Volume : 13, Issue : 10, October – 2026
Title:
FORMULATION AND EVALUATION OF NANOSUSPENSION CONTAINING SOTAGLIFLOZIN
Authors :
Pravat Ranjan Guru, Suprit Mishra, Biswajit Mohapatra, Satya Ranjan Dalai, Sujit Kumar Mohanty
Abstract :
Sotagliflozin is a dual sodium-glucose co-transporter (SGLT-1 and SGLT-2) inhibitor used in the management of diabetes mellitus. However, its poor aqueous solubility may limit its dissolution rate and oral bioavailability. The present study was undertaken to formulate and evaluate a nanosuspension containing Sotagliflozin with the objective of improving its dissolution characteristics and overall pharmaceutical performance.
Sotagliflozin nanosuspensions were prepared using a suitable nanosuspension technique with different concentrations of stabilizers to obtain optimized formulations (F1–F6). The prepared nanosuspensions were evaluated for their physicochemical properties and subsequently compressed into tablets. The powder blends were assessed for pre-compression parameters, including bulk density, tapped density, angle of repose, Carr’s index, and Hausner’s ratio. The compressed tablets were evaluated for post-compression parameters such as weight variation, hardness, thickness, friability, drug content uniformity, disintegration time, and in vitro drug release. All the pre-compression and post-compression parameters were found to be within the acceptable limits prescribed by the Indian Pharmacopoeia (IP), indicating good flow properties, compressibility, and tablet quality.
Among all the formulations, F6 was identified as the optimized formulation based on its superior in vitro dissolution performance. The optimized formulation released 97.73% of Sotagliflozin within 60 minutes, which was higher than that of the other formulations, demonstrating the effectiveness of the nanosuspension approach in enhancing drug dissolution. The improved dissolution profile can be attributed to the reduced particle size and increased surface area of the drug in the nanosuspension system.
In conclusion, the developed Sotagliflozin nanosuspension-based formulation exhibited satisfactory pharmaceutical characteristics and complied with all IP quality specifications. The optimized formulation (F6) showed significantly enhanced drug release, suggesting that nanosuspension technology is a promising strategy for improving the dissolution and potential oral bioavailability of poorly water-soluble drugs such as Sotagliflozin.
Keywords: Sotagliflozin nanosuspension
Cite This Article:
Please cite this article in press Pravat Ranjan Guru et al., Formulation And Evaluation Of Nanosuspension Containing Sotagliflozin.,. Indo Am. J. P. Sci, 2026; 13(10).
REFERENCES:
1. Md. Saddam Hussain, Abdul Baquee Ahmed and Jiban Debnath. Nanosuspension: A Promising Drug Delivery System For Poorly Water Soluble Drug And Enhanced Bioavailability. IJPSR, 2020; Vol. 11(10): 4822-4832.
2. Dhiman, Dharmila S and Thakur, GS: Nanosuspension: A recent approach for nano drug delivery system. Int J Curr Pharm Res 2017; 3(4).
3. Rinku Jayaprakash, K. Krishnakumar, B. Dineshkumar, Rejin Jose, Smitha K Nair. Nanosuspension in Drug Delivery-A Review. Sch. Acad. J. Pharm., 2016; 5(5): 138-141.
4. Wagh KS, Patil SK, Akarte AK, Baviskar DT; Nanosuspension – a new approach of bioavailability enhancement,International Journal of Pharmaceutical Sciences Review and Research, 2011; 8: 60-62.
5. Paun JS, Tank HM; Nanosuspension: An Emerging Trend for Bioavailability Enhancement of Poorly Soluble Drugs. Asian J. Pharm. Tech, 2012; 2(4):157-168.
6. Lakshmi P, Kumar GA; Nanosuspension technology: a review; International Journal of Pharmacy and Pharmaceutical Sciences, 2010; 2:35-40.
7. Praveen Kumar G, Krishna KG; Nanosuspensions: The Solution to Deliver Hydrophobic Drugs. International Journal of Drug Delivery, 2011; 3: 546-557.
8. Pattnaik S, Swain K, Rao JV; Nanosuspensions: a strategy for improved bioavailability. International Journal of Pharmacy and Biological Sciences, 2013; 3: 324-327.
9. Soumya M, Gupta S, Jain R, Mazumder R; Solubility enhancement of poorly water soluble drug by using nano suspension technology. International Journal of Research and Development in Pharmacy and Life Sciences. 2013; 2: 642-649.
10. Kavitha VB, Neethu CS, Dineshkumar B, Krishnakumar K, John A; Nanosuspension Formulation: An Improved Drug Delivery System. Nanoscience and Nanotechnology: An International Journal, 2014; 2: 1-5.
11. Arunkumar N, Deecarman M, Rani C; Nanosuspension technology and its application in drug delivery. Asian Journal of Pharmaceutics 2009; 3:168-173.
12. Date AA, Kulkarni RM and Patravale VB: Nanosuspensions: A promising drug delivery. Journal of Pharmacy & Pharmacology 2018; 56: 827-40.
13. Muller RH, Jacobs C, Kayser O; Nanosuspensions as particulate drug formulations in drug therapy. Rationale for development and what we can expect for the future. Adv Drug Delivery, 2001; 47(1): 3-19.
14. Shid RL, Dhole SN, Kulkarni N, Shid SL;Nanosuspension: A Review. Int J. Pharm. Sci. Rev.Res., 2013; 22(1): 98-106.
15. Komasaka T, Fujimura H, Tagawa T, Sugiyama A and Kitano Y, 2014, Practical method for preparing nanosuspension formulations for toxicology studies in the discovery stage: formulation optimization and in vitro/in vivo evaluation of nanosized poorly water-soluble compounds, Chemical and Pharmaceutical Bulletin, 62(11), 1073-1082, ISSN: 1347-5223.
16. Talat M, Upadhyay P, Omray P, Koteshwara KB and Srivastava ON, 2014, Preparation and Characterization of Nanosuspension of Tamoxifen Citrate for IntraVenous Administration in Drug-Resistant Breast Cancer Cells, Advanced Science Letters, 20(7-9), 1483-1489, ISSN: 1936-7317.
17. Muthu MS and Singh S, 2009, Poly (D, L-Lactide) Nanosuspensions of Risperidone for Parenteral Delivery: Formulation and In-Vitro Evaluation, Current Drug Delivery, 6, 62-68, ISSN: 1875-5704.
18. Shakeel F, Ramadan W and Shafiq S, 2009, Solubility and Dissolution Improvement of Aceclofenac using Different Nanocarriers, Journal of Bioequivalence and Bioavailability, 1(2), 39-43, ISSN:0975-0851.
19. Nakarani M, Misra AK, Patel JK and Vaghani SS, 2010, Itraconazole nanosuspension for oral delivery: Formulation, characterization and in vitro comparison with the marketed formulation, DARU Journal of Pharmaceutical Sciences, 18(2), 84-90, ISSN: 2008-2231.
20. Pandya VM, Patel JK and Patel DJ, 2011, Formulation and Optimization of Nanosuspensions for Enhancing Simvastatin Dissolution Using Central Composite Design, Dissolution Technologies, 18(3), 40-45, ISSN: 1521-298X




