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What is Lopinavir 200mg Ritonavir 50mg Tablet?

In the pharmaceutical industry, the combination of Lopinavir (200 mg) and Ritonavir (50 mg) is a potent Fixed-Dose Combination (FDC) belonging to the Protease Inhibitor (PI) class. As a pharmacist and manufacturer, I view this as a “booster” formulation: Ritonavir is not included here for its own antiviral effect, but rather as a pharmacological “helper” to ensure Lopinavir reaches therapeutic levels in the blood.

Primary Clinical Use

  • HIV-1 Infection: It is indicated for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older). It is typically used as part of a multi-drug antiretroviral regimen to control the viral load and prevent the progression of the disease.

Mechanism of Action: The “Booster” Effect

This combination works through a unique synergistic relationship:

Lopinavir (The Active Antiviral): It is the primary protease inhibitor. It binds to the active site of the HIV protease enzyme, preventing it from cleaving long viral polyproteins into the smaller, functional proteins required to assemble a mature, infectious virus.

Ritonavir (The Booster): At this 50 mg dose, Ritonavir acts as a potent inhibitor of the CYP3A4 enzyme in the liver. Since CYP3A4 is the enzyme responsible for breaking down Lopinavir, Ritonavir “blocks” this degradation.

The Synergy: By inhibiting the metabolism of Lopinavir, Ritonavir significantly increases (boosts) Lopinavir’s plasma concentrations and half-life, allowing for effective 12-hour dosing.

The Manufacturer’s Perspective: Technical & Export

Producing Lopinavir/Ritonavir in a WHO-GMP facility involves high-level pharmaceutical engineering:

  • Amorphous Solid Dispersion (ASD): Both Lopinavir and Ritonavir have very poor water solubility (BCS Class IV). At our facility, we utilize Melt-Extrusion Technology or spray-drying to create a solid dispersion. This ensures the drugs dissolve properly in the patient’s GI tract for consistent absorption.

  • Heat Stability: Earlier versions of this drug required refrigeration. Modern formulations produced in Mumbai use specialized polymers that make the tablets heat-stable, which is a critical selling point for export to Zone IVb regions (Africa and Southeast Asia).

  • Packaging & Shelf Life: These tablets are sensitive to moisture. We utilize high-density polyethylene (HDPE) bottles with induction sealing and desiccants or Alu-Alu blister packaging to ensure a 24–36 month shelf life.

  • B2B & Public Health Tenders: This is a staple for international health organizations. Our facility provides the necessary eCTD Dossiers and bioequivalence data against the innovator (Kaletra) to support your firm’s participation in global tenders.

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