Stability of sumatriptan succinate in extemporaneously prepared oral liquids

被引:5
|
作者
Fish, DN
Beall, HD
Goodwin, SD
Fox, JL
机构
[1] UNIV COLORADO,HLTH SCI CTR,SCH PHARM,DEPT PHARMACEUT SCI,DENVER,CO 80262
[2] GLAXO WELLCOME INC,HIV HERPES PROGRAM DEV,RES TRIANGLE PK,NC 27709
[3] GLAXO WELLCOME INC,CLIN APPLICAT RES,RES TRIANGLE PK,NC 27709
关键词
central nervous system drugs; compounding; concentration; contamination; incompatibilities; stability; storage; sumatriptan succinate; suspensions; sweetening agents; syrups; vehicles;
D O I
10.1093/ajhp/54.14.1619
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The stability of sumatriptan succinate in extemporaneously prepared oral liquids was studied. Suspensions of sumatriptan (as the succinate salt) in Ora-Sweet, Ora-Sweet SF, and Syrpalta syrups (Paddock Laboratories and Humco Laboratory) were extemporaneously compounded to produce a sumatriptan concentration of 5 mg/mL. Each suspension was prepared in triplicate. The suspensions were stored at 4 degrees C in amber glass bottles for 60 days. Two 1-mt samples were removed from each bottle initially and on days 2, 7, 14, 21, 28, 35, and 60. Sumatriptan concentrations were determined by high-performance liquid chromatography. The samples also underwent visual inspection and microbial testing. The mean concentration of sumatriptan in all suspensions remained above 90% of the initial concentration for up to 21 days. By day 28, the sumatriptan concentration of all suspensions had decreased to less than 90% of the initial concentration. None of the suspensions had microbial growth up to day 28, and there were no visible changes in the suspensions throughout the study period. Sumatriptan 5 mg/mL (as the succinate salt) in three oral suspensions was stable for up to 21 days when stored without light at 4 degrees C.
引用
收藏
页码:1619 / 1622
页数:4
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