ABSTRACT
OBJECTIVE:To compare the relative bioavailability of 2 kinds of domestic oxaprozin enteric tablets.METHODS:20 healthy volunteers were administered with single oral dose of trial tablet 400g and reference tablet 400g by crossover design,whose plasma oxaprozin level was determined by HPLC.The pharmacokinetic parameters and bioavailability of oxaprozin enterosoluble tablets were calculated by 3p97 software.RESULTS:The pharmacokinetic parameters of tested enteric tablets vs.reference tablets were as follows,t 1/2?(73.468?24.354),(73.556?24.406)h,t max(13.275?8.012),(13.200?15.154)h,C max(44.283?7.535)、(45.429?15.107)?g/ml,AUC 0～Tn(4471.792?1387.724),(4234.328?1741.380)(?g?h)/ml,AUC 0～inf(5040.407?2092.744),(4858.292?2423.656)(?g?h)/ml;No significant differences were noted between 2 tablets.The relative bioavailability of tested tablet was(112.8?38.5)%.CONCLUSION:2 kinds of oxaprozin enterosoluble tablets were bioequivalent.
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OBJECTIVE: To observe the effects of different types of carbomers on percutaneous permeability of oxaprozin gels in vitro and to opitmize the formulation of oxaprozin gel. METHODS: The permeability test in vitro was carried out by using Franz diffusion cell with rats' ex vivo skin as barrier. RESULTS: The ex vivo permeability of oxaprozin gel was the best when the carbomer 940 used as its base material with its ex vivo permeability coefficient at 22.77?g/ (cm2?h) . CONCLUSION : The optimized gel base material can act as bases for the production of oxaprozin gel.
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OBJECTIVE: To study the preparation and quality standard of chitosan-oxaprozin sustained release tablets, and observe the rule of in vitro release of oxaprozin. METHODS:The content of oxaprozin in the tablets was determined by UV - spectrophotometry. RESULTS:The linear range was 2. 5- 15. 0ug/ml. The average recovery was 99. 79% with a RSD of 0. 38%. CONCLUSION: The preparation process of chitosan-oxaprozin sustained release tablet is simple. It is worth expanding the app- lication in clinical practice.
ABSTRACT
Aim An HPLC method was established for the study on pharmacokinetics and bioequivalence of oxaprozin enteric tablet in healthy volunteers.Methods The oxaprozin in plasma was determined using HPLC method following a single oral dose of 400 mg of oxaprozin given respectively to 18 healthy male volunteers in an open randomized crossover design.The pharmacokinetic parameters and relative bioavailability were calculated to evaluate the bioequivalence of 2 preparations.Results AUC_(0-240 h) of oxaprozin tested tablet and reference tablet were(2852.86?871.00)and (2992.84?854.02)?g?L~(-1)?h,C_(max) were(33.48?11.36)and (32.70?7.30)?g?L~(-1),T_(max) were(12.1?5.7)and(13.8?5.8)h,T_(1[]2ke) were(57.11?8.51)and(60.98?7.97)h,respectively.These main pharmacokinetic parameters obtained showed no statistically significant difference between the 2 products.Conclusion The method is simple and sensitive.Both preparations are bioequivalent.