Abstract
Purpose: To evaluate the usefulness of the flow-through cell apparatus for testing commercial vaginal tablets containing poorly water-soluble clotrimazole. Methods: The effect of experimental conditions (type of dissolution medium, flow rate and positioning of the tablet) on the dissolution profile of clotrimazole were examined and optimal parameters for conducting the experiments were determined. The amount of drug released was analyzed by high performance chromatography (HPLC) at 210 nm. The usefulness of the flow-through cell apparatus was compared to FDA recommended paddle apparatus. Results: Using acetate buffer pH 5.2 containing 1 % SDS, both methods gave different dissolution profiles. The paddle apparatus tended to give faster rate of dissolution (approx. 88.5 % during the first 20 min of the experiment), which was probably caused by higher agitation and greater surface area of the drug-dissolution medium in a vessel. In the flow-through cell method, total drug release was definitely slower and was observed after 2 to 5 h; at a flow rate of 16 ml/min, more than 80 % of the drug dissolved after 30 min of the test. It was noticed that raising the flow rate of the dissolution medium caused significantly higher drug release. Conclusion: The results demonstrate that the flow-through cell method is reproducible and can be successfully used for evaluating in vitro dissolution of clotrimazole from non-modified release tablets. The slower rate of dissolution obtained in the flow-through cell method would help to distinguish between different formulations.
Highlights
In vitro dissolution study is an official test for evaluating drug release from tablet and capsule dosage forms
Complete disintegration of the tablets in 0.1 M HCl was occurred after 5 ± 0.4 min, and in acetate buffer pH 5.2 containing 1 % Sodium dodecyl sulfate (SDS), this was achieved after 8 ± 0.6 min
Flow rate and type of dissolution medium exert a fundamental influence on dissolution profile, but different positioning of the tablet in the cell did not have significant impact on release behaviour
Summary
In vitro dissolution study is an official test for evaluating drug release from tablet and capsule dosage forms. The flow-through cell apparatus is a relatively new method for dissolution studies and has been officially included in the United States and European Pharmacopeia as apparatus 4 [2,7]. It consists of a pump which forces the release medium upwards through a vertically positioned flow-through cell, a water bath and a reservoir filled with the release medium [8,9]. Since the United States and European Pharmacopeia provide only limited information about apparatus 4 test conditions, the influence of some experimental parameters, such as type of dissolution medium, flow rate and positioning of the tablet, on the dissolution profile of clotrimazole was examined
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
