Preparation and Characterization of Co-Grinded Mixtures of Aceclofenac and Neusilin US2 for Dissolution Enhancement of Aceclofenac |
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Authors: | Ambarish H Vadher Jolly R Parikh Rajesh H Parikh Ajay B Solanki |
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Institution: | (1) A. R. College of Pharmacy and G. H. Patel Institute of Pharmacy, Vallabh Vidyanagar, 388 120, India;(2) Institute of Science and Technology for Advanced Studies and Research (ISTAR), Valllabh Vidyanagar, 388 120, India;(3) Present address: Formulation and Development Department, Alembic Research Centre, Alembic road, Vadodara, 390 003, India;(4) Ramanbhai Patel College of Pharmacy, Education Campus, Changa, 482 321, India |
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Abstract: | The present study was carried out with a view to enhance the dissolution of poorly water-soluble BCS-class II drug aceclofenac
by co-grinding with novel porous carrier Neusilin US2. (amorphous microporous granules of magnesium aluminosilicate, Fuji Chemical Industry, Toyama, Japan). Neusilin US2 has been used as an important pharmaceutical excipient for solubility enhancement. Co-grinding of aceclofenac with Neusilin
US2 in a ratio of 1:5 was carried out by ball milling for 20 h. Samples of co-ground mixtures were withdrawn at the end of every
5 h. and characterized for X-ray powder diffraction, differential scanning calorimetry, and Fourier-transform infrared spectroscopy.
The analysis revealed the conversion of crystalline aceclofenac to its amorphous form upon milling with Neusilin US2. Further, in vitro dissolution rate of aceclofenac from co-ground mixture was significantly higher compared to pure aceclofenac. The accelerated
stability study of co-ground mixture was carried out at 40°C/75%RH for 4 weeks, and it showed that there was no reversion
from amorphous to crystalline form. Thus, it is advantageous to use a porous carrier like Neusilin US2 in improvement of dissolution of poorly soluble drugs. |
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Keywords: | aceclofenac co-grinding dissolution Neusilin US2 porous carrier |
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