Abstract

Research Article

Oral Suspension as Versatile Galenic Formulation in Pediatry

Mauro Luisetto*, Almukthar N, Edbey K, Mashori GR, Fiazza C, Dona’ l, Cabianca L and Latyshev O

Published: 03 September, 2024 | Volume 8 - Issue 1 | Pages: 091-099

In the last years, there has been an increase in the prescription of drugs in pediatry as a pharmaceutical form of oral suspension. The same is true in commerce there are various producers that provide specific ready-for-use excipients to make more easier to prepare OS in the galenic laboratory. The aim of this work is to verify the advantages of this pharmaceutical form to cover pediatric dosages vs. other forms and also to overcome shortcomings of some crucial registered drugs. In this work scientific literature is reported that also relates to some ready-for-use products as bases-vehicle for suspension and some formulations of interest.

Read Full Article HTML DOI: 10.29328/journal.apps.1001062 Cite this Article Read Full Article PDF

Keywords:

Pediatric galenic formula; Magistral; Oral suspension; Chemico-physical property shortcomings; API; Excipients; Ready-for-use vehicle; Innovations

References

  1. Pharma Central. Pharmaceutical suspending agents: Overview, types, and selection criteria. 2021. Available from: https://pharmacentral.com/learning-hub/technical-guides/pharmaceutical-suspending-agents/
  2. Sheskey PJ, Hancock BC, Moss GP, Goldfarb DJ, editors. Handbook of pharmaceutical excipients. 9th ed. London: Pharmaceutical Press; 2020. Available from: https://www.amazon.in/HANDBOOK-PHARMACEUTICAL-EXCIPIENTS-9ED-2020/dp/0857113755
  3. Morg S. Enhancing pediatric care: The importance of oral suspensions in pediatric drug delivery. Short Communication. 2024;8(1):1-4. Available from: https://www.primescholars.com/articles/enhancing-pediatric-care-the-importance-of-oral-suspensions-in-pediatric-drug-delivery-128106.html
  4. Fallingborg J. Intraluminal pH of the human gastrointestinal tract. Dan Med Bull. 1999 Jun;46(3):183–96. PMID: 10421978. Available from: https://pubmed.ncbi.nlm.nih.gov/10421978/
  5. Allegany Nutrition. The human digestive tract pH range diagram. Available from: https://www.alleganynutrition.com/supporting-pages/the-human-digestive-tract-ph-range-diagram/
  6. Patel VP, Desai TR, Chavda BG, Katira RM. Extemporaneous dosage form for oral liquids. Pharmacophore. 2011;2(2):49-66. Available from: https://pharmacophorejournal.com/storage/models/article/NTH2w2N4ScGJbvhjMITiyuTZwUHwBCnXNqVtWElOnODmDwLffAfAaeabhyFL/extemporaneous-dosage-form-for-oral-liquids.pdf
  7. Nationwide Children’s Hospital. Pharmacy services. Captopril compound sheet. 2020. Available from: https://www.nationwidechildrens.org/specialties/pharmacy-services/compounding-formulas
  8. US Pharmacist. Captopril 1 mg/ml oral solution. Available from: https://www.uspharmacist.com/article/captopril-1-mg-ml-oral-solution
  9. Grissinger M. Life-threatening errors with flecainide suspension in children. Pharm Ther. 2018 May;43(5):258. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5912238/
  10. Sickkids Pharmacy. Propranolol 5 mg/ml oral suspension sheet. Available from: https://www.sickkids.ca/siteassets/care--services/for-health-care-providers/compounding-recipes/propranolol-5mgml-pharmacy-compounding-recipe.pdf
  11. Silva MR, Dysars LP, Santos EP, Ricci E. Preparation of extemporaneous oral liquid in the hospital pharmacy. Braz J Pharm Sci. 2020 Apr 6;56. Available from: http://dx.doi.org/10.1590/s2175-97902019000418358
  12. US Pharmacist. Sildenafil citrate 25 mg/ml oral liquid. 2018. Available from: https://www.uspharmacist.com/article/sildenafil-citrate-25-mg-ml-oral-liquid
  13. Pharmaceutical Society of New Zealand. New Zealand standardised oral formulation batch sheet. Hydrocortisone suspension 1 mg/mL (100 mL). Available from: https://www.psnz.org.nz/Folder?Action=View%20File&Folder_id=189&File=NZSOF%20Hydrocortisone%201mg-1mL.pdf
