Manuscript Title:

MELT GRANULATION AND LIQUISOLID TECHNIQUE APPROACH FOR THE ENHANCEMENT OF SOLUBILITY OF EDOXABAN

Author:

K RAJESH KUMAR, Dr. MOHD. JAVED NAIM

DOI Number:

DOI:10.17605/OSF.IO/8XZ4T

Published : 2022-03-27

About the author(s)

1. K RAJESH KUMAR - Research Scholars, Bhagwant University, Ajmer, Rajasthan, india.
2. Dr. MOHD. JAVED NAIM - Research Scholars, Bhagwant University, Ajmer, Rajasthan, india.

Full Text : PDF

Abstract

The objective of the present work is to obtain improve the solubility and dissolution profile of poorly soluble drug, Edoxaban using liquid solid compacts and melt granulation techniques. The solubility studies of Edoxaban were studies in non-liquid vehicles, Liquisolid system of Edoxaban was prepared by using Maisine CC, Avicel pH, Aerosil, SSG and by melt granulation technique using Gelucire 48/16 pellets, Polyox WSR N-80. The formulations were evaluated for drug excipient interactions, flow properties, and general quality control tests of tablets using Fourier transform infrared (FTIR) spectroscopy, differential scanning calorimetry (DSC). In vitro dissolution studies were performed at 37°C ± 0.50°C, taking 900 ml of 0.1N HCl as a dissolution medium at 50rpm measured at 296nm. Stability studies were performed at 40°C and 75% RH for three months. Solubility data obtained that Maisine CC (744.2327µg/mL) & Tween 80 (668.0290 µg/mL) were found to have good solubility with Edoxaban. The FT-IR spectra of the drug and polymer showed that there was no shift in the major peaks. The formulation was found to comply with Indian pharmacopeial limits, Disintegration of all the capsules occurred within 73 sec and 85 sec. LSF5 and MGF4 showed the better results. No significant difference was seen in the tablet properties, and drug release profile after storage for 3 months.


Keywords

Edoxaban, Maisine CC,Avicel pH,Aerosil, Gelucire 48/16 pellets, ,Liquidsolid system, melt granulation.