Healthy Inc > Blog > Antiretroviral drug export
Posted on:

What is the use of Nevirapine tablet?

In the pharmaceutical industry, Nevirapine is a cornerstone Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI). As a pharmacist and manufacturer, I classify Nevirapine as a “first-generation” antiretroviral. While newer regimens often favor Integrase Inhibitors, Nevirapine remains a critical, cost-effective tool in global health, particularly in preventing mother-to-child transmission and as part of triple-drug FDCs (Fixed-Dose Combinations).

Primary Clinical Uses

  • HIV-1 Infection Management: Used in combination with other antiretrovirals (usually two NRTIs like Lamivudine and Zidovudine) to treat HIV-1. It helps reduce the viral load and increase the CD4+ cell count.

  • Prevention of Mother-to-Child Transmission (PMTCT): This is perhaps its most significant global use. A single dose given to the mother at the onset of labor and to the neonate within 72 hours of birth significantly reduces the risk of HIV transmission during delivery.

  • Chronic Maintenance: It is used for long-term suppression of the virus in patients who are stable on their current regimen.

Mechanism of Action: The “Wrench in the Gears”

Nevirapine acts by directly disabling the machinery the virus uses to replicate.

Direct Binding: Unlike NRTIs (which mimic building blocks), Nevirapine binds directly to the HIV-1 Reverse Transcriptase enzyme.

Allosteric Inhibition: It binds to a site called the “NNRTI pocket,” located near the active site of the enzyme.

Halt of Replication: This binding causes a conformational change in the enzyme, physically blocking its ability to convert viral RNA into DNA. This effectively halts the replication of the virus before it can integrate into the host cell’s DNA.

The Manufacturer’s Perspective: Formulation & Export

From a production and B2B trading standpoint at our WHO-GMP facility, Nevirapine 200 mg involves specific technical and safety protocols:

  • Lead-in Dosing (Titration): As a pharmacist, you know that Nevirapine is associated with a high incidence of skin rashes. Therefore, it is manufactured for a “14-day lead-in period” (200 mg once daily) before increasing to the full maintenance dose (200 mg twice daily). This technical detail is vital for your Product Information Leaflet (PIL).

  • API Stability & Polymorphism: Nevirapine is relatively stable but requires strict monitoring of its crystalline form during the granulation process to ensure consistent dissolution as per BP/USP/IP monographs.

  • Export Packaging: We utilize Alu-Alu or high-barrier PVC/PVDC blister packaging to ensure a 36-month shelf life. This is essential for maintaining efficacy during long-lead shipments to Zone IVb regions.

  • Dossier & Tender Support: This is a high-volume product for international health organizations. Our Mumbai facility provides the eCTD Dossiers and bioequivalence data required for participation in global tenders.

Nevirapine Tablets

Posted on:

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.

Nelfinavir Tablets

Add to cart