Olmesartan medoxomil (OLM), an Angiotensin Receptor Blocker (ARB), is one of the newer drugs found effective in the management of hypertension and congestive heart failure. Currently, the drug is only available as a tablet dosage form. However, there are some individuals who may have trouble swallowing intact tablets, like pediatric, geriatric, or dysphagic patients. Often liquid formulations are compounded extemporaneously for such patients. Because of the limited solubility and rapid hydrolysis of the ester, it is not suitable to formulate OLM as an aqueous solution. In these cases, a better option may be to formulate the drug as a suspension. However, there are no literature reports on the stability of the OLM extemporaneous suspension. The goal of this project is to formulate an extemporaneous suspension and develop and validate the stability indicating assay to determine an acceptable beyond use date. We have developed and validated an assay according to United States Pharmacopoeia (USP) guidelines which address system suitability, accuracy, specificity, linearity and range, and robustness acceptance criteria for the RP-HPLC method. We have also verified the intra- and inter-day stability of the standard and assay solutions, as well as the homogeneity of the compounded suspension. Preliminary data obtained at the time of this submission indicates that the proposed formulation will be stable for at least 30 days.<br/>

Stability study of an extemporaneous suspension of olmesartan medoxomil

2019 Spring National Meeting

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