In the pharmaceutical industry, the combination of Clopidogrel (75 mg) and Aspirin (75 mg) is a cornerstone of Dual Antiplatelet Therapy (DAPT). As a pharmacist, I view this fixed-dose combination (FDC) as a strategic clinical tool that provides synergistic protection by inhibiting two distinct pathways of platelet activation.
Primary Clinical Uses
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Acute Coronary Syndrome (ACS): Indicated for the reduction of atherothrombotic events in patients with unstable angina or those who have recently suffered a myocardial infarction (heart attack).
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Post-Stent Implantation: A critical requirement after Percutaneous Coronary Intervention (PCI). It prevents stent thrombosis, a life-threatening complication where a clot forms on the newly placed metal or drug-eluting stent.
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Ischemic Stroke & TIA: Used to prevent secondary occurrences in patients who have experienced a minor ischemic stroke or a Transient Ischemic Attack (TIA).
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Peripheral Arterial Disease (PAD): Helps manage patients with established PAD to reduce the risk of major adverse cardiovascular events (MACE).
Mechanism of Action: Dual Pathway Inhibition
This FDC targets platelet aggregation from two different angles:
Aspirin (75 mg): Irreversibly inhibits the COX-1 enzyme, which blocks the synthesis of Thromboxane $A_2$ ($TXA_2$), a powerful promoter of platelet aggregation.
Clopidogrel (75 mg): A prodrug that, once metabolized by the liver (primarily via CYP2C19), irreversibly blocks the $P2Y_{12}$ ADP receptor on the platelet surface. This prevents the activation of the GPIIb/IIIa receptor complex, the final common pathway for platelet cross-linking.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing standpoint, this combination is technically demanding due to the chemical characteristics of the APIs:
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Bilayer Tablet Technology: Aspirin is prone to hydrolysis and can be incompatible with Clopidogrel Bisulphate if mixed in a single-layer matrix. As a WHO-GMP manufacturer, we often utilize bilayer compression to physically separate the two components, ensuring maximum stability.
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Enteric Coating: To minimize gastric mucosal irritation—a common side effect of Aspirin—we apply an enteric coating to the Aspirin component, ensuring it bypasses the stomach and dissolves in the small intestine.
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Stability for Global Trade: Clopidogrel is highly hygroscopic. We prioritize Alu-Alu blister packaging to ensure a stable 24-month shelf life, even in Zone IVb (hot and humid) climates like Africa and Southeast Asia.
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Regulatory Support: Our Mumbai-based hub provides comprehensive CTD/eCTD Dossiers and comparative dissolution studies to assist international B2B partners in rapid product registration.