Healthy Inc > Blog > Artesunate Amodiaquine FDC
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What is the use of artesunate tablet?

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

  • Uncomplicated Malaria: Indicated for the treatment of acute, uncomplicated malaria caused by Plasmodium falciparum.

  • 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.

  • 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.

  • 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:

  • 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.

  • 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.

  • 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.

  • 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.

Artesunate Tablets

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What is the use of amodiaquine hydrochloride?

In the pharmaceutical industry, Amodiaquine Hydrochloride is a 4-aminoquinoline derivative that serves as a potent antimalarial agent. As a pharmacist, I characterize Amodiaquine as a critical fast-acting blood schizontocide, particularly indispensable in regions where there is established resistance to older molecules like Chloroquine.

Primary Clinical Uses

  • Treatment of Plasmodium falciparum: It is highly effective against the asexual erythrocytic stages of P. falciparum.

  • ACT Combination Therapy: In modern medicine, Amodiaquine is rarely used as a monotherapy. It is most commonly used in Artemisinin-based Combination Therapy (ACT), specifically as Artesunate + Amodiaquine (AS+AQ), which is a WHO-recommended first-line treatment for uncomplicated malaria.

  • Seasonal Malaria Chemoprevention (SMC): Used in combination with Sulfadoxine-Pyrimethamine (SP) for the intermittent administration of full treatment courses during the malaria season to prevent illness in children.

    Mechanism of Action

Amodiaquine acts primarily by inhibiting the polymerization of hemozoin. When the malaria parasite digests the host’s hemoglobin, it releases toxic free heme. Amodiaquine enters the parasite’s food vacuole and prevents the detoxification of this heme into non-toxic hemozoin crystals. The resulting accumulation of free heme is toxic to the parasite, leading to its rapid destruction.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Amodiaquine is a high-priority molecule for public health tenders and international B2B supply:

  • Fixed-Dose Combination (FDC): The primary manufacturing challenge is creating stable FDCs with Artesunate. Since Artesunate is sensitive to moisture, we utilize specialized bilayer tablet technology or advanced granulation techniques to ensure both APIs remain stable.

  • Standardization: We ensure the API meets BP/USP/IP specifications, with a focus on controlling the impurity profile to minimize the risk of rare but serious side effects like agranulocytosis or hepatotoxicity.

  • Global Export Niche: Amodiaquine is a staple for the African and Southeast Asian markets. As a WHO-GMP manufacturer, our facility in Mumbai is optimized for high-volume production for NGO and government tenders (e.g., Global Fund, USAID).

  • Regulatory Readiness: We provide the CTD/eCTD Dossiers and stability data required for registration in malaria-endemic zones, ensuring the product maintains its potency in Zone IVb (hot and humid) conditions.

Amodiaquine Tablets

 

Posted on:

What is the use of amodiaquine hydrochloride?

In the pharmaceutical industry, Amodiaquine Hydrochloride is a 4-aminoquinoline derivative that serves as a potent antimalarial agent. As a pharmacist, I characterize Amodiaquine as a critical fast-acting blood schizontocide, particularly indispensable in regions where there is established resistance to older molecules like Chloroquine.

Primary Clinical Uses

  • Treatment of Plasmodium falciparum: It is highly effective against the asexual erythrocytic stages of P. falciparum.

  • ACT Combination Therapy: In modern medicine, Amodiaquine is rarely used as a monotherapy. It is most commonly used in Artemisinin-based Combination Therapy (ACT), specifically as Artesunate + Amodiaquine (AS+AQ), which is a WHO-recommended first-line treatment for uncomplicated malaria.

  • Seasonal Malaria Chemoprevention (SMC): Used in combination with Sulfadoxine-Pyrimethamine (SP) for the intermittent administration of full treatment courses during the malaria season to prevent illness in children.

Mechanism of Action

Amodiaquine acts primarily by inhibiting the polymerization of hemozoin. When the malaria parasite digests the host’s hemoglobin, it releases toxic free heme. Amodiaquine enters the parasite’s food vacuole and prevents the detoxification of this heme into non-toxic hemozoin crystals. The resulting accumulation of free heme is toxic to the parasite, leading to its rapid destruction.

The Manufacturer’s Perspective: Formulation & Export

From a manufacturing and global trade standpoint, Amodiaquine is a high-priority molecule for public health tenders and international B2B supply:

  • Fixed-Dose Combination (FDC): The primary manufacturing challenge is creating stable FDCs with Artesunate. Since Artesunate is sensitive to moisture, we utilize specialized bilayer tablet technology or advanced granulation techniques to ensure both APIs remain stable.

  • Standardization: We ensure the API meets BP/USP/IP specifications, with a focus on controlling the impurity profile to minimize the risk of rare but serious side effects like agranulocytosis or hepatotoxicity.

  • Global Export Niche: Amodiaquine is a staple for the African and Southeast Asian markets. As a WHO-GMP manufacturer, our facility in Mumbai is optimized for high-volume production for NGO and government tenders (e.g., Global Fund, USAID).

  • Regulatory Readiness: We provide the CTD/eCTD Dossiers and stability data required for registration in malaria-endemic zones, ensuring the product maintains its potency in Zone IVb (hot and humid) conditions.

Amodiaquine Tablets

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