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
相关论文
共 8 条
[1]   SUBCUTANEOUS SUMATRIPTAN FOR TREATMENT OF ACUTE MIGRAINE IN PATIENTS ADMITTED TO THE EMERGENCY DEPARTMENT - A MULTICENTER STUDY [J].
AKPUNONU, BE ;
MUTGI, AB ;
FEDERMAN, DJ ;
VOLINSKY, FG ;
BRICKMAN, K ;
DAVIS, RI ;
GILBERT, C ;
ASGHARNEJAD, M .
ANNALS OF EMERGENCY MEDICINE, 1995, 25 (04) :464-469
[2]  
Cady R K, 1994, Arch Fam Med, V3, P766, DOI 10.1001/archfami.3.9.766
[3]  
NAPPI G, 1994, J NEUROL, V241, P138
[4]   SUMATRIPTAN - A REAPPRAISAL OF ITS PHARMACOLOGY AND THERAPEUTIC EFFICACY IN THE ACUTE TREATMENT OF MIGRAINE AND CLUSTER HEADACHE [J].
PLOSKER, GL ;
MCTAVISH, D .
DRUGS, 1994, 47 (04) :622-651
[5]   ORAL SUMATRIPTAN IN PREVENTING HEADACHE RECURRENCE AFTER TREATMENT OF MIGRAINE ATTACKS WITH SUBCUTANEOUS SUMATRIPTAN [J].
RAPOPORT, AM ;
VISSER, WH ;
CUTLER, NR ;
ALDERTON, CJ ;
PAULSGROVE, LA ;
DAVIS, RL ;
FERRARI, MD .
NEUROLOGY, 1995, 45 (08) :1505-1509
[6]  
REDERICH G, 1995, NEUROLOGY, V45, pS15
[7]   QUALITY-OF-LIFE ASSESSMENT AMONG MIGRAINE PATIENTS TREATED WITH SUMATRIPTAN [J].
SOLOMON, GD ;
SKOBIERANDA, FG ;
GENZEN, JR .
HEADACHE, 1995, 35 (08) :449-454
[8]  
*US PHARM CONV, 1989, US PHARM, P1479