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The Annals of Pharmacotherapy: Vol. 37, No. 4, pp. 506-509. DOI 10.1345/aph.1C333
© 2003 Harvey Whitney Books Company.
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DRUG STABILITY

Stability of Sotalol in Two Liquid Formulations at Two Temperatures

Milap C Nahata, PharmD

Professor of Pharmacy and Division Chair, College of Pharmacy; Professor of Pediatrics and Internal Medicine, College of Medicine and Public Health, The Ohio State University and Children's Hospital, Columbus, OH

Richard S Morosco

Research Associate, Pharmacy Practice and Administration, College of Pharmacy, The Ohio State University

Reprints: Milap C Nahata PharmD, College of Pharmacy, The Ohio State University, 500 W. 12th Ave., Columbus, OH 43210-1291, FAX 614/292-1335

BACKGROUND: Sotalol is used in certain pediatric patients to treat, suppress, or prevent the recurrence of life-threatening ventricular arrhythmias. However, it is commercially unavailable in a liquid dosage form. The use of an extemporaneously prepared liquid dosage form must be supported by the documentation of the chemical and physical stability of sotalol.

OBJECTIVE: To determine the stability of sotalol hydrochloride extemporaneously prepared from tablets in 2 oral suspensions stored at 2 temperatures.

METHODS: Five bottles contained Ora Plus:Ora Sweet (1:1) and the other 5 bottles had 1% methylcellulose:simple syrup NF (1:9), with a sotalol concentration of 5 mg/mL. Three samples were collected from each bottle at 0, 7, 14, 28, 42, 56, 70, and 91 days and analyzed by a stability-indicating HPLC analytical method (n = 15).

RESULTS: At 4 °C, the mean concentration of sotalol was at least 98.9% of the original concentration in Ora Plus:Ora Sweet suspension and 95.5% of the initial concentration in 1% methylcellulose:simple syrup during storage for 3 months. At 25 °C, the mean concentration of sotalol was >=95.5% of the original concentration in Ora Plus:Ora Sweet suspension and 94.4% of the initial concentration in 1% methylcellulose:simple syrup during storage for 3 months. The pH did not change substantially during the study period. Further, no changes in physical appearance were seen during the study.

CONCLUSIONS: Sotalol hydrochloride can be prepared in either of 2 liquid dosage forms and stored in plastic bottles for 13 weeks at 4 or 25 °C without substantial loss of potency.

Key Words: oral liquid, sotalol, stability

Published Online, March 6, 2003. www.theannals.com, DOI 10.1345/aph.1C333




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