APPLICATION OF MODIFIED USP APPARATUS I AND IN SITU FIBER OPTIC ANALYSIS FOR DRUG RELEASE FROM IBUPROFEN NANOSPHERES
Objective: The main objective of this study was to ascertain the applicability of the modified USP Apparatus I and in situ fiber optic UV analysis for in vitro release testing of ibuprofen (model drug) nanospheres (IbNS).
Methods: IbNSwere prepared by solvent displacement and utilizing an ultrasonicator at 20KHz for 15 minutes. Characterization of the prepared IbNSinvolved particle size and shape analysis. Drug excipient compatibility was checked through differential scanning calorimeter (DSC). The accuracy, precision,and IbNS release profile obtained with the modified USP apparatus I using in situ fiber optics were compared to the traditional method of sample analysis.
Results: Results also showed the spherical shape of the IbNS(80% between 150-300 nm). DSC showed no interaction between the ingredients used in the formulation process. The fiber optics technique was accurate and precise. Percentage drug release obtained using fiber optics analysis was statistically significant (p=1.0232), and higher as compared to that obtained using the traditional siphoning method. This difference was attributed to loss of nanospheres during the pipetting (separation process)and manual errors in the traditional analysis method.
Conclusion: Fiber optics dip probe technique along with the modified USP apparatus I could be a new and better way for analysis of nano-formulations.
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