Volume : 13, Issue : 06, June – 2026
Title:
FORMULATION DEVELOPMENT AND EVALUATION OF FAST DISSOLVING ORAL THIN FILM OF ANTIDIABETIC DRUG GLIMEPIRIDE FOR ORAL DRUG DELIVERY
Authors :
Mamta D. Chavan*, Dr. Ravi Uttamrao Kurhade, Mr. Nishinandan Manikrao Shinde
Abstract :
The present study focuses on the formulation and evaluation of mouth dissolving oral films of Glimepiride with the aim of enhancing its dissolution rate, bioavailability, and patient compliance. Glimepiride, a BCS Class II drug, exhibits poor aqueous solubility, which limits its therapeutic effectiveness when administered through conventional dosage forms. Preformulation studies, including organoleptic evaluation, solubility analysis, melting point determination, and FTIR spectroscopy, confirmed the purity, identity, and compatibility of the drug with selected excipients such as HPMC, PVA, and PEG 400. Mouth dissolving films were prepared using the solvent casting method by varying the concentrations of polymers and plasticizer. A total of nine formulations (F1–F9) were developed and evaluated for physicochemical and performance parameters including weight variation, folding endurance, disintegration time, surface pH, drug content, and in vitro drug release. All formulations exhibited satisfactory characteristics with good uniformity and mechanical strength. Among the prepared batches, formulation F7 was identified as the optimized formulation, demonstrating excellent properties such as rapid disintegration (24 ± 1.80 sec), high folding endurance (232 ± 6), near-neutral surface pH (6.91 ± 0.04), uniform drug content (99.82 ± 0.60%), and complete drug release (100% within 10 minutes). Stability studies conducted under accelerated conditions revealed that the optimized formulation remained stable over a period of three months, with no significant changes in its physicochemical properties or drug release profile. In conclusion, the developed mouth dissolving oral film of Glimepiride represents a promising drug delivery system for improving dissolution rate, bioavailability, and patient compliance, particularly in geriatric and pediatric populations.
KEYWORDS: Glimepiride, Mouth dissolving film, Solvent casting method, Fast dissolving oral film, BCS Class II drug, In vitro dissolution, Drug release , Polymer (HPMC, PVA) , PEG 400, Stability study etc.
Cite This Article:
Please cite this article in press Mamta D. Chavan et al., Formulation Development And Evaluation Of Fast Dissolving Oral Thin Film Of Antidiabetic Drug Glimepiride For Oral Drug Delivery.., Indo Am. J. P. Sci, 2026; 13(06).
REFERENCES:
1. Irfan M, Rabel S, Bukhtar Q, Qadir MI, Jabeen F, Khan A. Oral fast dissolving films: a modern expansion in drug delivery system. Saudi Pharm J. 2016;24(5):537–546.
2. Haque S, et al. Development and evaluation of fast dissolving films of metformin using chitosan. Int J Pharm Pharm Sci. 2015;7(4):234–239.
3. Boateng JS, Stevens HNE, Eccleston GM, Auffret AD, Humphrey MJ, Matthews KH. Development and mechanical characterization of solvent-cast polymeric films. Drug Dev Ind Pharm. 2009;35(8):986–996.
4. Jelvehgari M, et al. Preparation and evaluation of fast dissolving oral thin films of ergotamine tartrate and caffeine. Adv Pharm Bull. 2015;5(2).
5. Kumar S, et al. Development of oral fast dissolving films of salbutamol sulphate. Int J Pharm Sci Nanotechnol. 2014;7(2):2450–2457.
6. Gill B, et al. Enhancement of solubility and dissolution of glimepiride using solid dispersion technique with poloxamer 188. J Pharm Sci Res. 2014;6(9).
7. Siddiqui N, Garg G, Sharma PK. Fast dissolving films: preparation, characterization and applications. Drug Deliv. 2011;18(7).
8. Garsuch V, Breitkreutz J. Comparative investigations on different polymers for preparation of fast dissolving oral films. Drug Dev Ind Pharm. 2010;36(3).
9. Müller G, Wied S, Crecelius A, Köhnke R, Eckel J. Glimepiride: evidence for dual mechanisms of action. Diabetes Res Clin Pract. 1998;40(Suppl):S147–S153.
10. Proks P, Reimann F, Green N, Gribble F, Ashcroft F. Sulfonylurea stimulation of insulin secretion. Diabetes. 2002;51(Suppl 3):S368–S376.
11. Davis SN. The role of glimepiride in the effective management of Type 2 diabetes. J Diabetes Complications. 2004;18(6):367–376.
12. Drug Bank. Glimepiride: pharmacological profile and properties. DrugBank Database. 2023.
13. United States Pharmacopeia (USP 43–NF 38). Rockville, MD: United States Pharmacopeial Convention; 2020.
14. Sweetman SC, editor. Martindale: The Complete Drug Reference. 38th ed. London: Pharmaceutical Press; 2014.
15. Rowe RC, Sheskey PJ, Quinn ME, editors. Handbook of Pharmaceutical Excipients. 6th ed. London: Pharmaceutical Press; 2009.
