Formulation, Evaluation and Optimization of Ibuprofen Micropellets using 32 full factorial design

This  study was  focused over  the  designing  of sustained  release  HPMC  K100M  micropellet dosage form for  Ibuprofen which is an anti-inflammatory agent and broadly used for treating mild and severe pains. The approach of this study was to make a comparative evaluation among polymers  &  excipients  and  to  assess  the  effect  of  physicochemical  nature  of  the  active ingredients on the drug release profile. The prototype micropellets were obtained using drum pelletizer at 300 rpm. Percentage of water in binding liquid, i.e. IPA, is varied from 95 to 99% and  the effect  over  various parameters,  such as  particle size,  entrapment,  bulk  density and particle  shape,  were observed. Concerning the results of prototype preparation of Ibuprofen micropellets  were  prepared  using  HPMC  K100M,  as  release  retardant,  in  three  different concentrations i.e. 16.7%, 33.3% & 50%. Formulated micropellets showed particle size in the range of 275-284µm, bulk density (0.74-0.82 g/ml), % yield (25.9 -58.3%) & % entrapment (32.8-34.3%). Formulations showed the   maximum   desirability 0.996. Dry suspension formulation  parameters  such  as  pH  (5.15),  Viscosity  (450  cps),  Redispersibility  (5)  & Sedimentation volume (0.46 ml), was  found in  range. Formulation           PIH   were selected as the best   optimized  formulation  and  evaluated  for  In-vivo  parameters,  results  inferred  good sustainability with p>0.0001. Formulated micropellet showed sustained in-vitro dissolution rate, due to optimized polymer concentration. The micropellets were stable at 40°C±2°C/75%±5% RH as per ICH guidelines, after 3 months.