Author(s):
Karan K. Lokhande, Dhanashree P. Sanap, Kisan R. Jadhav
Email(s):
dhanashree.sanap@bvcop.in
DOI:
10.52711/0974-360X.2025.00617 
Address:
Karan K. Lokhande, Dhanashree P. Sanap*, Kisan R. Jadhav
Bharati Vidyapeeth’s College of Pharmacy, Sector-8, CBD Belapur, Navi Mumbai 400614, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 9,
Year - 2025
ABSTRACT:
The present study aimed to develop an ondansetron microemulsion and incorporate it into an oral thin film. In the design of experiments, a central composite design was utilized to optimize the formulations, focusing on the concentrations of hydroxypropyl methylcellulose (HPMC K15) (X1) and HPMC K4 (X2) as independent variables. The optimized batch designated as FB-1, exhibited a drug content of 101±0.5%, a film weight of 49.8±0.8mg, a minimum disintegration time of 47±0.05 seconds, a thickness of 0.12±0.2mm, and a pH of 6.8 ±0.05, along with desirable mechanical properties, including a tensile strength of 150g/cm². Characterization of the optimized film includes FTIR, DSC for drug interaction, SEM for morphology, and evaluations of in vitro drug release and ondansetron loading effectiveness. The optimized batch exhibited a remarkable drug release profile, achieving approximately 88.83% release at the 5 min mark. This rapid dissolution continued, surpassing 95 % within the first 10 min, demonstrating the highest dissolution rate observed. The developed ME-loaded OTFs significantly enhanced drug release compared to the marketed film Vomikind-Fast strip 4mg (Mankind Pharma) showed a 64% release at 5 min and 65% at 10min, while Emefilm 4mg (Delvin Formulations) had a release rate of 64% at 5 min and 68% at 10min. By improving the solubility and bioavailability of ondansetron, this microemulsion-embedded film technology offers a dosage form that is both easy to administer and improves compliance among patients.
Cite this article:
Karan K. Lokhande, Dhanashree P. Sanap, Kisan R. Jadhav. Central Composite Design Augmented Quality-by-Design-Based Formulation of Ondansetron HCL Microemulsion Embedded Oral Thin Film. Research Journal of Pharmacy and Technology. 2025;18(9):4297-6. doi: 10.52711/0974-360X.2025.00617
Cite(Electronic):
Karan K. Lokhande, Dhanashree P. Sanap, Kisan R. Jadhav. Central Composite Design Augmented Quality-by-Design-Based Formulation of Ondansetron HCL Microemulsion Embedded Oral Thin Film. Research Journal of Pharmacy and Technology. 2025;18(9):4297-6. doi: 10.52711/0974-360X.2025.00617 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2025-18-9-37
9. REFERENCES:
1. Chowdary YA, Soumya M, Madhu BM, Aparna K, Himabindu P. A Review on Fast Dissolving Drug Delivery Systems- A Pioneering Drug Delivery Technology. Bulletin of Environment, Pharmacology and Life Sciences. 2012; 1(12): 8- 20.
2. Bhyan B, Jangra S, Kaur M, Singh H. Orally fast dissolving films: innovations in formulation and technology. International Journal of Pharmaceutical Sciences Review and Research. 2011; 9(2): 9-15. https://doi.org/10.4103%2F2230-973X.114897
3. Heinemann RJ, Carvalho RA, Favaro-Trindade CS. Orally disintegrating film (ODF) for delivery of probiotics in the oral cavity—development of a novel product for oral health. Innovative Food Science and Emerging Technologies. 2013; 1; 19: 227 232. https://doi.org/10.1016/j.ifset.2013.04.009
4. Sadique S, Ramya Sri S. Preparation and Evaluation of Fast Dissolving Oral Film of Losartan Potassium. Research Journal of Pharmaceutical Dosage Forms and Technology. 2020; 12(1): 13-16. https://doi.org/10.5958/0975-4377.2020.00003.8
5. Liang AC, Chen LL. Fast-dissolving intraoral drug delivery systems. Expert opinion on therapeutic patents. 2001; 11(6): 981-986. https://doi.org/10.1517/13543776.11.6.981
6. Yellanki SK, Jagtap S, Masareddy R. Dissofilm: a novel approach for delivery of phenobarbital; design and characterization. Journal of Young Pharmacists. 2011: 3(3): 181-188. https://doi.org/10.4103%2F0975-1483.83756
7. Arya A, Sharma V, Pathak K. Pharmaceutical evaluation and dynamic vapor sorption studies of fast dissolving intraoral films of Loratadine. Pharmaceutical Development and Technology. 2013; 18(6): 1329-1338. https://doi.org/10.3109/10837450.2012.685659.
