Abstract:
The aim of this research attempts was to improve the micrometric properties and solubility enhancement of spherically agglomerated crystals of Aceclofenac by using spherical agglomeration technique. The oral route of administration is the most important method of administering drugs for systemic effects. In this, the solid dosage form, particularly, tablets are the dosage form of a choice because of their special characteristics like unit dosage form with greatest dose precision and least content variability, lower cost, easy administration by a patient Aceclofenac is an orally effective non-steroidal anti-inflammatory drug (NSAID) of the phenyl acetic acid group which possesses remarkable anti-inflammatory, analgesic and antipyretic properties. Aceclofenac agglomerates were prepared with Poloxamer 188 and PEG 4000 using acetone-dichloromethane (DCM), water as the crystallization system. Various process variables such as selection of bridging liquid and good solvent, agitation speed, agitation time and mode of agitation of bridging liquid were optimized. The prepared aceclofenac spherical agglomerates were evaluated by micromeritic properties like optical microscopy, tapped density, bulk density, Carr’s index, drug content, and also carried out by FTIR, DSC, PXRD pattern, and Electron Scanning microscopy. The conclusion of this study was the agglomerates of Aceclofenac prepared with PEG 4000 and Poloxamer 188 showed improved solubility and dissolution in addition to improving the micromeritic properties. The solubility study reveals that the solubilizing efficiency of hydrophilic polymers enhances the drug solubility significantly as compare to plain agglomerates and Aceclofenac alone. The increase in drug release could be attributed to deposition of polymers on the recrystallized surface and better wettability of spherical agglomerates.

Keywords: Aceclofenac, DCM, PXRD, Spherical Agglomerates, Poloxamer 188.