Formulation And In-Vitro Evaluation Of Gliclazide Oro-Dispersible Tablets
Keywords:
Gliclazide, Diabetes mellitus, oro-dispersible tablets, superdisintegrants, in-vitro releaseAbstract
Introduction:
Gliclazide is a second-generation sulfonylurea used for the management of type II diabetes mellitus. Due to its poor water solubility, the onset of action may be delayed. The primary objective of the present study was to formulate Gliclazide oro-dispersible tablets (ODTs) to enhance solubility and dissolution rate, thereby promoting a faster onset of therapeutic action.
Methods:
Gliclazide ODTs were formulated using the direct compression method with three different superdisintegrants: Crospovidone, Sodium Starch Glycolate (SSG), and Croscarmellose sodium. A total of nine formulations were developed. Differential Scanning Calorimetry (DSC) was performed to evaluate potential drug–excipient interactions. All formulations were assessed for physicochemical properties, in vitro drug release, and release kinetics. The optimized formulation was further subjected to a 6-month stability study under ICH-recommended conditions.
Results:
All formulations complied with pharmacopeia specifications. Among them, formulation F3 exhibited the fastest disintegration time (19.1 seconds) and achieved 99.31% drug release within 15 minutes, attributed to the efficient wicking and swelling properties of crospovidone. Based on disintegration time and drug release performance, F3 was identified as the optimized formulation. It remained physically and chemically stable over a 6-month period.
Conclusion:
Gliclazide ODTs were successfully developed using direct compression and superdisintegrants such as Crospovidone, SSG, and Croscarmellose Sodium. The optimized formulation (F3) demonstrated rapid disintegration, enhanced drug release, and stability over 6 months, indicating its potential for improved patient compliance and faster therapeutic onset in the treatment of type II diabetes
Downloads
Metrics
References
Chein YW. Oral drug delivery and delivery system. New York: Marcel Dekker; 1992.
Bandari S, Mittapalli RK, Gannu R, Rao YM. Orodispersible tablets: An overview. Asian Journal of Pharmaceutics. 2008; 2(1): 2–11.
Kamble SK, Shinde SS. Design and Development of Fast Dissolving Tablet of Gliclazide. Journal of Developing Drugs. 2017; 6: 177.
Debnath D, Ashutosh KS, Dharmaraju M. Formulation, development and in vitro release kinetics of gliclazide tablet using different super disintegrating agents. CIBTech Journal of Pharmaceutical Sciences. 2015; 4: 12–25.
Gupta D, Maurya A, Varshney M. Orodispersible Tablets: An Overview of Formulation and Technology. World Journal of Pharmacy and Pharmaceutical Sciences. 2020; 9(10): 1406–18.
Venkatarao R, Vinod Kumar K, Thangabalan B. Development and characterization of Gliclazide oral disintegrating tablets. International Journal of Allied Medical Sciences Clinical Research. 2024; 12(1): 4–12.
Meghana P, Mrinalini D. Development and validation of dissolution method for Gliclazide tablets. Asian Journal of Pharmaceutics and Clinical Research. 2022; 15(8): 170-174.
Shafiqul Islam Sovon, Habibullah, Hafizur Rahman, Tushar Saha. In vitro characteristics comparison of prepared immediate release tablet of gliclazide with innovator drug and selected market samples of Bangladesh. Journal of Complementary Medicine & Alternative Healthcare. 2018; 8(4): 14–122.
Ghourichay M, Kiaie S, Nokhodchi A, Javadzadeh Y. Formulation and quality control of orally disintegrating tablets (ODTs): recent advances and perspectives. BioMed Research International. 2021; 2021: 661-668.
Agarwal S, Misra R, Gautam G. Formulation, development and in vitro evaluation of taste masking mouth dissolving tablets of levocetrizine dihydrochloride. International Journal of Pharma Professional’s Research. 2023; 14(1): 47-58.
Lin Z, Xuan J. Cost-effectiveness of aripiprazole orally disintegrating tablets in the treatment of schizophrenia in China. Expert Review Pharmacoeconomics & Outcomes Research. 2020; 20(5): 549-557.
Tapre D, Borikar S, Jain S, Walde S, Tapadiya G, Gurumukhi V. Development and evaluation of novel famotidine-loaded fast dissolving sublingual film using the quality-by-design approach. Journal of Drug Delivery Science and Technology. 2023; 85.
Dhiman J, Dev D, Prasad D. Superdisintegrants: Brief review. Journal of Drug Delivery and Therapeutics. 2022; 12(1):170-175..
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
Terms:
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
