Extemporaneous compounding is routine in pharmacies, and it is essential that the compounding pharmacists and practitioners have information on the formula, compounding directions and stability of the preparations they compound. In the United States, thioguanine is available only in the form of 40 mg tablets and the patient population in which thioguanine is used comprises mostly children. Recognizing the importance of thioguanine as a therapeutic agent and limited stability data for its compounded preparation, the United States Pharmacopoeia (USP) has listed thioguanine in its priority list of compounded preparations monographs (CPM). The goal of the present study was to generate stability data and establish a beyond-use date for compounded thioguanine suspension. Suspensions were compounded using thioguanine tablets, and ORA-Plus® and ORA-Sweet® as vehicles. Three suspensions were stored at room temperature (19-23 °C) and three were stored in refrigerator (4-8 °C). A robust high-performance liquid chromatography (HPLC) method was developed and validated as per USP standards, and was used to test chemical stability of the compounded suspensions. Thioguanine and guanine in suspensions were quantified immediately after compounding and at regular intervals for 90 days. Physical and microbiological stabilities of suspensions were evaluated by inspection of organoleptic properties. Results from the study indicate that average thioguanine levels in suspensions remained above accepted standards (>90 % of initial amount), and guanine formation was within the limits (<2.5 % of thioguanine concentration), for 90 days. There was no statistically significant difference in the amount of thioguanine degraded over the storage period between the suspensions stored at room temperature and in refrigerated conditions. Also, there was no statistically significant difference in the guanine levels of the suspensions at day 0 and day 90 (Independent samples t-tests, p-value > 0.05).
|Commitee:||Kolling, William, Nieto, Marcelo|
|School:||Southern Illinois University at Edwardsville|
|School Location:||United States -- Illinois|
|Source:||MAI 81/11(E), Masters Abstracts International|
|Keywords:||Beyond-use date, Compounding, HPLC, Stability, Thioguanine, USP monograph|
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