics: Design and evaluation of a novel stable oral suspension. Pharm. Technol. Hosp. Pharm.2018; 3(2): 59-70. https://doi.org/10.1515/pthp-2018-0003
  • [5] Ferrara G, Petrillo MG, Giani T, Marrani E, Filippeschi C, Oranges T, Simonini G, Cimaz R. Clinical use and molecular action of corticosteroids in the pediatric age. Int. J. Mol. Sci. 2019; 20(2):444. https://doi.org/10.3390/ijms20020444
  • [6] Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001; 139(1): 20-26. https://doi.org/10.1067/mpd.2001.115021
  • [7] Meyer JS, Riese J, Biondi E. Is dexamethasone an effective alternative to oral prednisone in the treatment of pediatric asthma exacerbations?.Hosp Pediatr. 2014; 4(3): 172-180. https://doi.org/10.1542/hpeds.2013-0088
  • [8] Keeney GE, Gray MP, Morrison AK, Levas MN, Kessler EA, Hill GD, Gorelick MH, Jackson JL. Dexamethasone for acute asthma exacerbations in children: a meta-analysis. Pediatrics. 2014; 133(3): 493-499. https://doi.org/10.1542/peds.2013-2273
  • [9] Sanders RJ, Cox C, Phelps DL, Sinkin RA. Two doses of early intravenous dexamethasone for the prevention of bronchopulmonary dysplasia in babies with respiratory distress syndrome. Pediatr. Res. 1994; 36(1): 122-128. https://doi.org/10.1203/00006450-199407001-00022
  • [10] Jobe AH. Postnatal corticosteroids for bronchopulmonary dysplasia. Clin Perinatol. 2009; 36(1): 177-188. https://doi.org/10.1016/j.clp.2008.09.016
  • [11] Parker CM, Cooper MN. Prednisolone versus dexamethasone for croup: a randomized controlled trial. Pediatrics. 2019; 144(3): e20183772.https:/doi.org/10.1542/peds.2018-3772
  • [12] Grier DG, Halliday HL. Corticosteroids in the prevention and management of bronchopulmonary dysplasia. Semin. Neonatol. 2003; 8(1): 83-91. https://doi.org/10.1016/S1084-2756(02)00189-6
  • [13] McCallister A, So TY, Stewart J. Evaluation of the Efficacy of a Onetime Injectable DexamethasoneAdministered Orally in the Pediatric Emergency Department for Asthma Exacerbation. J Pediatr Pharmacol Ther. 2017; 22(5): 326-331. https://doi.org/10.5863/1551-6776-22.5.326
  • [14] Ensom MH, Décarie D. Dexamethasone 1 mg/mL Suspension Prepared from Crushed Tablets: Stability in Glass and Plastic Bottles and Plastic Syringes. Can J Hosp Pharm. 2016; 69(1): 49-51. https://doi.org/10.4212/cjhp.v69i1.1524
  • [15] Binson G, Venisse N, Bacle A, Beuzit K, Dupuis A. Preparation and physico-chemical stability of dexamethasone oral suspension. Pharm. Technol. Hosp. Pharm. 2017; 2(4): 193-201. https://doi.org/10.1515/pthp-2017-0029
  • [16] Chou JWL, Decarie D, Dumont RA, Ensom MHH. Stability of dexamethasone in extemporaneously prepared oral suspensions. Can J Hosp Pharm. 2001; 54(2): 97-103.https://doi.org/10.4212/cjhp.v54i2.634
  • [17] Rowe RC, Sheskey P, Quinn M. Handbook of pharmaceutical excipients. Libros Digitales-Pharmaceutical Press, USA 2009.
  • [18] ICH. Validation of analytical procedures: Text and Methodology Q2(R1). Harmonized Tripartite Guideline, 2005.
  • [19] Martindale The Complete Drug Reference. Thirty-sixth ed. 2009, London, UK: Pharmaceutical Press.
  • [20] Guideline, I., Stability testing of new drug substances and products. Q1A (R2), current step, 2003. 4: p. 1-24.
  • [21] Devi GR, Prathyusha V, Shanthakumari K, Rahaman SA. Development and validation of UV-Spectrophotometric method for the estimation of dexamethasone sodium phosphate in bulk and pharmaceutical dosage form. Indo Am. J. Pharm. Res. 2013; 3(7): 5055-5061.
  • [22] Sversut RA, Vieiraa JC, Rosaa AM, Singhb AK, Amaralc MS, Kassaba NM. Improved UV Spectrophotometric Method for Precise. Efficient and Selective Determination of Dexamethasone in Pharmaceutical Dosage Forms. Orbital: Electron. J. Chem. 2015; 7(1): 5-9.:
  • [23] Buga I, Uzoma JI, Reindel K, Rashid K, Diep T, McCartan P, Zhao F. Physical and Chemical Stability of Dexamethasone Sodium Phosphate in Intravenous Admixtures Used to Prevent Chemotherapy-Induced Nausea and Vomiting. Hosp. Pharm. 2021; 56(4): 215-220.https://doi.org/10.1177/0018578719888912
There are 23 citations in total.

