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Compounding and Stability Study of Dipyridamole and Clopidogrel Pediatric Oral Suspensions
Lucile Dho1, Said Ait Taleb1, Lyna Kireche1
1Service Central de la Qualité et de l'Information Pharmaceutiques (SCQIP), Pharmacy Department, Assistance Publique - Hôpitaux de Marseille (AP-HM), Marseille, France.
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.
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