In Vitro Release Kinetics Study of Different Brands of Esomeprazole Sustained Release Tablets Available in Bangladesh
AbstractCommercially available four national and four international brands of esomeprazole magnesium sustained release matrix tablets were studied in simulated gastric medium (pH 1.2) for 2 hours and simulated intestinal medium (pH 6.8) for 8 hours time period using USP reference dissolution apparatus. All the national and international brands complied with the USP in-vitro dissolution specifications for drug release in simulated gastric medium. However, one of the national brands (Code: MP-1) and one of the international brands (MP-7) failed to fulfill the official requirement of 80% drug release within 8th hour in simulated intestinal medium. Drug release of that national and international brand were 70.49% and 67.05% respectively within the specified time period, however one national brand (Code: MP-4) released 103.46 % drug within 8th hour in intestinal medium. Drug release profiles were analyzed for zero order, first order and Higuchi equation to reveal the release kinetics perspective of esomeprazole magnesium sustained release matrix tablets. It was found that zero order release kinetics was the predominant release mechanism than first order and Higuchi release kinetics for those brands (Code: MP-2, MP-3, MP-4, MP-5, MP-6 and MP-8) which complied with the USP in vitro dissolution specification for drug releases. On the other hand, first order release kinetics was predominant for one national and also one international non compliant brands (Code: MP-1 and MP-6).
Key Words: In vitro dissolution; Sustained release; Market preparations; Kinetic analysis; Esomeprazole; National brand; International brand.
Stamford Journal of Pharmaceutical Sciences Vol.2(1) 2009: 27-31
Each author must agree to this statement
Authorship: This manuscript is the original work of the authors, each of whom has read and approved of the work. Each author satisfied the requirements contained in 'Author Guidelines' having participated sufficiently in the work to take public responsibility for the content. This participation includes:
- Conception or design of the study, or analysis and interpretation of data, or both
- Drafting the article or revising it for critically important intellectual content
- Approval of the final 'to be published' version
All authors must take responsibility for the integrity of the work. Participating solely in the collection of data does not justify authorship.
Prior publication: This work is not currently under consideration by any other journal. Information about prior publication of any part of this work, or inclusion of patients detailed herein in any other work, has been provided in the cover letter.
Conflict of interest: Details of any financial or other relationship between any author and any other party that may lead to a conflict of interest with the subject or any materials mentioned in this article have been disclosed in the cover letter.