Compounding and Stability Study of Dipyridamole and Clopidogrel Pediatric Oral Suspensions.

Q4 Medicine
Lucile Dho, Said Ait Taleb, Lyna Kireche, Pascal Rathelot, Nicolas Primas, Christophe Jean, Patrice Vanelle, Arnaud Venet, Christophe Curti
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引用次数: 0

Abstract

Dipyridamole and clopidogrel are two antiplatelet agents that can be prescribed off-label in pediatric practice. As commercially available drugs are unavailable, pediatric formulations must be compounded. Both stability-indicating HPLC dosing assays and microbiological methods were validated and described. Stabilities of dipyridamole and clopidogrel in Syrspend® pH4 were studied. The stability study of clopidogrel involved two complementary HPLC methods (RP-HPLC and chiral HPLC). Oral suspension of 10 mg.mL-1 dipyridamole is stable for 3 months at +2/+8°C before opening, 1.5 month at +2/+8°C after opening, and 15 days at 25°C/60% RH. Oral suspension of 5 mg.mL-1 clopidogrel bisulfate is stable only for 1 month at +2/+8°C before or after opening and for 7 days at 25°C/60% RH.

双嘧达莫、氯吡格雷小儿口服混悬液的配制及稳定性研究。
双嘧达莫和氯吡格雷是两种抗血小板药物,可在儿科实践中开说明书外处方。由于市售药物不可用,儿科配方必须复合。验证并描述了稳定性指示的HPLC给药法和微生物法。研究了双嘧达莫和氯吡格雷在syspend®pH4中的稳定性。氯吡格雷的稳定性研究采用反相高效液相色谱法和手性高效液相色谱法进行。口服10 mg.mL-1双嘧达莫在开瓶前+2/+8°C条件下稳定3个月,开瓶后+2/+8°C条件下稳定1.5个月,25°C/60% RH条件下稳定15天。5mg . ml -1硫酸氯吡格雷口服混悬液在开瓶前后+2/+8°C条件下稳定1个月,在25°C/60% RH条件下稳定7天。
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来源期刊
CiteScore
0.40
自引率
0.00%
发文量
62
期刊介绍: The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly, scientific and professional journal emphasizing quality pharmaceutical compounding. IJPC is the only publication that covers pharmaceutical compounding topics relevant and necessary to empower pharmacists to meet the needs of today"s patients. No other publication features hands-on, how-to compounding techniques or the information that contemporary pharmacists need to provide individualized care.
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