DEVELOPMENT AND IN VITRO ANTIDIABETIC ASSESSMENT OF SUSTAINED RELEASE VILDAGLIPTIN TABLETS USING NATURAL POLYMERS THROUGH DIPEPTIDYL PEPTIDASE-4 INHIBITION
DOI:
https://doi.org/10.22159/ajpcr.2026v19i2.57419Keywords:
Vildagliptin, Sustained-release tablets, Mimosa mucilage, Tinospora mucilage, Dipeptidyl peptidase-4 enzyme inhibition, Antidiabetic activityAbstract
Objectives: The objective of the study is to develop sustained-release (SR) vildagliptin tablets using natural mucilages from Mimosa pudica and Tinospora cordifolia and to evaluate their physicochemical properties, release kinetics, and in vitro antidiabetic activity.
Methods: Mucilages were characterized and used as release modifiers in SR tablets. Pre- and post-compression parameters were assessed per pharmacopeial standards. In vitro drug release was measured for 12 h (n=6) and fitted to kinetic models. Dipeptidyl peptidase-4 inhibition and half maximal inhibitory concentration (IC50) values were determined for pure drug and the optimized formulation.
Results: The mucilages exhibited good flow (angle of repose 27–35°; Carr’s index 13–19%). All batches met pharmacopeial limits (hardness 5.0–5.6 kg/cm2; friability <1%). Formulation F3 showed controlled release with 98.5–99.0% drug release at 12 h, following zero-order (R2=X) and Korsmeyer–Peppas kinetics (n=Y). F3 retained antidiabetic activity with % inhibition of Z% at Q μg/mL, and an IC50 of Y μg/mL, compared to X μg/mL for pure vildagliptin.
Conclusion: Mimosa and Tinospora mucilages are promising low-cost, biodegradable alternatives to synthetic polymers for SR vildagliptin tablets. Further in vivo studies are recommended to confirm therapeutic benefits.
Downloads
References
1. Dey RK. Diabetes mellitus: A comprehensive review of pathophysiology, management, and emerging therapeutic approaches. J Diabetes Med Care. 2023;6(4):96-100. doi: 10.37532/jdmc.2023.6(4).96-100
2. Srivastava A, Khan MA, Bedi S, Bhandari U. Design, optimization, and characterization of a novel amorphous solid dispersion formulation for enhancement of solubility and dissolution of ticagrelor. Int J Appl Pharm. 2023;15(4):296-305. doi: 10.22159/ijap.2023v15i4.47618
3. Nawale RB, Sahu SK, Vyas M. Improved bioavailability of atorvastatin and fenofibrate through ternary solid dispersions: A polymer-supported method for the ultimate solubility enhancement. Int J Appl Pharm. 2025;17(6):255-66. doi: 10.22159/ijap.2025v17i6.54838
4. Kinkar R, Kumar P, Jain P. Formulation and evaluation of quercetin ultra-flexible nanocarrier for ocular delivery system in macular edema management. Int J Adv Pharm. 2024;14(2):43-51.
5. Antar SA, Ashour NA, Sharaky M, Khattab M, Ashour NA, Zaid RT, et al. Diabetes mellitus: Classification, mediators, and complications; a gate to identify potential targets for the development of new effective treatments. Biomed Pharmacother. 2023;168:115734. doi: 10.1016/j. biopha.2023.115734, PMID 37857245
6. Bhowmik D, Chiranjib CM, Chandira MG, Jayakar B, Sampath KP. Natural polymers: An overview. J Pharm Innov J. 2014;3(10):112-7.
7. Bukhari SN, Ali A, Hussain MA, Tayyab M, Alotaibi NF, Elsherif MA, et al. Extraction optimization of mucilage from seeds of Mimosa pudica by response surface methodology. Polymers (Basel). 2022;14(9):1904. doi: 10.3390/polym14091904, PMID 35567073
8. Taru P, Walunj D, Sayd S, Saindane R. Gums and mucilages: Versatile natural polymers. In: Jailani S, Vinchurkar K, Suryawanshi M, Mane S, editors. Innovative Pharmaceutical Excipients: Natural Sources. Singapore: Springer; 2025. p. 209-27. doi: 10.1007/978-981-96-7959-1_9
9. Jani GK, Shah DP, Prajapati VD. Gums and mucilages: Versatile excipients for pharmaceutical formulations. Asian J Pharm Sci. 2021;16(2):139-53.
10. Sarkar P, Majee SB. Formulation development and in vitro characterization of ternary hydrotropic solid dispersions of aceclofenac. Asian J Pharm Clin Res. 2022 Sep;15(9):174-9. doi: 10.22159/ ajpcr.2022.v15i9.45158
11. Mahapatra SK, Verma S. Formulation and evaluation of polyherbal tablet for better therapeutic efficacy. Res J Pharm Technol. 2023;16(2):835-8. doi: 10.52711/0974-360X.2023.00142
12. Jha SK, Devanna CV, Parameshwar K, Reddy MR. Formulation development and evaluation of vildagliptin sustained release tablet. Int J Drug Deliv Technol. 2018;8(4):180-6. doi: 10.25258/ijddt.8.4.5.
