Formulation and evaluation of osmotic drug delivery system of ibuprofen.
Keywords:
Ibuprofen, Osmogent, Osmotic drug delivery system, Wet granulationAbstract
Aim: The present work was aimed to formulate and evaluate osmotic pump delivery system of Ibuprofen to provide a uniform concentration of drug at the absorption site and thereby maintain the plasma concentration within therapeutic range, which minimizes side effects and reduces the frequency of administration.
Material and Methods: In the present work, 5 formulations (F1 to F5)of Ibuprofen osmotic drug delivery systems(ODDS) were prepared using two osmogens (NaCl and KCL) in two concentrations and a control F6 (without osmogens) by wet granulation technique. The excipients used in this study did not alter physicochemical properties of the drug, as tested by FTIR. Prior to compression, the prepared granules were evaluated for flow and compression characteristics. After compression, the tablets were evaluated for hardness, thickness, weight variation, friability, percentage of weight gain, drug content, in vitro release and stability studies.
Results: The results revealed that the pre-compression and post-compression parameters are within the limits. Among all the formulations, F3 showed a controlled drug release of 63.54% at the end of 10th hour. The results of optimized formulation (F3) subjected to stability studies for 60 days at 27º±2ºC/60 ± 5% RH and 50º±2ºC/75 ± 5% RH showed that there was no significant change in the drug content and percentage drug release and the product was stable even after 2 months.
Conclusions: From the study, it was concluded that Ibuprofen osmotic pump tablet prepared with potassium chloride (10%) as osmogent and cellulose acetate as coating polymer may be considered as a suitable alternative to currently available formulations of Ibuprofen.
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