Details

Primary Language English
Subjects Pharmaceutical Analytical Chemistry
Journal Section Articles
Authors

Duygu Eneş 0000-0002-8908-3177

Bilge Başak Fidan 0000-0002-0213-5887

Ozan Kaplan 0000-0001-7429-9349

Ayşegül Doğan 0000-0002-5828-4697

Sacide Altınöz 0000-0003-2864-9218

Mustafa Çelebier 0000-0001-7712-5512

Mustafa Sinan Kaynak

Publication Date June 28, 2025
Published in Issue Year 2024 Volume: 28 Issue: 5

Cite

APA Eneş, D., Fidan, B. B., Kaplan, O., Doğan, A., et al. (2025). Development and UV-VIS Spectrophotometric analysis of an ease-of-use pediatric oral solution of dexamethasone for personalized therapies. Journal of Research in Pharmacy, 28(5), 1791-1799. https://doi.org/10.12991/jrespharm.1691101
AMA Eneş D, Fidan BB, Kaplan O, Doğan A, Altınöz S, Çelebier M, Kaynak MS. Development and UV-VIS Spectrophotometric analysis of an ease-of-use pediatric oral solution of dexamethasone for personalized therapies. J. Res. Pharm. July 2025;28(5):1791-1799. doi:10.12991/jrespharm.1691101
Chicago Eneş, Duygu, Bilge Başak Fidan, Ozan Kaplan, Ayşegül Doğan, Sacide Altınöz, Mustafa Çelebier, and Mustafa Sinan Kaynak. “Development and UV-VIS Spectrophotometric Analysis of an Ease-of-Use Pediatric Oral Solution of Dexamethasone for Personalized Therapies”. Journal of Research in Pharmacy 28, no. 5 (July 2025): 1791-99. https://doi.org/10.12991/jrespharm.1691101.
EndNote Eneş D, Fidan BB, Kaplan O, Doğan A, Altınöz S, Çelebier M, Kaynak MS (July 1, 2025) Development and UV-VIS Spectrophotometric analysis of an ease-of-use pediatric oral solution of dexamethasone for personalized therapies. Journal of Research in Pharmacy 28 5 1791–1799.
IEEE D. Eneş, B. B. Fidan, O. Kaplan, A. Doğan, S. Altınöz, M. Çelebier, and M. S. Kaynak, “Development and UV-VIS Spectrophotometric analysis of an ease-of-use pediatric oral solution of dexamethasone for personalized therapies”, J. Res. Pharm., vol. 28, no. 5, pp. 1791–1799, 2025, doi: 10.12991/jrespharm.1691101.
ISNAD Eneş, Duygu et al. “Development and UV-VIS Spectrophotometric Analysis of an Ease-of-Use Pediatric Oral Solution of Dexamethasone for Personalized Therapies”. Journal of Research in Pharmacy 28/5 (July 2025), 1791-1799. https://doi.org/10.12991/jrespharm.1691101.
JAMA Eneş D, Fidan BB, Kaplan O, Doğan A, Altınöz S, Çelebier M, Kaynak MS. Development and UV-VIS Spectrophotometric analysis of an ease-of-use pediatric oral solution of dexamethasone for personalized therapies. J. Res. Pharm. 2025;28:1791–1799.
MLA Eneş, Duygu et al. “Development and UV-VIS Spectrophotometric Analysis of an Ease-of-Use Pediatric Oral Solution of Dexamethasone for Personalized Therapies”. Journal of Research in Pharmacy, vol. 28, no. 5, 2025, pp. 1791-9, doi:10.12991/jrespharm.1691101.
Vancouver Eneş D, Fidan BB, Kaplan O, Doğan A, Altınöz S, Çelebier M, Kaynak MS. Development and UV-VIS Spectrophotometric analysis of an ease-of-use pediatric oral solution of dexamethasone for personalized therapies. J. Res. Pharm. 2025;28(5):1791-9.