16. Nokhodchi A, Ford JL, Rubinstein MH. Studies on the interaction between HPMC and drugs. Int J Pharm. 1997;157(1):61–73.
17. Siepmann J, Peppas NA. Modeling of drug release from delivery systems based on HPMC. Adv Drug Deliv Rev. 2012;64:163–174.
18. Hassan CM, Peppas NA. Structure and applications of polyvinyl alcohol hydrogels. Adv Polym Sci. 2000;153:37–65.
19. Boateng JS, Auffret AD, Matthews KH, Humphrey MJ, Stevens HN, Eccleston GM. Characterisation of freeze-dried wafers and films. Eur J Pharm Biopharm. 2010;76(2):268–276.
20. Rowe RC, Sheskey PJ, Quinn ME. Handbook of Pharmaceutical Excipients. London: Pharmaceutical Press; 2009.
21. Strickley RG. Solubilizing excipients in oral and injectable formulations. Pharm Res. 2004;21(2):201–230.
22. Desai PM, Liew CV, Heng PW. Review of disintegrants and superdisintegrants. Int J Pharm. 2016;510(2):395–406.
23. Mohanachandran PS, Sindhumol PG, Kiran TS. Superdisintegrants: an overview. Int J Pharm Sci Rev Res. 2011;6(1):105–109.
24. Shangraw RF, Mitrevej A, Shah M. A new era of tablet disintegrants. Pharm Technol. 1980;4:49–57.
25. Zhao N, Augsburger LL. Functionality comparison of crospovidone. AAPS PharmSciTech. 2005;6(4):E634–E640.
26. Magnuson BA, Burdock GA, Doull J, et al. Aspartame: safety evaluation. Crit Rev Toxicol. 2007;37(8):629–727.
27. Butchko HH, Stargel WW. Aspartame: scientific evaluation in food. Regul Toxicol Pharmacol. 2001;34(3):221–233.
28. Socrates G. Infrared and Raman Characteristic Group Frequencies. 3rd ed. Wiley; 2001.
29. Rowe RC, Sheskey PJ, Quinn ME. Handbook of Pharmaceutical Excipients. London: Pharmaceutical Press; 2009.
30. Indian Pharmacopoeia Commission. Indian Pharmacopoeia. Vol. II. Ghaziabad: IPC; 2018.
31. United States Pharmacopeial Convention. United States Pharmacopeia 43–National Formulary 38. Rockville, MD: USP; 2020.
32. ICH. Q2(R1): Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation; 2005.
33. Banker GS, Rhodes CT. Modern Pharmaceutics. 4th ed. New York: Marcel Dekker; 2002.
34. Aulton ME, Taylor K. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines. 5th ed. London: Elsevier; 2018.
35. Lachman L, Lieberman HA, Kanig JL. The Theory and Practice of Industrial Pharmacy. 3rd ed. Mumbai: Varghese Publishing House; 2009.
36. Allen LV. Pharmaceutical Dosage Forms and Drug Delivery Systems. 10th ed. Philadelphia: Lippincott Williams & Wilkins; 2014.
37. Rasve V, Chakraborty AK, Jain SK, Vengurlekar S. Comparative evaluation of antidiabetic activity of ethanolic leaves extract of Clematis triloba and their SMEDDS formulation in streptozotocin-induced diabetic rats. J Popul Ther Clin Pharmacol. 2022;29(4):959-971. doi:10.53555/jptcp.v29i04.2360.
38. Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: An innovative drug delivery system. Int J ChemTech Res. 2010;2(1):576–83.
39. Bhyan B, Jangra S, Kaur M, Singh H. Orally fast dissolving films: Innovations in formulation and technology. Int J Pharm Sci Rev Res. 2011;9(2):50–7.
40. Cilurzo F, Cupone IE, Minghetti P, Selmin F, Montanari L. Fast dissolving films made of maltodextrins. Eur J Pharm Biopharm. 2008;70(3):895–900.
41. Preis M, Knop K, Breitkreutz J. Mechanical strength test for orodispersible and buccal films. Int J Pharm. 2014;461(1–2):22–9.
42. Garsuch V, Breitkreutz J. Novel analytical method for the characterization of oral wafers. Eur J Pharm Biopharm. 2010;73(1):195–201.
43. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. US FDA; 1997.
44. Patel VF, Liu F, Brown MB. Advances in oral transmucosal drug delivery. J Control Release. 2011;153(2):106–16.
45. Boateng JS, Auffret AD, Matthews KH, Humphrey MJ, Stevens HNE, Eccleston GM. Characterisation of freeze-dried wafers. Eur J Pharm Biopharm. 2010;76(2):296–303.
46. Kulkarni AS, Deokule HA, Mane MS, Ghadge DM. Exploration of different polymers for use in the formulation of oral fast dissolving strips. J Curr Pharm Res. 2010;2(1):33–5.
47. Siddiqui MN, Garg G, Sharma PK. A short review on “A novel approach in oral fast dissolving drug delivery system and their patents”. Adv Biol Res. 2011;5(6):291–303.