8. Pezik E, Gulsun T, Sahin S, Vural I. Development and characterization of pullulan-based orally disintegrating films containing amlodipine besylate. European Journal of Pharmaceutical Sciences. 2021; 156: 105597. https://doi.org/10.1016/j.ejps.2020.105597.
9. Sakata Y, Otsuka M. Evaluation of relationship between molecular behaviour and mechanical strength of pullulan films. International Journal of Pharmaceutics. 2009; 374(1-2): 33-38. https://doi.org/10.1016/j.ijpharm.2009.02.019.
10. Mahesh A, Shastri N, Sadanandam M. Development of taste masked fast disintegrating films of levocetirizine dihydrochloride for oral use. Current drug delivery. 2010; 7(1): 21-27. https://doi.org/10.2174/156720110790396454.
11. Xu LL, Shi LL, Cao QR, Xu WJ, Cao Y, Zhu XY, Cui JH. Formulation and in vitro characterization of novel sildenafil citrate-loaded polyvinyl alcohol-polyethylene glycol graft copolymer-based orally dissolving films. International journal of pharmaceutics. 2014 473(1-2): 398-406. https://doi.org/10.1016/j.ijpharm.2014.07.037.
12. Kunte S, Tandale P. Fast dissolving strips: A novel approach for the delivery of verapamil. Journal of pharmacy and bioallied sciences. 2010; Oct 1; 2(4): 325-328. https://doi.org/10.4103%2F0975-7406.72133.
13. Pathare YS, Hastak VS, Bajaj AN. Polymers used for fast disintegrating oral films: a review. International Journal of Pharmaceutical Sciences Review and Research. 2013; 21(1): 169-178.
14. Von Schantz L, Schagerlof H, Nordberg Karlsson E, Ohlin M. Characterization of the substitution pattern of cellulose derivatives using carbohydrate-binding modules. BMC Biotechnology. 2014; 14: 1-8. https://doi.org/10.1186/s12896-014-0113-9
15. Khan MA, Ammen S, Zia A, Ijaz U, Jahanzaib HM, Sehar T, Sherazi BA, Hameed M, Tabassum N. Extraction, formulation and evaluation of fast dissolving oral films of nicotine for smoking cessation. Journal of Contemporary Pharmacy. 2018; 2(1): 1-6. https://doi.org/10.56770/jcp201801
16. Tipton LM, in: Skeel RT (Ed.), Handbook of Cancer Chemotherapy, Lippincott Williams and Wilkins, 2007 (Chapter 27).
17. Schwartberg LS, Oncology (Williston Park). 2007; 21(8): 946.
18. Al Abood RM, Talegaonkar S, Tariq M, Ahmad FJ. Microemulsion as a tool for the transdermal delivery of ondansetron for the treatment of chemotherapy induced nausea and vomiting. Colloids and Surfaces B: Biointerfaces. 2013; Jan 1; 101: 143-151. http://doi.org/10.1016/j.colsurfb.2012.06.015.
