Description

Artesunate and Mefloquine Tablets (AS+MQ)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Artesunate and Mefloquine Tablets in India. This Artemisinin-based Combination Therapy (ACT) is a critical antimalarial formulation recommended by the World Health Organization (WHO) for the treatment of uncomplicated Plasmodium falciparum malaria, particularly in regions with multi-drug resistance (MDR), such as Southeast Asia and the Amazon basin.

We offer Contract Manufacturing (Third Party) services for this high-potency combination. Because Artesunate acts rapidly while Mefloquine has a very long half-life, this combination is extremely effective at preventing recrudescence (return of infection). Our WHO-GMP certified facility in Mumbai utilizes advanced Bilayer Tablet Technology or Co-Blistered Combi-Packs to ensure the chemical stability of both active ingredients. Healthy Inc manages the export logistics, supplying National Malaria Control Programs (NMCP) and NGOs with high-stability formulations.

2. Product Specifications

3. Manufacturing Technology

Ensuring stability in tropical climates is our priority.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Bilayer Technology: To prevent chemical interaction, we often manufacture this as a Bilayer Tablet. One layer contains Artesunate (acid-sensitive) and the other contains Mefloquine. This physical separation ensures that the Artesunate does not degrade into Dihydroartemisinin prematurely.

  • Hydrolysis Protection: Artesunate is highly susceptible to moisture. We process it in Dehumidified Suites (< 30% RH) and use moisture-protective excipients.

  • Taste Masking: Mefloquine is intensely bitter. We use specialized film coatings (Opadry) or sweeteners in pediatric formulations to improve palatability and compliance.

• The Exporter: Healthy Inc

  • High-Barrier Packaging: We exclusively use Alu-Alu Cold Form Blisters for this product. This provides a near-perfect barrier against humidity and light, which is essential for preserving the potency of Artesunate during transport to malaria-endemic regions.

4. Quality Assurance

We adhere to strict Pharmacopoeial and WHO protocols:

• Dissolution: We test the release rate of both drugs. Artesunate must release immediately (>85% in 15 mins) to lower the parasite load, while Mefloquine releases effectively to clear residual parasites.

• Related Substances: We strictly monitor for degradation products like Artemisinin and specific Mefloquine impurities to ensure safety.

• Assay: We confirm the precise content of both actives (90-110%) using validated HPLC methods.

5. Why Use Artesunate + Mefloquine?

It is the drug of choice for resistant malaria strains.

• Mechanism:

  • Artesunate: Rapidly reduces the parasite biomass (kills 99% of parasites within the first 24 hours).

  • Mefloquine: Has a very long half-life (2-3 weeks); it eliminates the remaining parasites (“mop-up” action) to prevent the infection from returning.

• Key Indications:

  • MDR Malaria: Highly effective in areas where Plasmodium falciparum is resistant to other drugs like Chloroquine or SP.

  • Standby Treatment: Often prescribed for travelers to carry in case of emergency malaria symptoms in remote areas.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Artesunate Mefloquine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using stability-enhanced bilayer technology.

• Q: Can this be used for prevention (prophylaxis)?

  A: No. This combination is for treatment only. Mefloquine alone can be used for prevention, but Artesunate should not be used for long-term prophylaxis to prevent resistance.

• Q: Does it cause neuropsychiatric side effects?

  A: Mefloquine has been associated with anxiety, vivid dreams, or dizziness in some patients. It should be used with caution in patients with a history of psychiatric conditions.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Course: Taken once daily for 3 days.

• Dosing by Weight:

  • 5 to <9 kg: 1 tablet (25/55mg) daily.

  • 9 to <18 kg: 2 tablets (25/55mg) daily.

  • 30 kg (Adult): 2 tablets (100/220mg) daily.

• Administration: Take with food or a full glass of water to improve absorption and reduce stomach upset.

9. Side Effects and Precautions

• Common Side Effects: Nausea, vomiting, dizziness, sleep disturbances (vivid dreams), and abdominal pain.

• Neuropsychiatric: Rare but serious risk of anxiety, depression, or hallucinations. Contraindicated in patients with a history of seizures or psychiatric disorders.

• Cardiac: Use with caution in patients with cardiac conduction disorders.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep strictly protected from light and moisture.