Description
Lopinavir & Ritonavir Tablets
Healthy Inc is a specialized global supplier and exporter of advanced Second-Line Antiretrovirals (ARVs). We provide high-stability Lopinavir & Ritonavir Tablets (Heat-Stable), sourced from WHO–GMP certified solid dosage facilities. This “Boosted Protease Inhibitor” is a top export to National AIDS Control Programs, PEPFAR/Global Fund initiatives, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the cornerstone therapy for HIV-1 patients who have developed resistance to first-line regimens.
Product Overview
This formulation contains a co-formulation of Lopinavir (the active protease inhibitor) and Ritonavir (the pharmacokinetic enhancer).
The “Booster” Specialist:
- Mechanism (Lopinavir): It binds to the active site of the HIV-1 Protease enzyme, preventing the cleavage of viral polyprotein precursors into mature, functional proteins. This results in the production of immature, non-infectious viral particles.
- Mechanism (Ritonavir – The Booster): Lopinavir is rapidly metabolized by liver enzymes (CYP3A4). Ritonavir is a potent inhibitor of CYP3A4. By “sacrificing” itself to block this enzyme, Ritonavir boosts the plasma concentration of Lopinavir by >100-fold, maintaining therapeutic levels for a full 12-24 hours.
- Heat Stability (The Upgrade): Unlike the older soft-gel capsules which required refrigeration (Cold Chain), our Tablets are manufactured using Hot Melt Extrusion (HME) technology. They remain stable in tropical climates (Zone IVb) without refrigeration, making them ideal for distribution in Africa.
Product Composition & Strength
We supply this product as Film Coated Tablets (typically Yellow, Oval). The proprietary matrix ensures high bioavailability of poorly soluble Lopinavir.
| Active Ingredient | Strength (Standard) | Therapeutic Role | |
|---|---|---|---|
| Lopinavir USP/BP | 200 mg | HIV-1 Protease Inhibitor | |
| Ritonavir USP/BP | 50 mg | Pharmacokinetic Booster | |
| (Pediatric Variant) | 100 mg Lopinavir + 25 mg Ritonavir | Pediatric HIV Management | |
| Excipients | Q.S. | Copovidone / Sorbitan Monolaurate / Silica | Solubility Enhancers |
*Pack Sizes: HDPE Bottles of 120 tablets (Standard Month Supply), 60s, or Blister packs for hospital use.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Distributors.
| HS Code | 3004.90.99 (Other Medicaments) |
| Dosage Form | Tablet (Heat Stable / Melt Extrusion) |
| Packaging | HDPE Bottle with Desiccant (Moisture Protection) |
| Storage | Store below 30°C. No Refrigeration Required. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Amorphous Solid Dispersion: Lopinavir is practically insoluble in water. We use Hot Melt Extrusion (HME) technology to disperse the drug in a polymer matrix at the molecular level (amorphous state). This ensures the tablet dissolves rapidly in the gut, mimicking the bioavailability of the original liquid-filled capsule without the temperature instability.
- Hardness: The tablets are compressed to high hardness to withstand transport vibration but are engineered to disintegrate rapidly once ingested.
Therapeutic Indications (Human Use)
Indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents:
- Second-Line Therapy: The WHO preferred option for adults and children who have failed first-line NNRTI-based regimens (e.g., Efavirenz failure).
- Pediatric HIV: A core component of pediatric ART formulations due to high efficacy.
Dosage & Administration
Recommended Dosage (Strictly as per HIV Specialist):
- Route: Oral.
- Adults: Two tablets (Total 400/100 mg) twice daily OR Four tablets (800/200 mg) once daily (in specific patients).
- Children: Dosed by weight/surface area using the 100/25 mg tablet.
- Administration: Tablets must be swallowed whole and not chewed, broken, or crushed (bitter taste and altered release). Can be taken with or without food.
Safety Warnings:
- Drug Interactions (CRITICAL): Ritonavir is a potent CYP3A4 inhibitor. Contraindicated with drugs cleared by this pathway (e.g., Midazolam, Ergotamine, Simvastatin, Rifampicin) as it can cause life-threatening toxicity.
- Pancreatitis: Marked triglyceride elevation can cause pancreatitis.
- Hepatotoxicity: Monitor liver enzymes, especially in patients with Hepatitis B or C coinfection.
- Cardiac Effects: Can prolong PR interval (caution in heart block).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for OSD (Oral Solid Dosage) forms, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.
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