19. Currow DC, Coughlan M, Fardell B, Cooney NJ. Use of ondansetron in palliative medicine. Journal of pain and symptom management. 1997; 13(5): 302-307. https://doi.org/10.1016/s0885-3924(97)00079-1.
20. Jana SS, Lad MD, Subramanian S, Sanap DP. Ondansetron: A selective 5HT3 receptor antagonist and it advances in drug delivery system. World Journal of Advanced Research and Reviews. 2022; 16(3): 068-77. https://doi.org/10.30574/wjarr.2022.16.3.1275
21. Chokshi A, Vangara K, Chilampalli S, Narayanan E, Potta T. Development of sublingual spray formulation containing ondansetron hydrochloride dihydrate. Journal of Drug Delivery Science and Technology. 2019; 1; 53: 101160. https://doi.org/10.1016/j.jddst.2019.101160.
22. Sura L, Madhavan A, Carnaby G, Crary MA. Dysphagia in the elderly: management and nutritional considerations. Clinical interventions in aging. 2012; 30: 287-298. https://doi.org/10.2147/CIA.S23404.
23. Rodrigues RF, Costa IC, Almeida FB, Cruz RA, Ferreira AM, Vilhena JC, Florentino AC, Carvalho JC, Fernandes CP. Development and characterization of evening primrose (Oenothera biennis) oil nanoemulsions. Revista Brasileira de Farmacognosia. 2015; Jul 1; 25(4): 422-425. https://doi.org/10.1016/j.bjp.2015.07.014.
24. Sanap DP, Sapkal NP, Daud AS. Design and characterization of microemulsion system for fentanyl citrate. Research Journal of Pharmacy and Technology. 2023; 16(3): 1319-26. https://doi.org/10.52711/0974-360X.2023.00217
25. Mundhey DA, Sapkal NP, Daud AS. Optimization, characterization and in vitro evaluation of buprenorphine microemulsion. International journal of pharmaceutical sciences review and research. 2020; 25; 60: 67-75.
26. Bharti K, Mittal P, Mishra B. Formulation and characterization of fast dissolving oral films containing buspirone hydrochloride nanoparticles using design of experiment. Journal of Drug Delivery Science and Technology. 2019; 1; 49: 420-432. https://doi.org/10.1016/j.jddst.2018.12.013
27. Ouda GI, Dahmash EZ, Alyami H, Iyire A. A Novel Technique to Improve Drug Loading Capacity of Fast/Extended Release Orally Dissolving Films with Potential for Paediatric and Geriatric Drug Delivery. AAPS PharmSciTech. 2020; 7; 21(4): 1-14. https://doi.org/10.1208/s12249-020-01665-5
28. Subongkot T, Ngawhirunpat T. Development of a novel microemulsion for oral absorption enhancement of all-trans retinoic acid. International Journal of Nanomedicine. 2017; 3; 12: 5585-5599. https://doi.org/10.2147/IJN.S142503.
29. Zhang L, Yan Q, Zhang W, Li X, Zhang X, Du S, Hua X, Lin J, Shu G, Peng G, Tan Z. Enhancement of the functionality of attenuating acute lung injury by a microemulsion formulation with volatile oil of Angelicae Sinensis Radix and Ligusticum Chuanxiong Rhizoma encapsulated. Biomedicine and Pharmacotherapy. 2022; 156: 1-12. https://doi.org/10.1016/j.biopha.2022.113888.
30. Prajapati VD, Chaudhari AM, Gandhi AK, Maheriya P. Pullulan based oral thin film formulation of zolmitriptan: Development and optimization using factorial design. International Journal of biological macromolecules. 2018; 1; 107: 2075-2085. https://doi.org/10.1016/j.ijbiomac.2017.10.082.
31. Fathima F, Kumar BV, Rudrangi SR, Vemula SK, Garrepally P, Chilukula S, Rudrangi S. Formulation and evaluation of matrix-type transdermal delivery system of ondansetron hydrochloride using solvent casting technique. Research Journal of Pharmacy and Technology. 2011; 4(5): 806-814.
