ORAL EXTENDED RELEASE DRY SUSPENSION OF PARACETAMOL LOADED MICROSPHERES

Background: A novel reconstitutable suspension of Paracetamol loaded microspheres was prepared using ethyl cellulose as a release controlling polymer and by solvent evaporation technique for the relief of osteo-arthritic pain. Objective: The formulation was developed to enhance patient compliance of population suffering from dysphagia or have difficulty in swallowing oral solid dosage forms like tablets and capsules. Method: Microspheres were evaluated for percent yield, drug loading, and entrapment efficiency, in vitro drug release profile and particle size. The microspheres were formulated as a dry oral suspension which has to be reconstituted at the time of use. Result: The particle size of microspheres was in the range of 550 -700 μm. The entrapment efficiency was in the range of 82.95- 95.56% and the yield obtained was 91.13-98.76%. The dissolution studies of selected trial showed a percent cumulative drug release of not less than 85% at the end of 3 hours. Formulation trial P5containing 4% xanthan gum, 5% purified talc and 6 mg sucralose gave a suspension having good flow property, viscosity, sedimentation value, redispersibility and palatability. The dissolution studies showed a 92.43% cumulative drug release in 3 hours. Comparative dissolution profile with marketed preparation gave a similarity factor of 78. Conclusion: The objective of developing a novel patient-compliant oral suspension for patients having difficulty in swallowing solid dosage forms was achieved.