  14. Svirskis D, Jaffer J, Agarwal P, Khan A, Kaur J, Cheng A, Hanning S. Alcohol-free extemporaneous formulations of furosemide are chemically and physically stable in Ora-Blend products for 30 days. Int J Pharm Compd. 2020 ;24(3):246-251. Available from: https://pubmed.ncbi.nlm.nih.gov/32401745/
  15. Bayview Pharmacy. Aspirin 20 mg/ml oral suspension. Available from: https://www.bayviewrx.com/formulas/Aspirin-20-mg-ml-Oral-Suspension-Heart-Disease-Stroke-Prevention-Rheumatoid-Arthritis-Osteoarthritis-Kawasaki-Disease
  16. Secundum Artem. Stability of extemporaneously prepared oral liquid formulations – Part V. Curr Pract Compounding Inform Pharm. 2010;14(3):1-10. Available from: https://www.padagis.com/wp-content/uploads/2021/10/Sec-Artem-14.3.pdf
  17. SIFAP - Società Italiana Farmacisti Preparatori. Istruzione operativa per l’allestimento di amoxicillina sospensione orale. Available from: https://www.sifoweb.it/images/pdf/attivita/attivita-scientifica/aree_scientifiche/Area_galenica/I.O._Amoxicillina_Sosp.Orale_Rev.01_del_22.05.pdf
  18. Gaikwad SS, Morales JO, Lande NB, Catalán-Figueroa J, Laddha UD, Kshirsagar SJ. Exploring pediatric oral suspension development: Challenges, requirements, and formulation advancements. Int J Pharm. 2024;657:124169. Available from: https://doi.org/10.1016/j.ijpharm.2024.124169
  19. Boscolo O, Perra F, Salvo L, Buontempo F, Lucangioli S. Formulation and stability study of omeprazole oral liquid suspension for pediatric patients. Hosp Pharm. 2020 Oct;55(5):314-322. Published online 2019. Available from: https://doi.org/10.1177%2F0018578719844704
  20. Whaley PA, Voudrie MA, Sorenson B. Stability of omeprazole in SyrSpend SF (reconstituted). Int J Pharm Compd. 2012;16(2):164-166. Available from: https://pubmed.ncbi.nlm.nih.gov/23050328/
  21. Geiger CM, Sorenson B, Whaley P. Stability assessment of 10 active pharmaceutical ingredients compounded in SyrSpend SF. Int J Pharm Compd. 2015;19(5):420-427. Available from: https://pubmed.ncbi.nlm.nih.gov/26775449/
  22. Mansourian M, Dijkers E, Silva CCV, Vale HC. Compatibility of commonly used active pharmaceutical ingredients in a ready-to-use oral suspending vehicle. Pharmaceutics. 2023;15(10):2388. Available from: https://doi.org/10.3390%2Fpharmaceutics15102388
  23. Bobillot M, Delannoy V, Trouillard A, Kinowski JM, Sanchez-Ballester NM, Soulairol I. Potentially harmful excipients: State of the art for oral liquid forms used in neonatology and pediatrics units. Pharmaceutics. 2024;16(1):119. Available from: https://doi.org/10.3390/pharmaceutics16010119
  24. Rouaz K, Chiclana-Rodríguez B, Nardi-Ricart A, Suñé-Pou M, Mercadé-Frutos D, Suñé-Negre JM, et al. Excipients in the pediatric population: A review. Pharmaceutics. 2021;13(3):387. Available from: https://doi.org/10.3390/pharmaceutics13030387
  25. Spennacchio A, Lopalco A, Racaniello GF, Cutrignelli A, la Forgia FM, Fontana S, et al. Mucoadhesive budesonide solution for the treatment of pediatric eosinophilic esophagitis. Pharmaceuticals. 2024;17(5):550. Available from: https://doi.org/10.3390/ph17050550
  26. Italian National Tariffario. Available from: https://www.aifa.gov.it/en/web/guest/tariffe
  27. European Pharmacopoeia. Available from: https://www.edqm.eu/en/european-pharmacopoeia
  28. US Pharmacopoeia. Available from: https://www.usp.org/
  29. British Pharmacopoeia. Available from: https://www.pharmacopoeia.com/
  30. Italian Farmacopea Ufficiale. 12th ed. Rome: 2008. Available from: https://search.worldcat.org/title/849324852
  31. ILM DELLA SALUTE. Italian DM Salute 18.11.2003. Available from: https://www.aifa.gov.it/sites/default/files/DM_Salute_18.11.2003.pdf

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