Stability of terbinafine hydrochloride in an extemporaneously prepared oral suspension at 25 and 4 degrees C.
The stability of terbinafine 25 mg/mL (as the hydrochloride salt) in an extemporaneously prepared oral suspension at 25 and 4 degrees C was studied. Twenty 250-mg terbinafine tablets were crushed to a fine powder and diluted to a concentration of 25 mg/mL with sweetened vehicle. The suspension was stored in amber polyethylene prescription bottles at 25 or 4 degrees C. Samples were taken on days 0, 7, 14, 28, 42, 56, 70, and 91 for duplicate analysis of terbinafine content by high-performance liquid chromatography and to observe any changes in color and odor; pH was measured as well. Through the initial 42 days, the mean concentration of terbinafine in the samples stored at both temperatures was >93% of the initial concentration; by day 56, the mean concentration was <88%. No appreciable changes in color or odor were observed during the study period. The apparent pH of the suspension decreased slightly over the 91 days, from an initial 5.6 to 5.5. Terbinafine 25 mg/mL (as the hydrochloride salt) in an extemporaneously prepared oral suspension was stable for up to 42 days in polyethylene prescription bottles at 25 and 4 degrees C.
College of Pharmacy, The Ohio State University, Wexner Institute for Pediatric Research, Children's Hospital, Columbus 43210, USA.
S M
SM
Abdel-Rahman
M C
MC
Nahata
D000284:Administration, Oral; D000935:Antifungal Agents / Q000008:administration & dosage / Q000737:chemistry*; D004339:Drug Compounding; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D009281:Naphthalenes / Q000008:administration & dosage / Q000737:chemistry*; D013535:Suspensions; D013696:Temperature; D000077291:Terbinafine
D000935:Antifungal Agents; D009281:Naphthalenes; D013535:Suspensions; D000077291:Terbinafine