Dissertation/Thesis Abstract

Stability Study of Olmesartan Medoxomil Extemporaneous Suspension
by Bhattarai, Prapanna, M.S., Southern Illinois University at Edwardsville, 2019, 61; 22589025
Abstract (Summary)

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.

Indexing (document details)
Advisor: Kolling, William
Commitee: Nieto, Marcelo, McPherson, Timothy
School: Southern Illinois University at Edwardsville
Department: Pharmaceutical Sciences
School Location: United States -- Illinois
Source: MAI 81/3(E), Masters Abstracts International
Source Type: DISSERTATION
Subjects: Pharmaceutical sciences
Keywords: BUD, Extemporaneous suspension, Olmesartan medoxomil, RP- HPLC, Stability, USP
Publication Number: 22589025
ISBN: 9781088364475
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