Description

Isosorbide Mononitrate Tablets (10mg / 20mg / 40mg / SR)

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 Isosorbide Mononitrate Tablets in India, producing high-quality long-acting cardiac medications. Isosorbide Mononitrate (ISMN) is a potent Nitrate Vasodilator used for the long-term management and prophylaxis (prevention) of Angina Pectoris (chest pain) due to coronary artery disease.

We offer Contract Manufacturing (Third Party) services for both Immediate Release and Sustained Release (SR/ER) formulations. Unlike Isosorbide Dinitrate, the Mononitrate form has nearly 100% bioavailability. Our WHO-GMP certified facility in Mumbai utilizes advanced matrix technology to ensure consistent drug release profiles. Healthy Inc manages the export logistics, supplying hospitals and distributors across Latin America, Southeast Asia, and the Middle East.

2. Product Specifications

3. Manufacturing Isosorbide Mononitrate Tablets

Manufacturing long-acting nitrates requires precise polymer blending.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  For our Sustained Release (SR) tablets, we use hydrophilic matrix polymers (like HPMC). When the tablet contacts fluid in the stomach, it forms a gel layer that releases the drug slowly over 12-24 hours. This technology prevents “dose dumping” and ensures 24-hour protection against angina attacks. We handle the raw material with strict safety protocols as nitrates can be sensitive to friction and static.

• The Exporter: Healthy Inc

  Healthy Inc ensures safe global distribution. We focus on high-barrier packaging to prevent moisture absorption, which can alter the drug release profile. We manage the Dangerous Goods (DG) class regulations if applicable for specific bulk shipments, ensuring seamless customs clearance at destination ports.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution Profiling: For SR tablets, we test release at multiple time points (1h, 4h, 8h, 12h) to confirm the sustained release mechanism works correctly.

• Assay: We confirm the potency is within 90-110% limits using HPLC.

• Content Uniformity: We ensure every tablet contains the exact dose to prevent blood pressure fluctuations.

5. Why Use Isosorbide Mononitrate?

It is the preferred nitrate for daily maintenance.

• Mechanism: It releases nitric oxide (NO), relaxing vascular smooth muscle. This dilates peripheral arteries and veins, reducing the heart’s workload (preload and afterload) and oxygen demand.

• Advantages over Dinitrate: It does not undergo “first-pass metabolism” in the liver, meaning nearly 100% of the drug is available to the body. This makes dosing more predictable.

• Key Indications:

  • Angina Pectoris: Prevention of chronic stable angina.

  • Not for Acute Attacks: It acts too slowly to stop an attack that has already started.

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 Isosorbide Mononitrate Tablets?

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

• Q: Can I split the SR tablet?

  A: Usually, SR tablets should not be crushed or chewed, as this destroys the slow-release mechanism. However, scored tablets can sometimes be split (check specific product instructions).

• Q: Why do patients get headaches?

  A: This is a common side effect of vasodilation (widening of blood vessels) in the brain. It usually subsides after a few days of use.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Immediate Release: Typically 20mg twice daily, with the two doses taken 7 hours apart (e.g., 8 AM and 3 PM).

• Sustained Release (SR): Usually taken once daily in the morning (30mg or 60mg).

• Nitrate-Free Interval: Essential to maintain a 10-12 hour period without nitrate in the blood daily to prevent tolerance.

9. Side Effects and Precautions

• Common Side Effects: Headache, flushing, dizziness, and hypotension.

• Contraindications: strictly contraindicated with PDE5 inhibitors (Sildenafil, Tadalafil) due to risk of severe hypotension.

• Precautions: Use with caution in patients with severe hypotension or hypovolemia.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep tightly closed.