Author(s):
C. Rubina Reichel, Santhiya L, Sarah Alexandrina J, Sathiya Raj R, Sethuraman A, Shibiyaa S
Email(s):
rubinareichel@gmail.com
DOI:
10.52711/0974-360X.2025.00154 
Address:
C. Rubina Reichel, Santhiya L, Sarah Alexandrina J, Sathiya Raj R, Sethuraman A, Shibiyaa S
Department of Pharmaceutics, College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences (Affiliated to The Tamilnadu Dr. M.G.R. Medical University), Coimbatore - 44.
*Corresponding Author
Published In:
Volume - 18,
Issue - 3,
Year - 2025
ABSTRACT:
The objective of the present study was to develop the oral fast-dissolving film of empagliflozin by using solvent Solvent-casting method. Empagliflozin is a Class III drug used for the management of type 2 diabetes mellitus. Fast-dissolving oral films of empagliflozin were prepared with different excipients and were evaluated with various evaluation parameters. FTIR analysis showed that there was no chemical reaction between the drug and the excipients. HPMC is used as a polymer, PEG acts as a plasticizer and solubility enhancer, sodium starch glycolate acts as a super disintegrant, and DMSO is mainly used as a permeability enhancer. Evaluation of oral films includes such as Weight variation, Thickness, Folding endurance, % Elongation, Tensile strength, Drug content, Assay, Disintegration time, and invitro Diffusion studies were done. The results showed the most promising results. In this formulation 4 showed good disintegration at 20 minutes and 99% drug release within 30 minutes. The stability study results showed the prepared films were stable during the stability study.
Cite this article:
C. Rubina Reichel, Santhiya L, Sarah Alexandrina J, Sathiya Raj R, Sethuraman A, Shibiyaa S. Formulation and Evaluation of Fast-Dissolving Oral Films of Empagliflozin. Research Journal Pharmacy and Technology. 2025;18(3):1072-7. doi: 10.52711/0974-360X.2025.00154
Cite(Electronic):
C. Rubina Reichel, Santhiya L, Sarah Alexandrina J, Sathiya Raj R, Sethuraman A, Shibiyaa S. Formulation and Evaluation of Fast-Dissolving Oral Films of Empagliflozin. Research Journal Pharmacy and Technology. 2025;18(3):1072-7. doi: 10.52711/0974-360X.2025.00154 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-3-15
REFERENCES:
1. Suresh B, Halloran D, James L. Quick dissolving films. A novel approach to drug delivery. Drug. Dev. Tech. 2006; 1-7. http://www.drugdeliverytech.com
2. Chan SY, Chen LL, Chetty D, Inventors. Orally Dissolving Films. US Patent 20060198873A1. 2006 Sep 7.
3. Biradar SS. Bhagvati ST, Kuppasad IJ. Fast dissolving drug delivery systems; a brief review. Internet J Pharmcol. 2006; 4(2).
4. Cilurzo F, Minghetti P, Como A, Montanari L. Feasibility study of fast-dissolving film containing Piroxicam.The AAPS Journal. 2005; 7: S2 W4148-W4148. AAPS Annual Meeting and Exposition, Nashville, 2005
5. Fulzele S V, Satturwar P M, Dorle A K. Polymerised rosin. Novel Film Forming Polymer for drug delivery. Int J Pharm. 2002; 249: 175-184. Doi: 10.1016/S0378-5173(02)00529-X
6. Gohel MC, Sharma R, Soniwala MM. Development of taste-masked film of Valdecoxib for oral use. Ind J Pharm Sci. 2007; 69: 318-320.
7. Aditya Dinge. Formulation and evaluation of fast-dissolving films for delivery of triclosan to the oral cavity. American Association of Pharmaceutical Scientists Technology. 2008; 9: 349-356.
8. Parul Saini, Anoop Kumar, Pankaj Sharma, Sharad Visht. Fast Disintegrating Oral Films: A Recent Trend of Drug Delivery International Journal of Drug Development and Research, 2012; 4(4): 80-94.
9. Pallavi Patil. S. K. Shrivastava. Fast Dissolving Oral Films. An Innovative Drug Delivery System. International Journal of Science and Research. 2014; 3(7).
10. Renuka Mishra, Avani Amin. Formulation and Characterization of Rapidly Dissolving Films of Cetirizine Hydrochloride Using Pullulan as a Film Forming Agent. Indian Journal of Pharmaceutical Education and Research. 2011; 45: 71-77.
11. Mohammed Gulzar Ahmed. Formulation of chitosan-based ciprofloxacin and diclofenac film for periodontitis therapy. Tropical Journal of Pharmaceutical Research. 2009; 33-41.
12. Yoshinori Itoh. Preparation of a fast-dissolving oral thin film containing dexamethasone: A possible application to antiemesis during cancer chemotherapy. European Journal of Pharmaceutics and Biopharmaceutics. 2009: 361–365.
13. Sandeep Saini. Formulation and Evaluation of Oral Fast Dissolving Anti-Allergic Film of Levocetrizine Dihydrochloride. Journal of Pharmaceutical Science and Research. 2011; 3: 1322-1325.
14. Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010; 87(1): 4-14.
15. International journal of inventions in pharmaceutical Sciences polyol pathway: Anusha Chauhan H, Geetha H, Vijay R Chidrawar, Uma Maheswara Rao v, a review on a potential target for the prevention of diabetic complications, Int.J.Inv.Pharm.Sci., 2014; 2(2): 696-711
16. Macha S, Mattheus M, Pinnetti S, Seman L, Woerle HJ. Pharmacokinetics of empagliflozin, a sodium-glucose cotransporter 2 inhibitor and glimepiride following coadministration in healthy volunteers: a randomized, open-label, crossover study. J Diabetes Res Clin Metab. 2012; 29: 889-99.
17. Anas M Hanif et al,Optimization of empagliflozin immediate-release tablets using central composite rotatable design with response surface methodology. Pak J Pharm Sci. 2021; 34(4(Supplementary)):1519-1525
18. Akanksha dwivediand G. N. Darwhekar .Design, Optimization and evaluation of empagliflozin orodispersible tablets using different super disintegrants. Int J Pharm Pharm Sci. 2019; 11(7): 32-41, DOI: http://dx.doi.org/10.22159/ijpps.2019v11i7.33213
19. S. Raju. et al. Flash release oral films of metoclopramide hydrochloride for pediatric use: Formulation and in-vitro evaluation. Journal of Chemical and Pharmaceutical Research, 2011
20. Mashru R.C, Sutariya BC, Parikh PP. Development and evaluation of fast-dissolving films of salbutamol sulphate. Drug Dev Ind Pharm. 2005; 31: 25-34.Doi: 10.1081/DDC-200043947
21. Deepti Piya Baniya, Gaurav Pandey, Mijala Bajaracharya, Bishwo Raj Dhungana. Formulation and Evaluation of Fast Dissolving Oral Films of Cetirizine Hydrochloride. Europasian Journal of Medical Sciences. 2020; 2(1): 23-29 https://doi.org/10.4640526/ejms.v2i1.19
22. Ali MS, Vijendar C, Kumar SD, Krishnaveni J. Formulation and Evaluation of Fast Dissolving Oral Films of Diazepam. J Pharmacovigilance. 2016; 4(3): 1000210. doi:10.4172/2329-6887.100021