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Stability of Sotalol Hydrochloride in Extemporaneously Prepared Oral Suspension Formulations

Author(s):  Sidhom Madiha B, Rivera Nadya, Almoazen Hassan, Taft David R, Kirschenbaum Harold L

Issue:  Sep/Oct 2005 - Pain Management
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Abstract:  The physical, chemical, and microbial stabilities of extemporaneously compounded oral liquid formulations of sotalol hydrochloride were studied. Sotalol hydrochloride oral liquid suspensions (5 mg/mL) were prepared from commercially available tablets (Betapace) in a 1:1 mixture of Ora-Plus: Ora-Sweet, a 1:1 mixture of Ora-Plus:Ora-Sweet SF, and a 1:2.4 mixture of simple syrup:methylcellulose vehicle. Six batches of each formulation were prepared; three were stored at refrigerated temperature (2º to 8ºC) and three at room temperature (20º to 25ºC). Samples were collected from each batch weekly for 6 weeks, and again at 12 weeks. Samples were analyzed by means of a high-performance liquid chromatographic method, and the concentrations obtained were compared to the theoretical time zero value. Samples were examined for pH, odor, color, and consistency changes. The suspensions also were evaluated for their microbial stability. Sotalol hydrochloride oral liquid suspensions (5 mg/mL) were chemically stable for 12 w


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