32. Srinivas A, Bhikshapathi DVRN. Fast Dissolving Oral Films of Pramipexole HCl Monohydrate: Preparation and In Vitro Evaluation. Research Journal of Pharmacy and Technology. 2018; 11(3): 1001–1008. https://doi.org/10.5958/0974-360X.2018.00187.7
33. Sharma D, Kaur D, Verma S, Singh D, Singh M, Singh G, Garg R. Fast dissolving oral films technology: A recent trend for an innovative oral drug delivery system. International Journal of Drug Delivery. 2015; 12; 7(2): 60-75.
34. Jayarao YR, Deborah D, Ambedkar T, Babu SM. Formulation and evaluation of fast dissolving oral films of perindopril. Research Journal of Pharmaceutical Dosage Forms and Technology. 2014; 6(2): 71-80.
35. Takeuchi Y, Ikeda N, Tahara K, Takeuchi H. Mechanical characteristics of orally disintegrating films: Comparison of folding endurance and tensile properties. International Journal of Pharmaceutics. 2020; 589: 119876. https://doi.org/10.1016/j.ijpharm.2020.119876.
36. Yin H, Jin W, Wang J, Ke J, Zhang W, Liu C, Wang W. Oral fast dissolving films for co-administration of breviscapine and matrine: Formulation optimization and in vitro characterization. Journal of Drug Delivery Science and Technology. 2024; 1; 95: 105548. https://doi.org/10.1016/j.jddst.2024.105548.
37. Singh A, Ansari VA, Haider F, Ahsan F, Mahmood T, Maheshwari S, Tiwari RK. Oral fast dissolving film: The avant-garde avenue for oral consignment modus operandi. Research Journal of Pharmacy and Technology. 2021; 14(4): 2145-2152. https://doi.org/10.52711/0974-360X.2021.00380
38. Zaki DY, Safwat EM, Nagi SM, Salem HN, Hamdy TM, Moharam LM, Hassan ML, Hamzawy EM. A novel dental re-mineralizing blend of hydroxyethyl-cellulose and cellulose nanofibers oral film loaded with nepheline apatite glass: preparation, characterization and in vitro evaluation of re-mineralizing effect. Carbohydrate Polymer Technologies and Applications. 2021; 25; 2: 100035. https://doi.org/10.1016/j.carpta.2021.100035.
39. Auda SH, El-Badry M, Ibrahim MA. Design, formulation and characterization of fast dissolving films containing dextromethorphan. Digest Journal of Nanomaterials and Biostructures (DJNB). 2014; 9(1): 133-141.
40. Shirole PL, Sanap DP, Jadhav KR. Development and Validation of a UV Spectrophotometric Method for determination of Ondansetron hydrochloride in Bulk and Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2024; 17(3): 1061-1064. https://doi.org/10.52711/0974-360X.2024.00165
41. Cheng T, Wang Z, Sun F, Liu H, Liu J, Guo Z, Zhou L. Gel properties of rice proteins-pectin composite and the delivery potential for curcumin: based on different concentrations and the degree of esterification of pectin. Food Hydrocolloids. 2024; Jan 1; 146: 109305. https://doi.org/10.1016/j.foodhyd.2023.109305.
42. Nawale RB, Deokate UA, Shahi SR, Lokhande PM. Formulation and Characterization of Efavirenz Nanosuspension by QbD approach. Research Journal of Pharmacy and Technology. 2017; 10(9): 2960–2972. http://dx.doi.org/10.5958/0974-360X.2017.00525.X
43. Bhagat BV, Darkunde SL. Orodispersible Film: A Novel Drug Delivery System. Research Journal of Pharmaceutical Dosage Forms and Technology. 2014; 7(10); 1196-1200.
