What is the use of Zidovudine Tablet?

In the pharmaceutical industry, Zidovudine (AZT) 300 mg is a landmark nucleoside reverse transcriptase inhibitor (NRTI). As a pharmacist and manufacturer, I view this as a cornerstone of antiretroviral therapy (ART). It was the first breakthrough drug approved for the treatment of HIV and remains a vital component of maternal-fetal health protocols.

Primary Clinical Uses

  • HIV-1 Infection: Used in combination with other antiretroviral agents to manage and control HIV infection, reducing the viral load and increasing CD4 cell counts.

  • Prevention of Maternal-Fetal Transmission: Crucial for pregnant women living with HIV to prevent the virus from passing to the baby during pregnancy and childbirth.

  • Post-Exposure Prophylaxis (PEP): Used in emergency situations (like healthcare needle-stick injuries) to prevent HIV infection after potential exposure.

Mechanism of Action: Chain Termination

Zidovudine works by “tricking” the virus during its replication process.

Phosphorylation: Once inside the human cell, Zidovudine is converted by cellular enzymes into its active form, Zidovudine Triphosphate.

Molecular Mimicry: It structurally resembles Thymidine, one of the natural building blocks the HIV virus uses to create its DNA.

Reverse Transcriptase Inhibition: The viral enzyme, Reverse Transcriptase, mistakenly incorporates Zidovudine into the growing viral DNA chain instead of the natural thymidine.

Chain Termination: Because Zidovudine lacks the necessary chemical “hook” (the 3′-OH group) to attach the next building block, the DNA chain is terminated. The virus cannot finish copying its genetic material and fails to replicate.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your WHO-GMP facility in Mumbai, Zidovudine 300 mg is a high-impact global health product:

  • The 300 mg Standard: This is the international therapeutic standard for adults. For your digital platforms, highlighting your ability to produce high-volume Fixed-Dose Combinations (FDCs)—such as Zidovudine + Lamivudine—is a major strategy for securing international NGO contracts.

  • Bone Marrow Suppression Monitoring: As a pharmacist, you know the primary side effect is anemia/neutropenia. Including technical guidance on Hematological Monitoring in your B2B dossiers and product literature builds immense professional trust.

  • Stability & Light Sensitivity: Zidovudine is sensitive to light. At our facility, we utilize Alu-Alu or Amber-colored PVC/PVDC blisters to ensure a 36-month shelf life, which is a requirement for export to Zone IVb regions.

  • Dossier & Tenders: This is a priority molecule for PEPFAR, the Global Fund, and UNAIDS. We provide full CTD/eCTD Dossiers to support your firm in bidding for these massive international supply tenders.

What is Tenofovir Disoproxil Fumarate Tablets 300 mg used for?

In the pharmaceutical industry, Tenofovir Disoproxil Fumarate (TDF) 300 mg is a potent Nucleotide Reverse Transcriptase Inhibitor (NRTI). As a pharmacist and manufacturer, I classify this as a “backbone” therapy for viral management. It is a prodrug that effectively suppresses viral replication, making it a cornerstone of global health initiatives.

Primary Clinical Uses

  • HIV-1 Infection: It is a primary component of Highly Active Antiretroviral Therapy (HAART). It is always used in combination with at least two other antiretroviral medicines to treat adults and pediatric patients (weighing at least 35 kg).

  • Chronic Hepatitis B (HBV): It is a first-line monotherapy for the treatment of chronic hepatitis B in adults. It helps reduce the amount of HBV in the body and improves the condition of the liver.

  • PrEP (Pre-Exposure Prophylaxis): In combination with Emtricitabine, TDF is used by HIV-negative individuals at high risk of infection to prevent the acquisition of HIV.

Mechanism of Action: DNA Chain Termination

Tenofovir works by “tricking” the virus during its replication process.

Intracellular Activation: TDF is a prodrug. Once inside the cell, it is converted by cellular enzymes into its active form, Tenofovir Diphosphate.

Reverse Transcriptase Targeting: This active form competes with the natural substrate (deoxyadenosine 5′-triphosphate) for a spot in the viral DNA chain.

Chain Termination: Because Tenofovir lacks a necessary “hook” (the 3′-OH group) for the next building block to attach to, the viral DNA chain is broken. This prevents the virus from successfully replicating its genetic material.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your WHO-GMP facility in Mumbai, TDF 300 mg is a high-demand “Essential Medicine”:

  • The 300 mg Standard: This is the universal dose for HIV and HBV in adults. On your digital platforms, marketing this as a WHO-Prequalified equivalent is a major strategy for securing international NGO and government contracts.

  • Hygroscopic Nature: TDF is highly hygroscopic (absorbs moisture from the air). As a manufacturer, you know that specialized environmental controls (Low RH) are required during compression. We utilize Alu-Alu blister packaging or HDPE bottles with desiccant caps to ensure a 36-month shelf life in Zone IVb climates.

  • Renal Monitoring USP: As a pharmacist, your Product Information Leaflets (PIL) must emphasize monitoring of Creatinine Clearance and bone mineral density. This clinical accuracy on your website builds immense trust with B2B medical directors.

  • Dossier & Tenders: This molecule is the primary requirement for PEPFAR and Global Fund tenders. Our Mumbai facility provides full CTD/eCTD Dossiers to support your firm in registering this as a reliable generic against the innovator (Viread).

 

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