Dolutegravir Sodium Film-Coated Tablets (50 mg)
Healthy Inc is a specialized global supplier and exporter of advanced infectious disease, immunology, and targeted high-containment antiretroviral therapeutics. We provide ultra-high-purity, kinetically stabilized Dolutegravir (as Sodium) Film-Coated Tablets (50 mg), manufactured in WHO–GMP certified, high-containment (OEB 4) oral solid dosage facilities. This “Next-Generation Integrase Strand Transfer Inhibitor (INSTI)” is a massive-volume, highly strategic export to infectious disease networks, mega-NGO procurement boards (PEPFAR, Global Fund), public health clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, undisputed first-line intervention for the comprehensive treatment of HIV-1 infection.
Product Overview
This highly advanced formulation operates as a devastating, terminal blockade against the HIV virus. Instead of trying to stop the virus from building its DNA, Dolutegravir attacks the absolute final stage of the infection process: it physically paralyzes the enzyme the virus uses to permanently stitch its DNA into the human chromosome.
The “Integrase Strand Transfer Inhibitor (INSTI)” Specialist:
- Mechanism 1 (The Integrase Paralyzer): Once the HIV virus transcribes its RNA into DNA, it uses an enzyme called Integrase to transport that viral DNA into the human cell nucleus and integrate it into the host’s genetic code. Dolutegravir binds with immense affinity to the active site of this Integrase enzyme, specifically blocking the “strand transfer” step. If the viral DNA cannot integrate into the human genome, the infection cycle is permanently aborted, and the virus dies.
- Mechanism 2 (The High Genetic Barrier to Resistance): Older ARVs (like Efavirenz or Nevirapine) required only a single viral mutation to fail completely. Dolutegravir’s molecular structure allows it to bind so tightly and adjust so flexibly within the integrase pocket that the virus must make multiple, catastrophic mutations to survive it. This “high genetic barrier” makes it the ultimate anchor for long-term, lifelong HIV suppression.
- Mechanism 3 (The Clean CNS Profile): Because it acts on a viral enzyme that does not exist in the human body, Dolutegravir is exceptionally well-tolerated. It completely eliminates the severe psychiatric toxicity, vivid nightmares, and debilitating depression associated with the older Efavirenz-based regimens, massively driving up patient adherence.
Product Composition & Strength
We supply this product as a Precision-Blended, Polymorphically Stabilized Microdose Tablet, packed exclusively in highly secure, moisture-resistant heavy-gauge HDPE bottles or Alu-Alu blister strips to ensure the absolute chemical survival of the Dolutegravir Sodium salt.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Dolutegravir (as Sodium) USP/Ph.Eur. | 50 mg | The Global INSTI Anchor: The definitive therapeutic payload required to force immediate, systemic viral suppression and maintain an undetectable viral load. |
| Excipients | D-Mannitol / Microcrystalline Cellulose / Sodium Starch Glycolate / Povidone K-30 / Sodium Stearyl Fumarate / Premium Polymeric Film | Diluent / Binder / Superdisintegrant / Glidant / Heavy Film-Coating (Engineered specifically utilizing strict low-moisture granulation to prevent the active Dolutegravir Sodium from undergoing polymorphic shifts during compression, guaranteeing absolute pharmacokinetic bioequivalence) |
*Pack Sizes: Heavy-Gauge HDPE Bottles of 30 or 10×10 Alu-Alu Blisters (Optimized specifically for massive NGO distribution and chronic daily dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Infectious Disease Distributors, and NGO Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antivirals/ARVs) |
| CAS Number | 1051375-16-6 (Dolutegravir Sodium) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | Heavy-Gauge HDPE Bottles or Alu-Alu Blisters (STRICTLY MANDATORY). Ensures the physical integrity of the tablet and protects the highly potent ARV formulation from degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Moisture and Direct Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- OEB 4 Containment & Polymorphic Control (CRITICAL COMPLIANCE): Dolutegravir is highly potent; exposure to airborne API dust on the factory floor is a severe occupational hazard. We manufacture this drug in dedicated, negative-pressure High-Containment Suites (OEB 4). Furthermore, Dolutegravir Sodium exists in several crystalline forms. If a generic manufacturer uses excess heat or moisture during granulation, the API can shift into an insoluble polymorph, rendering the pill completely useless. Our advanced analytical profiling (XRD/DSC) guarantees 100% polymorphic purity and flawless clinical efficacy.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized lifelong management of HIV-1:
- HIV-1 Treatment (Treatment-Naïve & Experienced): Used in combination with other antiretroviral agents (typically an NRTI backbone like Tenofovir/Lamivudine) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 20 kg.
- Post-Exposure Prophylaxis (PEP): Frequently utilized as the preferred third agent in 28-day emergency regimens following a high-risk occupational or non-occupational exposure to HIV.
Dosage & Administration
Recommended Dosage (Strictly as per Infectious Disease Guidelines):
- Standard Adult Dosing (Treatment-Naïve): 50 mg taken orally once daily.
- INSTI-Experienced or Suspected Resistance: 50 mg taken orally twice daily (BID).
- Administration: Can be taken with or without food. Taking it with a high-fat meal actually increases absorption, unlike older ARVs.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- The Polyvalent Cation Interaction (EFFICACY FAILURE): CRITICAL WARNING: Dolutegravir violently chelates (binds) with polyvalent cations found in antacids (magnesium/aluminum), calcium supplements, iron supplements, and multivitamins. If taken together, the Dolutegravir is trapped in the gut and excreted, leading to catastrophic viral breakthrough. DTG must be taken 2 hours before or 6 hours after any of these supplements.
- Severe Hypersensitivity Reactions: Can cause life-threatening hypersensitivity reactions characterized by severe rash, constitutional findings (fever, extreme fatigue), and severe organ dysfunction, including hepatotoxicity. Therapy must be discontinued immediately if a severe rash develops.
- Hepatotoxicity in HBV/HCV Co-Infection: Patients co-infected with Hepatitis B or C are at a highly elevated risk of suffering severe liver enzyme elevations (AST/ALT spikes) upon initiating Dolutegravir.
- Weight Gain Paradigm: While lacking the CNS toxicity of older drugs, modern INSTIs like Dolutegravir have been strongly linked to significant, sometimes severe, weight gain and metabolic shifting in patients initiating therapy.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Mega-NGO Outbreak Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antiretrovirals, Integrase Inhibitors, and Polymorphically-Stabilized Formulations. Whether you are looking for a reliable Government Tender Supplier for national WHO-transition programs in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.