Description

Nitroglycerin Controlled Release Tablets (2.6mg / 6.4mg)

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 Nitroglycerin (Glyceryl Trinitrate) Controlled Release Tablets in India. While Nitroglycerin is famous for acute sublingual use, our Controlled Release (CR) tablets are designed for the Prophylaxis (Prevention) of Angina Pectoris. They provide continuous protection against chest pain for patients with Coronary Artery Disease, allowing them to engage in daily activities with reduced fear of attacks.

We offer Contract Manufacturing (Third Party) services for this high-risk formulation. Handling Nitroglycerin (an explosive nitrate) requires specialized safety infrastructure and licensing. Our WHO-GMP certified facility in Mumbai utilizes dedicated containment zones and explosion-proof processing suites. We formulate these tablets using a stable matrix system that allows for standard blister packaging, unlike sublingual tablets which often require glass bottles due to volatility. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across Europe, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Safety and stability are the primary challenges.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Explosion Proof Processing: Nitroglycerin API is adsorbed onto a lactose base (Diluted Nitroglycerin) to render it safe for handling. We process this in specialized suites designed to dissipate static electricity and heat to prevent accidental ignition.

  • Controlled Release Matrix: We use a hydrophilic polymer matrix that slowly releases the drug over 6-8 hours. This maintains a steady therapeutic level in the blood, preventing the “rebound angina” that can occur if the drug wears off too quickly.

  • Stabilization: Nitroglycerin is volatile (it can evaporate from the tablet). We use specific binding agents to lock the molecule into the tablet core, ensuring potency is maintained throughout the shelf life.

• The Exporter: Healthy Inc

  • Cold Chain/Cool Storage: While the tablets are stable, we recommend cool storage during shipping to prevent migration of the active ingredient, especially in hot export markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (CR Profile): We test release at 1hr, 4hr, and 8hr intervals to confirm the “Controlled Release” mechanism is functioning correctly.

• Content Uniformity: Crucial for low-dose potent drugs. We ensure every tablet contains exactly 2.6mg or 6.4mg.

• Potency: We strictly monitor for loss of potency due to volatilization.

5. Why Use Nitroglycerin CR?

It prevents the pain before it starts.

• Mechanism: It releases Nitric Oxide (NO) in the body, which relaxes vascular smooth muscle. This dilates veins (reducing preload/blood return to the heart) and arteries (reducing afterload). This lowers the heart’s oxygen demand.

• Key Indications:

  • Angina Pectoris Prophylaxis: Long-term prevention of chest pain.

• Important Distinction: These tablets are NOT for acute attacks. They take too long to start working. Patients must still carry a Sublingual Spray or Tablet for emergencies.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Stability Data) 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 Nitroglycerin Tablets?

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

• Q: Can I use this when I feel chest pain?

  A: NO. This is a “Preventative” tablet. It releases slowly. For sudden chest pain, use a sublingual tablet or spray.

• Q: Why do I get a headache?

  A: “Nitrate Headache” is a very common side effect caused by the widening of blood vessels in the brain. It usually goes away after a few days of use.

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

  A: ABSOLUTELY NOT. Combining Nitroglycerin with PDE5 inhibitors (Viagra, Cialis) can cause a fatal drop in blood pressure. This is a life-threatening interaction.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 2.6mg or 6.4mg twice daily.

• Nitrate Tolerance: To prevent the body from getting used to the drug (Tolerance), there must be a 10-12 hour “Nitrate-Free Interval” every day (usually at night). For example, take doses at 8 AM and 2 PM, leaving the night free.

• Administration: Swallow whole with water. Do not crush or chew.

9. Side Effects and Precautions

• Headache: Throbbing headache (very common).

• Hypotension: Dizziness, lightheadedness, or fainting (syncope), especially when standing up quickly.

• Flushing: Warmth/redness of the face.

• Interaction: Contraindicated with Sildenafil, Tadalafil, or Vardenafil.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.