Volume : 12, Issue : 12, December- 2025

Title:

FORMULATION AND EVALUATION OF FAST DISSOLVING TABLET OF DAPAGLIFLOZIN

Authors :

Md Nakib Azam*, Rahul Mathur, Dr. Jagdish Chandra Rathi

Abstract :

The present work aimed to enhance the solubility of dapagliflozin through the formation of inclusion complexes with β cyclodextrin prepared in varying ratios by the physical mixture method. Dapagliflozin was characterized as a yellow, odorless, slightly bitter crystalline solid with a melting point in the range of 67–70 °C. Its physicochemical properties were evaluated, including solubility in different media, partition coefficient (Log P = 2.6, indicating moderate lipophilicity), and UV absorption maximum at 221 nm. A calibration curve was established in phosphate buffer (pH 7.4), and compatibility studies confirmed the suitability of selected excipients for fast dissolving tablet formulation. Pre compression parameters such as bulk density, tapped density, Carr’s index, Hausner’s ratio, and angle of repose demonstrated good flow properties across all formulations. Post compression evaluation revealed acceptable ranges for weight variation (202.3–212.2 mg), thickness (2.61–2.78 mm), hardness (2.5–2.8 kg/cm²), friability (0.298–0.395%), disintegration time (23.17–34.62 s), drug content (94.14–99.16%), wetting time (32.17–44.16 s), and water absorption ratio (54.27–58.61%). In vitro dissolution studies showed that cumulative drug release varied among formulations (FDT 1 to FDT 6), with FDT 6 exhibiting the highest release of 97.14% within 30 minutes. These findings confirm that inclusion complexation with β cyclodextrin significantly improves the solubility and dissolution profile of dapagliflozin, supporting its potential application in fast dissolving tablet formulations for enhanced therapeutic efficacy.
Keywords: Dapagliflozin, Superdisintegrants, Glycaemia, Fast Dissolving Tablet, Solubility

Cite This Article:

Number of Downloads : 10

References:

1. Ayush Kartikey, Anshita Gupta, Dr. Vivek Gupta. Formulation and evaluation of bilayer tablet of dapagliflozin and vildagliptin. Jptcp, 2023, 30(1):714-723.
2. Kajal More, Amreen Khan, Umesh Atneria, Neeraj Sharma, Dharmendra Solanki. Formulation and Evaluation of Fast Dissolving Tablet of Dapagliflozin. Ijsdr, 2024;9(4): 1466-1472.
3. Gadhawala Sofiza Z, Maulik R. Mehta. Formulation and Characterization of Sublingual Film of Dapagliflozin Propanediol Monohydrate. International Journal of Pharmaceutical Research and Applications. 2023;8(6): 2781-88.
4. Patil, M R. Gujarathi, N A. Rane, B R. (2014) “Formulation And Evaluation of Mouth Dissolving Tablet: Review Article”, Pharma Science Monitor, 5(2),9
5. Duppala, L. Girinath, S K. Kumar, D M. (2016) “Fast Dissolving Dosage Forms: An Overview” World Journal of Pharmaceutical Research, 5(10),1185-1186.
6. Singh, S. (2014) “Review on Fast Dissolving Tablets”, International Journal of Pharmamedix India, 2(3),819-820.
7. Khanna, K. Xavier, G. Joshi, S K. Patel, A. Khanna, S. Goel, B V. (2016) “Fast Dissolving Tablets- A Novel Approach” International Journal of Pharmaceutical Research Allied Sciences, 5(2),311-312.
8. Masih, A. Kumar, A. Singh, S. Tiwari, A K (2017) Fast Dissolving Tablets: A Review” International Journal of Current Pharmaceutical Research, 9(2),8.
9. Saxena, S. Yadav, N (2017) Fast Dissolving Tablets: A Big Turn in Pharmaceutical Industry” Research and Reviews Journal of Pharmacy and Pharmaceutical Sciences, 6(1),26.
10. Carrier, R L. Miller, L A. Ahmed, I. (2007) The utility of cyclodextrins for enhancing oral bioavailability, J Control Release, 123,78-99.