Preparation and evaluation of oral controlled release mucoadhesive Microspheres of Ketorolac Tromethamine

Potu Appa Rao Rao, Prabhakar Reddy Veera Reddy

Abstract


Recently, lot of emphasis is being laid on oral controlled release multiple unit particulate (MUP) dosage forms, for their significant and potential benefits.  Ketorolac tromethamine (KTM) is a potent non-narcotic analgesic and anti-inflamatory drug administered orally in multiple divided doses (10 mg four times a day) for the management of mild to moderate post-operative pain. KTM’s short biological half-life demands frequent administration of the drug leading to poor patient compliance and inadequate pain management. Hence, the present investigation was undertaken to develop and evaluate oral controlled release mucoadhesive microspheres by ionotropic gelation method using natural and biodegradable polymers such as sodium carboxy methyl cellulose (Na CMC) and sodium alginate (SA). The influence of various formulation factors on the drug entrapment  efficiency,  in vitro drug release, micromeritic properties, and  mucoadhesion ability  was investigated. Scanning electron micrographs of alginate beads loaded with drug exhibited rough surface morphology and  sizes were found to be  in the range of 842 to 1265 µm. Among all the formulations, the drug loaded microspheres of formulation CA6   showed the highest drug release retarding effect over a period of  8  hours.  The drug-polymer compatibility studies and solid state properties were investigated by Fourier transform infrared spectroscopy (FTIR), and differential scanning calorimetry (DSC) X- Ray diffraction techniques (X-RD).


Keywords


Microspheres, Ketorolac tromethamine, controlled release, Ionotropic gelation technique, FTIR

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References


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