In the pharmaceutical industry, the combination of Lamivudine (150 mg), Zidovudine (300 mg), and Nevirapine (200 mg) is a landmark Triple Fixed-Dose Combination (FDC). As a pharmacist and manufacturer, I classify this as a complete “First-Line ARV Regimen” for the treatment of HIV-1 infection.
This combination was a revolutionary development in global health because it simplified the complex “HAART” (Highly Active Antiretroviral Therapy) from multiple pills a day down to a single tablet taken twice daily, significantly improving patient compliance.
Primary Clinical Use
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Treatment of HIV-1 Infection: It is used to manage advanced HIV infection in adults and adolescents, helping to lower the viral load to “undetectable” levels and allowing the immune system (CD4 cells) to recover.
Triple Mechanism of Action (The Multi-Pronged Attack)
This FDC combines two different classes of antiretrovirals to inhibit the viral replication process at multiple stages:
Lamivudine (150 mg) & Zidovudine (300 mg): These are Nucleoside Reverse Transcriptase Inhibitors (NRTIs). They act as “fake building blocks” (analogs). When the HIV enzyme (Reverse Transcriptase) tries to build viral DNA, it incorporates these instead of real nucleotides, causing DNA chain termination.
Nevirapine (200 mg): This is a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI). Unlike the NRTIs, it does not mimic building blocks. Instead, it binds directly to the Reverse Transcriptase enzyme itself, “jamming” the machinery so it cannot function.
The Manufacturer’s Perspective: Technical & Export Details
Producing this triple combination in a WHO-GMP facility involves high-level pharmaceutical engineering:
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Bilayer Tablet Technology: Because these three APIs have different physical properties and dosages, we often manufacture them as bilayer tablets. This ensures the stability of each component and prevents chemical interactions within the tablet matrix.
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Content Uniformity & Purity: As a firm owner, you know that Nevirapine is highly hydrophobic. We utilize specialized wet granulation techniques to ensure that the 200 mg of Nevirapine is evenly distributed and meets the strict BP/USP/IP dissolution profiles.
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Stability for Global Trade: This FDC is primarily exported to Zone IVb regions (Sub-Saharan Africa and SE Asia). We utilize Alu-Alu blister packaging or HDPE bottles with molecular sieve desiccants to ensure a 24–36 month shelf life in high-heat and high-humidity environments.
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Regulatory & Tenders: This product is a staple for National AIDS Control Programs (NACO) and international tenders (Global Fund). Our Mumbai facility provides the full eCTD Dossiers and Bioequivalence (BE) studies required for these high-volume contracts.