13. Saravanan C, Bharani R, Barathraj V, Balaji K, Balaji R, Balaji R. Formulation and evaluation of sustained release dosage form using xanthangumas naturalpolymer -an updatedreview. Int J Adv Pharm. 2025;15(1):1-8.
14. Farooqui P, Gude R. Formulation development and optimisation of fast dissolving buccal films loaded glimepiride solid dispersion with enhanced dissolution profile using central composite design. Int J Pharm Pharm Sci. 2023 Jun;15(6):35-54. doi: 10.22159/ ijpps.2023v15i6.47992
15. Pandey R, Khuller GK. Plant-based excipients for controlled release formulations. Phytother Res. 2020;34(9):2215-24.
16. Patra CN, Behera S, Majumdar S, Nayak S, Dash S. Natural polymers in drug delivery. Trop J Pharm Res. 2016;15(2):255-64.
17. Leel M, Singh P, Sharma M, Verma M. A review: Oral dispersible tablets. Int J Curr Pharm Rev Res. 2022;13(4):25-34.
18. Mohan S. Compression physics of pharmaceutical powders: A review. Int J Pharm Sci Res. 2012;3(6):1580-92.
19. Palei NN, Mamidi SK, Rajangam J. Formulation and evaluation of lamivudine sustained release tablet using okra mucilage. J App Pharm Sci. 2016;6(9):69-75. doi: 10.7324/japs.2016.60910
20. Suhel T, Jain V, Khangar PK, Jain RK. Formulation and evaluation of metformin hydrochloride sustained release tablet. Int J Med Sci Pharm Res. 2022;8(3):28-32. doi: 10.22270/ijmspr.v8i3.5621. Anil BS, Ashok DG, Muley SS, Kolhe SD. A review: Formulation and evaluation of sustained release tablet. Quest J Res PharmSci. 2024;10(4):74-9.
22. Rajaei E, Jalali MT, Shahrabi S, Asnafi AA, Pezeshki SM. HLAs in autoimmune diseases: Dependable diagnostic biomarkers? Curr Rheumatol Rev. 2019;15(4):269-76. doi: 10.2174/1573397115666190 115143226, PMID 30644346
23. Rathi PC, Biyani KR. Formulation and evaluation of natural polymer-based sustained release matrix tablets containing salbutamol sulphate. Int J Pharm Sci Rev Res. 2024;84(4):50-5. doi: 10.47583/ijpsrr.2024. v84i04.006
24. Kulkarni GT, Gowthamarajan K, Rao GB. Evaluation of natural polymers as drug release retardants. Indian Drugs. 2011;48(12):37-44.
25. Rani S, Kumar P, Sahu S. Natural polymers for sustained-release drug delivery systems. J Appl Pharm Sci. 2017;7(6):245-52.
26. Satchanska G, Davidova S, Petrov PD. Natural and synthetic polymers for biomedical and environmental applications. Polymers (Basel). 2024;16(8):1159. doi: 10.3390/polym16081159, PMID 38675078
27. Shah RS, Shah RR, Nitalikar MM, Magdum CS. Design, development and evaluation of enteric coated tablets of glimepiride. Asian Jour Pharmac Rese. 2017;7(3):155. doi: 10.5958/2231-5691.2017.00024.7.
28. Chaturvedi H, Garg A, Rathore US. Post-compression evaluation parameters for tablets-an overview. Eur J Pharm Med Res. 2017;4(11):526-30.
29. Singh S. Saini TR. HPMC and natural polymer combinations for sustained release. Indian J Pharm Educ Res. 2019;53(3):395-400.
30. Veerapandian M, Ramasundaram S, Jerome P, Chellasamy G, Govindaraju S, Yun K, et al. Drug delivery application of functional nanomaterials synthesized using natural sources. J Funct Biomater. 2023;14(8):426. doi: 10.3390/jfb14080426, PMID 37623670
31. Yamasaki S, Kadowaki M, Jiromaru T, Takase K, Iwasaki H. Acquired hemophilia A associated with dipeptidyl peptidase-4 inhibitors for the treatment of type 2 diabetes mellitus: A single-center case series in Japan. Diabetes Ther. 2019;10(3):1139-43. doi: 10.1007/s13300-019- 0609-3, PMID 30927215
32. Ghumman SA, Mahmood A, Noreen S, Hameed H, Kausar R, Rana M, et al. Mimosa pudica mucilage nanoparticles of losartan potassium: Characterization and pharmacodynamics evaluation. Saudi Pharm J. 2023;31(8):101695. doi: 10.1016/j.jsps.2023.101695, PMID 37520120
33. Qureshi MI, Khan N, Raza H, Imran A, Ismail F. Digital technologies in education 4.0. Does it enhance the effectiveness of learning? A systematic literature review. Int J Interact Mob Technol. 2021;15(4): 31-47. doi: 10.3991/ijim.v15i04.20291
Published
How to Cite
Issue
Section
Copyright (c) 2026 Poonam Taru, T. Shanmugarajan, E. Bhavya
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.