Olmesartan medoxomil (OLM), currently only available as tablet dosage forms, is on the US Pharmacopoeia (USP) priority request list for extemporaneously compounded monographs. Three aims guided this study: i) formulate a stable extemporaneous suspension that can be prepared by pharmacists, ii) establish the beyond use date (BUD) based on stability study data, and iii) rigorously adhere to the USP Technical Proposal for Compounded Preparation Monograph Development (CPMD). A chemical stability indicating RP-HPLC assay was developed and validated for an OLM suspension made with ORA-Plus®, ORA-Sweet® and water (1:2:1, by volume). A 90-day study was conducted according to the USP technical proposal for CPMD. Physical and microbiological stability were assessed with visual and olfactory evidence. Extemporaneously prepared OLM suspensions were found to have a maximum degradation of 5.5% after 90 days when stored at room temperature (21.2 °C), and 2.9% after 90 days when stored at USP refrigerated conditions. There were no apparent changes in color and odor. All of the preparations were easily re-dispersible, and caking was not observed for either storage condition. The chemical stability data, organoleptic properties, and lack of any evidence indicative of microbial contamination corroborate the assignment of a BUD of 90 days, consistent with USP guidelines.
|Commitee:||Nieto, Marcelo, McPherson, Timothy|
|School:||Southern Illinois University at Edwardsville|
|School Location:||United States -- Illinois|
|Source:||MAI 81/3(E), Masters Abstracts International|
|Keywords:||BUD, Extemporaneous suspension, Olmesartan medoxomil, RP- HPLC, Stability, USP|
Copyright in each Dissertation and Thesis is retained by the author. All Rights Reserved
The supplemental file or files you are about to download were provided to ProQuest by the author as part of a
dissertation or thesis. The supplemental files are provided "AS IS" without warranty. ProQuest is not responsible for the
content, format or impact on the supplemental file(s) on our system. in some cases, the file type may be unknown or
may be a .exe file. We recommend caution as you open such files.
Copyright of the original materials contained in the supplemental file is retained by the author and your access to the
supplemental files is subject to the ProQuest Terms and Conditions of use.
Depending on the size of the file(s) you are downloading, the system may take some time to download them. Please be