Design, development and evaluation of immediate release tablet of ibuprofen solid dispersion

At present approximately 40% of new chemical entities identified by pharmaceutical companies are poorly water soluble. The formulations of poorly water soluble drugs (BCS) Class II for oral delivery presents a greatest challenge to the formulation scientists. Oral bioavailability depends on its solubility and dissolution rate. Several techniques have been developed over the years to enhance the dissolution of the drug such as solid dispersion, micronization, solubilization, and complexation with polymers, salt formation using prodrugs and adding surfactant. In present study the attempts have been made to increase the dissolution of BCS class II drug Ibuprofen using hydrophilic polymers namely polyethylene glycol (PEG) 6000 and polyvinyl pyrrolidone (PVP) K30 by microwave induced solid dispersion and conventional fusion method. Drug-polymer complex was prepared using batch method. Maximum dissolution rate was obtained at complex prepared from (Ibuprofen+PEG6000+SLS). A successful solubility enhancement of drug complex was confirmed by taking drug release in 7.2 pH phosphate buffer. The drug was characterized according to different compendial methods, on the basis of identification by UV spectroscopy, organoleptic properties and other tests. In this microwave induced solid dispersion exhibit significant improvement in solubility and dissolution rate compared to that of pure drug. Thus microwave technology offers a simple, efficient, shorter preparation time, solvent free promising alternative method to solid dispersion of Ibuprofen with significant enhancement of the in vitro dissolution rate. After that among the all formulation batches, solid dispersion (F8) was selected for further tablet formulation batches with considerable increase in drug release as compared to marketed formulation , nine formulations were developed and studied. The values of pre-compression parameters evaluated, were within prescribed limits and indicated good free flowing properties. The data obtained of post-compression parameters such as weight variation, hardness, friability, wetting time, water absorption ratio, content uniformity, disintegration time and dissolution and was found to superior over conventional formulation. The F9 batch with disintegrating time 28.19±0.66 second and dissolution 99.89±1.06 % was selected as optimized formulation and was found superior. When F9 formulation was compared with marketed formulation it gives highest percent drug release than marketed formulation. Batch F9 was also subjected to stability studies for three months and was tested for its disintegrating time, drug contents and dissolution behaviour monthly. It was observed that the contents of the tablets remained same. By an appropriate selection and combination of excipients it was possible to obtained immediate release tablets.