44. Raja Y, Deborah D, Ambedkar T, Manohar Babu S. Formulation and Evaluation of Fast Dissolving Oral Films of Perindopril. Research Journal of Pharmaceutical Dosage Forms and Technology. 2014; 6(2):71-80
45. Nirmala D, Nandhini S, Sudhakar M. Design and evaluation of fast dissolving oral films of Zolpidem by solvent casting method. Asian Journal of Pharmaceutical Research. 2016; 6(2): 67-71. https://doi.org/10.5958/2231-5691.2016.00012.5
46. Sai KK. Formulation development and in vitro evaluation of memantine hydrochloride fast dissolving oral films employing different grades of hydroxy propyl methyl cellulose. Research Journal of Pharmacy and Technology. 2022; 15(1): 17-23. https://doi.org/10.52711/0974-360X.2022.00004
47. Sadique S, Ramya SS. Preparation and evaluation of fast dissolving oral film of Losartan Potassium. Research Journal of Pharmaceutical dosage forms and Technology. 2020; 12(1): 13-26. https://doi.org/10.5958/0975-4377.2020.00003.8
48. Sumedha B, Gopal G. Design and Optimization of Fast Dissolving Film of Losartan. Research Journal of Pharmaceutical Dosage Forms and Technology. 2014; 7(11): 1211-1218.
49. Suresh AM. Formulation and Evaluation of mucoadhesive buccal patches of Terbutaline Sulphate. Research Journal of Pharmaceutical Dosage Forms and Technology. 2016; 8(4): 248- 254.
50. Aldawsari HM, Badr-Eldin SM. Enhanced pharmacokinetic performance of dapoxetine hydrochloride via the formulation of instantly-dissolving buccal films with acidic pH modifier and hydrophilic cyclodextrin: Factorial analysis, in vitro and in vivo assessment. Journal of Advanced Research. 2020; Jul 1; 24: 281-290. https://doi.org/10.1016/j.jare.2020.04.019.
51. Mundhey D, Sapkal N, Daud A. Fabrication of microemulsion loaded sublingual film for rapid absorption of fentanyl citrate in transient breakthrough pain. International Journal of Applied Pharmaceutics. 2021; 13(3): 233-238.
52. Krull SM, Ma Z, Li M, Dave RN, Bilgili E. Preparation and characterization of fast dissolving pullulan films containing BCS class II drug nanoparticles for bioavailability enhancement. Drug Development and Industrial Pharmacy. 2016; 42(7): 1073-1085. https://doi.org/10.3109/03639045.2015.1107094.
53. Goudanavar PS, Bagali RS, Patil SM. Characterization and Evaluation of Glibenclamide Transmucosal Drug Delivery System. Research Journal of Pharmaceutical Dosage Forms and Technology. 2010; 2(1): 44-46.
54. Srikanth, Anand KY, Mallikarjuna SC. Formulation and Evaluation of Maltodextrin Based Doxorubicin HCl Proniosomes. Research Journal of Pharmaceutical Dosage Forms and Technology. 2019; Jun: 12(6); 2776-2780. https://doi.org/10.5958/0974-360X.2019.00466.9
55. Sanap DP, Mhatre US, Sheth RR. Oral Thin Films: A Multi – Faceted Drug Delivery System. International Journal of Pharmaceutical Sciences Review and Research. 2022; 72(1): 90-99. http://dx.doi.org/10.47583/ijpsrr.2022.v72i01.013.
56. Mundhey D, Sapkal N, Daud A. Fabrication of an abuse deterrent and microemulsion-based sublingual film of buprenorphine hydrochloride for breakthrough pain management. International Journal of Applied Pharmaceutics. 2020; 12(6): 127-135.
57. Deshmane SV, Chinchole PP, Gaurkhede RM, Channawar MA, Chandewar AV. The Biopharmaceutics Classification System: A Review. Research Journal of Pharmaceutical Dosage Forms and Technology. 2009; 2(1); 8-11.