In the pharmaceutical industry, Cilostazol 50 mg is a specific phosphodiesterase III (PDE3) inhibitor with potent antiplatelet and vasodilatory properties. As a pharmacist, I view Cilostazol as a unique therapeutic agent because, unlike standard antiplatelets like Aspirin, it actively improves blood flow by dilating the arteries while simultaneously preventing clot formation.
Primary Clinical Uses
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Intermittent Claudication: The primary indication for Cilostazol is the reduction of symptoms of intermittent claudication (leg pain, cramping, or tiredness while walking) in patients with Peripheral Arterial Disease (PAD). It increases the distance patients can walk without pain.
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Secondary Stroke Prevention: In some regions, it is used as an alternative or adjunct for the prevention of ischemic stroke, particularly in patients who cannot tolerate other antiplatelet therapies.
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Percutaneous Coronary Intervention (PCI): Occasionally used off-label to prevent restenosis after stent placement.
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Buerger’s Disease (Thromboangiitis Obliterans): Used to improve circulation in the small and medium-sized arteries of the hands and feet.
Mechanism of Action
Cilostazol works through a dual-action biochemical pathway:
Inhibition of PDE3: By inhibiting the phosphodiesterase III enzyme, Cilostazol increases the levels of cyclic adenosine monophosphate (cAMP) within platelets and blood vessel walls.
Antiplatelet Effect: Higher cAMP levels in platelets prevent them from aggregating (clumping), which reduces the risk of thrombus formation.
Vasodilation: Increased cAMP in the vascular smooth muscle cells leads to relaxation of the arteries (vasodilation), which directly increases blood flow to the limbs.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Cilostazol 50 mg is a specialized cardiovascular product:
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Bioavailability Challenges: Cilostazol is practically insoluble in water. As a WHO-GMP manufacturer, we utilize micronization technology to reduce particle size, ensuring consistent dissolution and optimal absorption.
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Dose Titration: We manufacture both 50 mg and 100 mg strengths. The 50 mg tablet is essential for patients who require a lower dose due to side effects like headaches or for those taking co-medications (like CYP3A4 inhibitors) that increase Cilostazol levels.
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Stability for Export: We utilize Alu-Alu blister packaging to protect the tablets from moisture and light, ensuring a 24-month shelf life for export to Zone IVb regions (Africa, SE Asia, and the Middle East).
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Regulatory Support: Our Mumbai-based facility provides comprehensive CTD/eCTD Dossiers and comparative dissolution data against the innovator (Pletal) to support international registration and B2B trade.