Description

Glyceryl Trinitrate Tablets (2.6mg / 6.4mg / 0.5mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Glyceryl Trinitrate (GTN) Tablets in India. Also known as Nitroglycerin, this drug is the most widely used Nitrate Vasodilator for the management of Angina Pectoris (chest pain caused by reduced blood flow to the heart).

We offer Contract Manufacturing (Third Party) services for two distinct formulations:

1. Sublingual Tablets (0.5mg): For rapid relief of an acute angina attack.

2. Sustained Release (SR) Tablets (2.6mg / 6.4mg): For the long-term prevention of angina attacks.

Handling Nitroglycerin requires extreme safety protocols as the raw material is volatile and explosive. Our WHO-GMP certified facility in Mumbai utilizes specialized explosion-proof blending suites and “Cold Process” manufacturing to ensure safety and potency. Healthy Inc manages the complex export logistics, supplying cardiology centers and pharmacy chains across the UK, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Handling a volatile drug requires expert engineering.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Stabilization: GTN is a volatile liquid adsorbed onto lactose. It tends to evaporate or “migrate” into plastic. We use Glass Bottles or high-barrier Alu-Alu Blisters to lock the drug inside and prevent potency loss.

  • Sustained Release Matrix: For the 2.6mg/6.4mg tablets, we use a hydrophilic matrix system (HPMC) that swells in the stomach, releasing the drug slowly over 6-8 hours to provide round-the-clock protection against chest pain.

  • Safety: All manufacturing is conducted in Flame-Proof Zones with non-sparking equipment to eliminate the risk of explosion during the processing of the raw material.

• The Exporter: Healthy Inc

  • Temperature Control: We ensure the product is stored and shipped under controlled temperatures (< 25°C) because heat significantly accelerates the degradation of Nitroglycerin.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • Sublingual: Disintegrates in < 2 minutes for instant effect.

  • Sustained Release: Tested at 1h, 4h, and 8h intervals to ensure steady release.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Content Uniformity: Critical for the 0.5mg dose to ensure the patient gets the exact amount needed to stop a heart attack.

5. Why Use Glyceryl Trinitrate?

It opens the blood vessels to feed the heart.

• Mechanism: The body converts Nitroglycerin into Nitric Oxide (NO). NO activates the enzyme guanylyl cyclase, increasing cGMP levels, which causes the smooth muscles of the blood vessels to relax.

• Venodilation: Its primary effect is dilating the veins (reducing preload), which means less blood returns to the heart, reducing the heart’s workload and oxygen demand.

• Coronary Dilation: It also dilates the coronary arteries, improving blood supply to the heart muscle.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Glyceryl Trinitrate Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Can I swallow the 0.5mg tablet?

  A: NO. The 0.5mg tablet must be placed under the tongue (Sublingual). If swallowed, the liver destroys the drug before it works. (Note: The 2.6mg/6.4mg SR tablets are meant to be swallowed).

• Q: Why do I get a headache?

  A: The “Nitrate Headache” is very common. It happens because the drug dilates blood vessels in the head too. It usually improves with continued use.

• Q: Can I take Sildenafil (Viagra) with it?

  A: ABSOLUTELY NOT. Combining Nitroglycerin with ED drugs (Sildenafil, Tadalafil) can cause a fatal drop in blood pressure.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Acute Angina: Dissolve one 0.5mg tablet under the tongue. Repeat every 5 minutes (max 3 doses). If pain persists, call an ambulance.

• Prevention (Chronic): 2.6mg or 6.4mg SR tablet swallowed whole, 2 to 3 times daily.

• Nitrate-Free Interval: To prevent tolerance (where the drug stops working), patients on chronic therapy must have a 10-12 hour “nitrate-free” period every day (usually at night).

9. Side Effects and Precautions

• Hypotension: Dizziness, lightheadedness, or fainting (syncope). Sit down when taking the sublingual dose.

• Tachycardia: Reflex rapid heartbeat.

• Tolerance: Long-term use reduces efficacy if a “drug-free interval” is not maintained.

• Storage: Keep the sublingual tablets in the original glass bottle and close it tightly immediately after use. Discard 8 weeks after opening.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep away from fire or heat sources.