Development, characterization and evaluation of empagliflozin spherical agglomerates using spherical agglomeration technique
Kavuluru Venkata Swathi Krishna and Kothapalli Bonnath Chandra Sekhar
The present research work embodies the preparation of spherical agglomerates of empagliflozin with increased solubility, flow and compression properties using novel crystallization technique. The drug was dissolved in 30ml dichloromethane (good solvent) and stirred. 100ml of water (poor solvent) was added and continued stirring. 5ml of chloroform (bridging liquid) was added and stirred at 1000rpm for 40minutes to precipitate empagliflozin. The precipitated particles were filtered and dried at 40 °C. Spherical agglomerates were characterized by IR spectroscopy, X-ray diffraction studies, DSC and SEM and its results showed that no physical or chemical interaction existed in the prepared agglomerates. A Fourier transform infrared (FTIR) study indicated compatibility of drug with the excipients. The agglomerates can be made directly into tablets because of their excellent flowability. Directly compressed tablets of the Empagliflozin agglomerates exhibited hardness, friability and weight variation appropriately along with improved drug release characteristics. Among the different control release polymers Caesalpinia spinosa (natural mucoadhesive polymer) showed increased drug release retarding capacity. F3 showed the satisfactory results and have better sustainability. The developed agglomerates were spherical with smooth surface and dissolution profile was faster and exhibited improved solubility along with proper micromeritic properties than pure drug. The significantly improved micromeritic properties compared to the plain drug suggested its suitability for direct compression.
How to cite this article:
Kavuluru Venkata Swathi Krishna, Kothapalli Bonnath Chandra Sekhar. Development, characterization and evaluation of empagliflozin spherical agglomerates using spherical agglomeration technique. Pharma Innovation 2018;7(3):202-207.