Studying the effect of dispersed drug crystal in the organic phase on the encapsulation by solvent evaporation technique (3) Independent models as tools for studying the drug release profiles

Abstract

Aspirin dissolution profiles from different particle size ranges of Eudragit RS100 microcapsules were studied in relation to the studied microcapsule structures. The results showed that there is no burst effect and the total amount of drug released from different particle size ranges prepared with the same or different TDC are more than 80% during 12 hr. The release data indicated the closest of the dissolution profile in every case. The values of standard deviation at every time unit were also used as an indication for the release data distribution around the mean of drug release.  The model independent methods were used to prove the dissolution profile similarity of Aspirin from different particle size ranges microcapsules prepared by using the same theoretical drug content. Accordingly the mean dissolution profile of Aspirin from different particle size ranges of Eudragit RS100 prepared by using the same TDC was used to represent the drug release profile and also to study the effect of increasing TDC. The mean release data showed the closest of the dissolution profiles from different products prepared by using different TDC. Again the independent models were used to prove the similarity of the dissolution profile of Aspirin from different Eudragit RS100 microcapsules prepared on using different TDC. Accordingly it was concluded that the overall Aspirin dissolution profile can be used to represent the drug release profile from different particle size ranges of Eudragit RS100 microcapsules prepared by using the same or different TDC.