Description

Didanosine Delayed-Release Capsules

Healthy Inc is a specialized global supplier and exporter of life-saving infectious disease and antiretroviral (ARV) therapeutics. We provide high-purity Didanosine Delayed-Release Capsules (125 mg / 200 mg / 250 mg / 400 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This “Nucleoside Reverse Transcriptase Inhibitor (NRTI)” is a critical, high-volume export to infectious disease hospitals, HIV/AIDS treatment centers, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a vital component in combination antiretroviral therapy (cART) for the management of HIV-1 infection.

Product Overview

This formulation contains Didanosine (also known as ddI or dideoxyinosine), a synthetic purine nucleoside analogue.

The “Reverse Transcriptase” Specialist:

• Mechanism (DNA Chain Termination): Once inside the host cell, Didanosine is phosphorylated by cellular enzymes into its active metabolite, dideoxyadenosine triphosphate (ddATP). This active molecule competitively inhibits the HIV-1 reverse transcriptase enzyme. Because it lacks a 3′-hydroxyl group, once it is incorporated into the growing viral DNA strand, no further nucleotides can be attached. This causes immediate viral DNA chain termination, halting the replication of the HIV virus.
• The Acid-Lability Challenge: Unprotected Didanosine is rapidly degraded and destroyed by gastric acid. This delayed-release capsule contains enteric-coated beadlets that safely carry the drug through the stomach unharmed, releasing the active ingredient only when it reaches the alkaline environment of the small intestine for maximum absorption.
• Strategic ARV Salvage: While newer ARVs are often used first-line today, Didanosine remains a clinically vital option for multi-drug resistant HIV-1 strains or in patients exhibiting severe intolerance to other NRTIs (like Zidovudine or Tenofovir).

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule containing Enteric-Coated (EC) Beadlets, packed strictly in high-density polyethylene (HDPE) bottles with desiccants or moisture-proof Alu-Alu blisters.

*Pack Sizes: 30-Capsule HDPE Bottles with Child-Resistant Closures (standard for monthly ARV dispensing) or 10×10 Alu-Alu Blisters.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and ARV Tender Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Advanced Fluid-Bed Coating: To protect the acid-labile API, we utilize precision fluid-bed technology to coat the active Didanosine beads with a robust enteric polymer. This guarantees the drug bypasses the highly acidic stomach and dissolves precisely in the duodenum.
• Hygroscopic Control: The entire manufacturing and encapsulation process is executed in low-humidity environments (RH <30%). To ensure maximum shelf-life in tropical climates, bottle configurations include specialized silica gel desiccants.

Therapeutic Indications (Human Use)

Indicated for the treatment of HIV-1 infection:

• HIV-1 Infection: Must be used strictly in combination with other antiretroviral agents (never as monotherapy) for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infection in adult and pediatric patients.

Dosage & Administration

Recommended Dosage (Strictly as per Infectious Disease Specialist):

• Administration (CRITICAL TIMING): Must be taken orally on an empty stomach, at least 30 minutes before or 2 hours after eating. Food massively decreases the absorption of Didanosine (by up to 55%).
• Standard Adult Dose (≥60 kg): 400 mg once daily.
• Low Body Weight Adult (<60 kg): 250 mg once daily.
• Renal Impairment: Because Didanosine is eliminated by the kidneys, the dosage must be drastically reduced in patients with a creatinine clearance of <60 mL/min to prevent severe toxicity.
• Swallowing Protocol: Capsules must be swallowed whole. Do not open, crush, or chew, as this will destroy the enteric coating.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Fatal Pancreatitis): Fatal and nonfatal pancreatitis has occurred during therapy with Didanosine. If clinical signs of pancreatitis develop (severe abdominal pain, elevated amylase/lipase), the drug must be suspended immediately.
• BLACK BOX WARNING (Lactic Acidosis & Hepatomegaly): Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination.
• Peripheral Neuropathy: Frequently causes severe, painful peripheral neuropathy (numbness, tingling, pain in hands and feet).
• Ocular Toxicity: Retinal changes and optic neuritis have been reported; periodic dilated retinal examinations are highly recommended.

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 Antiretroviral (ARV) Medicines, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable NGO Tender Supplier for global health 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.