Background: Olmesartan medoxomil (OLM) is only available in the United States as tablets. The United States Pharmacopoeia (USP) has placed OLM on its priority list of preparations that require stability data to support practitioner compounding. Objective: The purpose of the study was to develop a stability-indicating assay and then determine the beyond-use date (BUD) for an extemporaneous OLM suspension. Methods: A reverse-phase high-performance liquid chromatography (HPLC) assay was developed and validated according to guidelines for USP official compounded monographs. OLM 2 mg/mL suspensions were compounded with Ora-Sweet and Ora-Plus and stored at room temperature or in a refrigerator. Suspensions were assayed periodically over 90 days for OLM concentration and observed for physical stability. The pH was measured at the beginning and end of the study. Results: The OLM concentration remained above 97% of the starting concentration for 90 days when stored in the refrigerator and above 94% of the starting concentration for 90 days when stored at room temperature. The suspension pH did not change and indicators of physical stability were unchanged for 90 days. Conclusion: OLM 2 mg/mL suspensions were chemically and physically stable at room temperature and in the refrigerator for 90 days. The BUD may be set at 90 days under either storage condition.
MillsKTStefanescuAHeJ. The global epidemiology of hypertension. Nat Rev Nephrol. 2020;16:223-237. doi:10.1038/s41581-019-0244-2
2.
Centers for Disease Control and Prevention. National Center for Health Statistics. Health, United States, 2019—data finder: Table 022. Accessed August 1, 2021. https://www.cdc.gov/nchs/hus/contents2019.htm
3.
HansenMLGunnPWKaelberDC. Underdiagnosis of hypertension in children and adolescents. JAMA. 2007;298:874-879. doi:10.1001/jama.298.8.874
4.
MireDESilfaniTNPugsleyMK. A review of the structural and functional features of olmesartan medoxomil, an angiotensin receptor blocker. J Cardiovasc Pharmacol. 2005;46:585-593. doi:10.1097/01.fjc.0000180902.78230.fd
5.
SchieleJTQuinzlerRKlimmHDPruszydloMGHaefeliWE. Difficulties swallowing solid oral dosage forms in a general practice population: prevalence, causes, and relationship to dosage forms. Eur J Clin Pharmacol. 2013;69:937-948. doi:10.1007/s00228-012-1417-0
6.
PrajapatiSTJoshiHAPatelCN. Preparation and characterization of self-microemulsifying drug delivery system of olmesartan medoxomil for bioavailability improvement. J Pharm (Cairo). 2013;2013:728425. doi:10.1155/2013/728425
7.
BajerskiLRossiRCDiasCLBergoldAMFröehlichPE. Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug, olmesartan medoxomil: comparison between commercial tablets. AAPS PharmSciTech. 2010;11:637-644. doi:10.1208/s12249-010-9421-0
<795> Pharmaceutical compounding—nonsterile preparations. In: United States Pharmacopeia: The National Formulary. United States Pharmacopeial Convention, Inc; 2021:7025.
10.
<1225> Validation and compendial procedures. In: United States Pharmacopeia: The National Formulary. United States Pharmacopeial Convention, Inc; 2021:8166.
11.
BegSSharmaGKatareOPLohanSSinghB. Development and validation of a stability-indicating liquid chromatographic method for estimating olmesartan medoxomil using quality by design. J Chromatogr Sci. 2015;53:1048-1059. doi:10.1093/chromsci/bmu165
12.
SharmaRNPancholiSS. RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions. Acta Pharm. 2010;60:13-24. doi:10.2478/v10007-010-0010-2
13.
RaneVPPatilKRSangshettiJNYeoleRDShindeDB. Stability-indicating LC method for the determination of olmesartan in bulk drug and in pharmaceutical dosage form. Chromatographia. 2008;69:169-173. doi:10.1365/s10337-008-0849-2
