Formulation Development and Evaluation of Sitagliptin Phosphate Monohydrate and Metformin HCl Tablets
Bharathi Arigela*, Kovida Chanumolu, Yamini Durga Talaparthi, Dasari Naga Rama Keerthana, Kambhagalla Sukhi
Department of Pharmaceutics and Biotechnology, KVSR Siddhartha College of Pharmaceutical Sciences, Vijayawada, Andhra Pradesh, India
Received: 11th Jun, 2025; Revised: 6th Aug, 2025; Accepted: 20th Aug, 2025; Available Online: 25th Sep, 2025
ABSTRACT
Insulin resistance is actively treated with metformin. This drug improves insulin sensitivity and is essential for managing type 2 diabetes. Glucose can treat diabetes alone if there are no safety concerns, such as renal or liver disease, gastrointestinal difficulties, or lactic acidosis. Metformin is safe and effective. Metformin is the only oral diabetes medicine that does not cause weight gain. Additionally, many diabetics only take this medicine. Treatment for type 2 diabetes usually begins with metformin and sitagliptin. This helps manage blood sugar when diet and exercise fail. When administered alone, sitagliptin plus metformin may not regulate blood glucose well. This aims to manufacture film-coated metformin phosphate monohydrate and hydrochloride tablets in various dosages. This study seeks to create a fixed dose pharmaceutical combination for non-insulin-dependent diabetic mellitus. Metformin HCl with Sitagliptin may improve blood sugar management and HbA1c levels. This combination causes minimal weight gain and fewer adverse effects. This study created and tested sitagliptin-metformin HCl film coated tablets. Wet granulation was used to make the tablets with the requisite excipients. The tablet's parameters before and after compression were evaluated according to the standard. The pre-compression factors, including overall and tapped density, showed good flow characteristics. The weight, hardness, thickness, friability, disintegration, drug concentration, and drug release % were assessed after compression. Results showed these parameters were within acceptable ranges.
Keywords: Insulin resistance, type 2 diabetes, Metformin HCl, Sitagliptin, film coated tablets.
How to cite this article: Bharathi Arigela, Kovida Chanumolu, Yamini Durga Talaparthi, Dasari Naga Rama Keerthana, Kambhagalla Sukhi. Formulation Development and Evaluation of Sitagliptin Phosphate Monohydrate and Metformin HCL Tablets. International Journal of Drug Delivery Technology. 2025;15(3):952-58. doi: 10.25258/ijddt.15.3.7
REFERENCES
- Tomkins M, Lawless S, Martin-Grace J, Sherlock M, Thompson CJ. Diagnosis and Management of Central Diabetes Insipidus in Adults. J Clin Endocrinol Metab. 2022 Sep 28;107(10):2701-2715. doi: 10.1210/clinem/dgac381. PMID: 35771962; PMCID: PMC9516129.
- Christ-Crain M, Winzeler B, Refardt J. Diagnosis and management of diabetes insipidus for the internist: an update. J Intern Med. 2021 Jul;290(1):73-87. doi: 10.1111/joim.13261. Epub 2021 Mar 13. PMID: 33713498.
- Redondo MJ, Morgan NG. Heterogeneity and endotypes in type 1 diabetes mellitus. Nat Rev Endocrinol. 2023 Sep;19(9):542-554. doi: 10.1038/s41574-023-00853-0. Epub 2023 Jun 19. PMID: 37337007.
- Han R, Zhang Y, Jiang X. Relationship between four non-insulin-based indexes of insulin resistance and serum uric acid in patients with type 2 diabetes: a cross-sectional study. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy. 2022 Jan 1:1461-71.
- Choudhury AA, Rajeswari VD. Gestational diabetes mellitus-A metabolic and reproductive disorder. Biomedicine & Pharmacotherapy. 2021 Nov 1;143:112183.
- Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes research and clinical practice. 2010 Jan 1;87(1):4-14.
- Mohajan D, Mohajan HK. Metformin: an oral anti-hyperglycaemic agent for the treatment of type 2 diabetes. Journal of Innovations in Medical Research. 2023 Nov 9;2(11):1-8.
- Aware M, Gondkar S, Bachhav R. Formulation And In vitro Evaluation of Bilayer Tablets Of Sitagliptin Phosphate. International Journal of Pharmaceutical Sciences. 2023;1(01):1-2.
- Janczura M, Sip S, Cielecka-Piontek J. The development of innovative dosage forms of the fixed-dose combination of active pharmaceutical ingredients. Pharmaceutics. 2022 Apr 11;14(4):834.
- Mazel V, Tchoreloff P. Role of precompression in the mitigation of capping: a case study. Journal of Pharmaceutical Sciences. 2020 Oct 1;109(10):3210-3.
- Sarfraz RM, Khan HU, Mahmood A, Ahmad M, Maheen S, Sher M. Formulation and evaluation of mouth disintegrating tablets of atenolol and atorvastatin. Indian journal of pharmaceutical sciences. 2015 Jan;77(1):83.
- Zaid AN, Rowa’J AR, Ghoush AA, Qaddumi A, Zaaror YA. Weight and content uniformity of lorazepam half-tablets: A study of correlation of a low drug content product. Saudi Pharmaceutical Journal. 2013 Jan 1;21(1):71-5.
- Wahl PR, Peter A, Wolfgang M, Khinast JG. How to measure coating thickness of tablets: Method comparison of optical coherence tomography, near-infrared spectroscopy and weight-, height-and diameter gain. European Journal of Pharmaceutics and Biopharmaceutics. 2019 Sep 1;142:344-52.
- Zomenko O, Gubenia O, Chepeliuk O, Herasymenko D. Effect of compression modes on tablet strength and friability. Ukrainian Journal of Food Science. 2024 Jan 1;12(1).
- Nikolin B, Imamović B, Medanhodzić-Vuk S, Sober M. High perfomance liquid chromatography in pharmaceutical analyses. Bosn J Basic Med Sci. 2004 May;4(2):5-9. doi: 10.17305/bjbms.2004.3405. PMID: 15629016; PMCID: PMC7250120.