In the pharmaceutical industry, Artesunate is an artemisinin derivative and a critical blood schizontocidal agent. As a pharmacist and manufacturer, I must differentiate between its two primary clinical uses: Oral treatment for uncomplicated malaria and Parenteral treatment for severe malaria.
At your WHO-GMP facility in Mumbai, you likely manufacture the 50 mg or 100 mg tablets, which are governed by strict weight-based dosing protocols.
Oral Dosage (Uncomplicated Malaria)
For an adult (typically defined as weighing 50 kg or more), Artesunate is rarely used alone; it is almost always part of an Artemisinin-based Combination Therapy (ACT) to prevent resistance.
| Day | No. of Tablets (50 mg) | No. of Tablets (100 mg) | Total Daily Dose |
| Day 1 | 4 Tablets | 2 Tablets | 200 mg |
| Day 2 | 4 Tablets | 2 Tablets | 200 mg |
| Day 3 | 4 Tablets | 2 Tablets | 200 mg |
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Standard Rule: The adult dose is 4 mg/kg of body weight, taken once daily for 3 consecutive days.
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Combination Requirement: This must be taken alongside a partner drug (like Sulfadoxine/Pyrimethamine or Mefloquine) as per the National Anti-Malaria Drug Policy.
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Parenteral Transition (Severe Malaria)
If the patient was initially treated with injections for severe malaria, the switch to oral tablets happens once they can tolerate food and drink.
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The “Step-Down” Protocol: After a minimum of 24 hours of injectable Artesunate, the patient must complete a full 3-day course of an oral ACT.
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Timing: The first oral dose should be taken 8 to 12 hours after the last injection.
Mechanism: Why the 3-Day Rule?
Artesunate is exceptionally fast-acting but has a very short half-life ($<60\text{ minutes}$).
The Quick Kill: It rapidly reduces the parasite biomass in the first 24 hours.
The Clearance: The subsequent doses (Day 2 and 3) ensure that any remaining “dormant” parasites are eliminated as they re-enter the active cycle.
Resistance Prevention: Stopping after 1 or 2 days is the primary cause of treatment failure and drug resistance.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai, here is how to optimize this product for your digital platforms:
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Packaging USP: For adult patients, we manufacture “Adult Blister Packs” containing 12 tablets of 50 mg (or 6 tablets of 100 mg). This ensures the patient has exactly the right amount for a 3-day course, significantly improving compliance.
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Dissolution Profile: As a pharmacist, you know that for oral tablets to be effective against malaria, they must disintegrate rapidly ($<15\text{ minutes}$). Highlighting your advanced compression technology is a major selling point for international health NGOs.
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Dossier Readiness: We provide full CTD/eCTD Dossiers to support your firm in bidding for massive government tenders in Africa and Southeast Asia.
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Stability for Zone IVb: We utilize Alu-Alu blister packaging to protect the sensitive Artesunate molecule from the high heat and humidity of tropical export markets.