In the pharmaceutical industry, Artemether and Lumefantrine dispersible tablets (standardized at 20 mg / 120 mg) are the specialized pediatric formulation of the gold-standard Artemisinin-based Combination Therapy (ACT). As a pharmacist, I view the “dispersible” delivery system as a life-saving innovation designed to ensure accurate dosing and rapid absorption in infants and children, who are the most vulnerable to malaria.

Primary Clinical Uses

• Pediatric Uncomplicated Malaria: Specifically indicated for the treatment of acute, uncomplicated malaria caused by Plasmodium falciparum in infants and children weighing between 5 kg and 35 kg.

• Chloroquine-Resistant Strains: First-line defense in regions where malaria parasites have developed resistance to older monotherapies.

• Rapid Parasite Clearance: Used to quickly reduce the parasite biomass in the blood to prevent the progression of uncomplicated malaria into life-threatening severe or cerebral malaria.

Mechanism of Action

This combination employs a “dual-speed” parasiticidal effect:

Artemether: A fast-acting component that generates reactive free radicals. These radicals damage the parasite’s proteins and membranes, providing an immediate “knockdown” of the infection.

Lumefantrine: A long-acting component that clears any remaining parasites over several days. Its presence in the blood prevents the infection from returning (recrudescence) after the short-lived Artemether has cleared.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, the dispersible tablet is a technically demanding product that serves a massive public health niche:

• Dispersibility Standards: As a WHO-GMP quality parameter, these tablets must disintegrate in a small amount of water or milk within 1 to 2 minutes to form a smooth suspension, ensuring the child receives the full dose without the risk of choking.

• Taste-Masking Technology: Artemether and Lumefantrine are naturally very bitter. For a manufacturing firm, the use of advanced sweetening and flavoring agents (such as cherry or strawberry) is essential to prevent the child from spitting out the medicine.

• Stabilization for Tropical Climates: Both APIs, particularly Artemether, are sensitive to heat and moisture. We utilize Alu-Alu blister packaging to ensure a 24-month shelf life in Zone IVb environments (hot and humid), common in Africa and Southeast Asia.

• Global Health Tenders: These are high-volume essential medicines for international NGOs, UNICEF, and the Global Fund. Our Mumbai facility is optimized for the high-capacity production and the rigorous CTD/eCTD documentation required for these global contracts.