Ondansetron-Loaded Orodispersible Films: A Fast-Dissolving Drug Delivery Strategy for Antiemetic Therapy

Akash Sadangi; Bishal Kumar Jali; Bishnu Prasad Sahu; Aditya Nahak; Santanu Kumar Hotta; Biswanath Prusty; Jochhana Rani Bhuyan

doi:10.37022/jiaps.v10i2.704

Akash Sadangi Department of Pharmaceutics, College of pharmaceutical sciences Berhampur, Odisha, India
Bishal Kumar Jali Department of Pharmaceutics, College of pharmaceutical sciences Berhampur, Odisha, India
Bishnu Prasad Sahu Department of Pharmaceutics, College of pharmaceutical sciences Berhampur, Odisha, India
Aditya Nahak Department of Pharmaceutics, College of pharmaceutical sciences Berhampur, Odisha, India
Santanu Kumar Hotta Department of Pharmaceutical chemistry, College of pharmaceutical sciences Berhampur, Odisha, India
Biswanath Prusty Department of Pharmaceutical Analysis, College of pharmaceutical sciences Berhampur, Odisha, India
Jochhana Rani Bhuyan Department of Pharmaceutical Analysis, College of pharmaceutical sciences Berhampur, Odisha, India

DOI https://doi.org/10.37022/jiaps.v10i2.704

Abstract

Objective: The objective of the present study was to formulate and evaluate mouth dissolving films (MDFs) of Ondansetron Hydrochloride for the rapid management of nausea and vomiting, especially in pediatric and geriatric patients.Methods: MDFs were prepared by the solvent casting technique using Hydroxypropyl Methylcellulose (HPMC E15) as the film-forming polymer and Polyethylene Glycol 400 (PEG 400) as a plasticizer. Excipients like sucralose, citric acid, and peppermint flavor were incorporated for improved palatability and disintegration. Preformulation studies including UV spectroscopic identification, solubility analysis, melting point determination, and FTIR compatibility were carried out. The films were evaluated for various parameters such as thickness, folding endurance, weight variation, surface pH, disintegration time, drug content uniformity, and in vitro drug release. FTIR spectra were used to assess drug–excipient compatibility.
Results: The formulated films were transparent, smooth, and flexible with rapid disintegration time (20–22 seconds). Drug content was found to be uniform (~99%), and all physical parameters were within acceptable limits. In vitro dissolution studies revealed that over 85% of the drug was released within 5 minutes and ~97% within 10 minutes. FTIR studies confirmed no significant chemical interaction between drug and excipients.
Conclusion: The study demonstrated that mouth dissolving films of Ondansetron Hydrochloride can serve as a promising alternative to conventional oral dosage forms, offering rapid onset of action and ease of administration, particularly for patients with swallowing difficulties.

Keywords: Ondansetron Hydrochloride, Mouth Dissolving Film, HPMC, Solvent Casting, In Vitro Drug Release, FTIR, Pediatric Nausea

Downloads

Download data is not yet available.

References

1. Tomer K, Kumar S, Goyal S, et al. Solubility Enhancement and Formulation Development of an Oral Film of Ondansetron Hydrochloride Monohydrate using Mix-solvency Concept. International Journal of Drug Delivery Technology. 2023;13(4):1575–1581.
2. Aapro M, et al. (2020). Antiemetics: From clinical trials to clinical practice. Support Care Cancer, 28(9), 4015–4023.
3. Desai D, et al. (2022). Role of 5-HT3 antagonists in antiemetic therapy: An updated review. J Clin Pharmacol, 62(1), 12–19.
4. Sharma D, et al. (2021). Formulation challenges of antiemetic therapy in special populations. Asian J Pharm Clin Res, 14(3), 10–15.
5. Dixit RP, Puthli SP. (2021). Oral strip technology: Overview and clinical potential. J Control Release, 330, 1058–1069.
6. Rao M, et al. (2021). Formulation and evaluation of oral dissolving film of ondansetron hydrochloride. Asian J Pharm Clin Res, 14(1), 56–60.
7. Mahajan A, et al. (2023). Development and optimization of fast dissolving films for enhanced patient compliance. Int J Pharm Sci Rev Res, 80(1), 30–36.
8. Jain S, et al. (2022). Novel oral film formulation for pediatric patients: A comprehensive review. Drug Deliv Transl Res, 12(4), 780–793.
9. Bhyan B, et al. (2020). Oral fast dissolving film: Innovations and formulation trends. Int J Pharm Sci Rev Res, 64(2), 12–18.
10. Sharma D, et al. (2012). Fast dissolving drug delivery systems: a review. Int J Pharm Pharm Sci, 4(3), 1–7.
11. Gralla RJ, et al. (1999). Recommendations for antiemetic use. J Clin Oncol, 17(9): 2971.
12. Dixit RP, Puthli SP. (2009). Oral strip technology: overview and future potential. J Control Release, 139(2), 94–107.
13. Khairnar A, et al. (2010). Mouth dissolving films: A novel drug delivery system. Int J PharmTech Res, 2(1), 66–72.
14. Bhyan B, et al. (2012). Oral fast dissolving film: innovations in formulation and technology. Int J Pharm Sci Rev Res, 9(2), 50–57.
15. Singh S, et al. (2015). Formulation and evaluation of mouth dissolving film of ondansetron hydrochloride. Int J Res Pharm Chem, 5(1), 98–103.
16. Rao M, et al. (2021). Formulation and evaluation of oral dissolving film of ondansetron hydrochloride. Asian J Pharm Clin Res, 14(1), 56–60.
17. Arya, A. et al. (2010). Fast Dissolving Oral Films: An Innovative Drug Delivery System and Dosage Form. International Journal of ChemTech Research, 2(1), 576–583.
18. Cilurzo, F. et al. (2008). Fast dissolving films made of maltodextrins. European Journal of Pharmaceutics and Biopharmaceutics, 70(3), 895–900.
19. Indian Pharmacopoeia (2022). Government of India, Ministry of Health and Family Welfare.
20. Nagar, P. et al. (2011). Insights into Polymers: Film Formers in Mouth Dissolving Films. Drug Invention Today, 3(12), 280–289.
21. Borsadia, S., O'Halloran, D., & Rajabi-Siahboomi, A. (2003). Quick-dissolving films – A novel approach to drug delivery. Drug Delivery Technology, 3(3), 63–66.
22. Suresh, B. et al. (2006). Orodispersible tablets: New-fangled drug delivery system – A Review. Indian Drugs, 43(4), 261–272.
23. USP 43–NF 38 (2020). United States Pharmacopeia–National Formulary.
24. Bala, R. et al. (2013). Orally dissolving strips: A new approach to oral drug delivery system. International Journal of Pharmacy and Pharmaceutical Sciences, 5(7), 9–15.