In the pharmaceutical industry, Artesunate tablets (commonly 50 mg, 100 mg, or 200 mg) are a semi-synthetic derivative of artemisinin. As a pharmacist, I view Artesunate as one of the most powerful and fast-acting antimalarial agents available, serving as the cornerstone of modern malaria therapy to prevent the progression of the disease to severe or fatal stages.
Primary Clinical Uses
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Uncomplicated Malaria: Indicated for the treatment of acute, uncomplicated malaria caused by Plasmodium falciparum.
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ACT Combination Therapy: Following WHO guidelines, Artesunate is almost always used in Artemisinin-based Combination Therapy (ACT). It is paired with longer-acting partner drugs (like Amodiaquine, Mefloquine, or Sulfadoxine-Pyrimethamine) to ensure a complete cure and prevent resistance.
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Step-down Therapy: Used as an oral follow-up treatment after an initial course of parenteral (injectable) artesunate for severe malaria, once the patient can tolerate oral medication.
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Chloroquine-Resistant Malaria: Effective in regions where the parasite has developed high levels of resistance to traditional antimalarials.
Mechanism of Action
Artesunate is a “prodrug” that is rapidly converted into its active metabolite, dihydroartemisinin (DHA). It acts by reacting with the iron in the parasite’s heme (from digested hemoglobin) to create reactive free radicals. These radicals cause extensive damage to the parasite’s proteins and membranes, specifically targeting the asexual erythrocytic stages, leading to a rapid reduction in parasite biomass.
The Manufacturer’s Perspective: Formulation & Export
From a manufacturing and global trade standpoint, Artesunate is a high-priority, technically sensitive molecule:
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Hydrolytic Stability: Artesunate is highly sensitive to moisture and can easily degrade into DHA in the presence of humidity. As a WHO-GMP manufacturer, we utilize strictly controlled, low-humidity environments and Alu-Alu blister packaging to ensure product stability for 24 months.
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Fixed-Dose Combination (FDC) Expertise: We specialize in the complex formulation of Artesunate with partner drugs, ensuring that each API remains stable and bioavailable within a single tablet matrix.
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Global Health Tenders: Artesunate is a staple for international NGOs, UNICEF, and the Global Fund. Our Mumbai facility is optimized for the high-volume production and the rigorous CTD/eCTD documentation required for these global contracts.
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Quality Assurance: Each batch is tested against BP/USP/IP standards to ensure precise potency, which is critical in preventing the emergence of drug-resistant malaria strains.