Compounding and Stability Study of Dipyridamole and Clopidogrel Pediatric Oral Suspensions

Author(s):  Dho Lucile, Taleb Said Ait, Kireche Lyna, Rathelot Pascal, Primas Nicolas, Jean Christophe, Vanelle Patrice, Venet Arnaud, Curti Christophe

Issue:  Mar/Apr 2026 - Volume 30, Number 2
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Note:  Electronic version includes supplemental material.

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.

Related Keywords: Dipyridamole, Clopidogrel, Compounding, Quality control

Related Categories: PEDIATRICS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, CARDIOLOGY

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