Description

Isosorbide Dinitrate Tablets (5mg / 10mg / 20mg)

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 Dinitrate Tablets in India, producing essential cardiac medications for the management of Angina Pectoris and Congestive Heart Failure. Isosorbide Dinitrate (ISDN) is a Nitrate Vasodilator that widens blood vessels to improve blood flow to the heart muscle.

We offer Contract Manufacturing (Third Party) services for this product. Handling nitrates requires specialized safety protocols due to the nature of the API. Our WHO-GMP certified facility in Mumbai is equipped to safely process diluted nitrate mixtures, ensuring precise dosage and stability. Healthy Inc manages the export logistics, supplying hospitals and distributors across Latin America, Asia, and the Middle East.

2. Product Specifications

3. Manufacturing Isosorbide Dinitrate Tablets

Manufacturing nitrates requires expertise in safety and blending.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  Pure Isosorbide Dinitrate is volatile. We handle the “diluted” raw material (mixed with lactose/mannitol) under strict environmental controls. We use Direct Compression or specialized dry granulation techniques to ensure the active ingredient is evenly distributed without exposing it to excess heat or friction. This guarantees that every 10mg tablet provides consistent therapeutic effect without potency loss.

• The Exporter: Healthy Inc

  Healthy Inc ensures safe global distribution. We use moisture-proof packaging (Alu-PVC or Alu-Alu) because nitrates can degrade if exposed to humidity. We handle all dangerous goods (DG) declarations if required for specific concentrations during shipping, ensuring smooth customs clearance.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We confirm the exact amount of Isosorbide Dinitrate (90-110% limits) using HPLC.

• Content Uniformity: Vital for low-dose tablets (5mg) to ensure no dose dumping.

• Disintegration: For sublingual variants, we test for rapid disintegration (< 2 minutes) to ensure quick absorption.

5. Why Use Isosorbide Dinitrate Tablets?

It is a cornerstone therapy for preventing chest pain.

• Mechanism: It releases nitric oxide (NO) in the body, which relaxes the smooth muscles of the blood vessels (vasodilation). This reduces the workload on the heart (preload/afterload) and improves oxygen supply.

   

• Key Indications:

  • Angina Pectoris: Prophylaxis (prevention) of angina attacks.

     

  • Heart Failure: Used in combination with Hydralazine for chronic heart failure management.

     

  • Esophageal Spasms: Off-label use for relief of spasms.

     

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 Dinitrate Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India with nitrate handling expertise.

• Q: Is this the same as Isosorbide Mononitrate?

  A: No. Dinitrate is short-acting and taken multiple times a day. Mononitrate is long-acting and usually taken once daily.

• Q: Can these be used for acute attacks?

  A: Sublingual 5mg tablets can be used for acute attacks, but oral tablets are generally for prevention.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Oral: Typically 5mg to 20mg taken 2 to 3 times daily.

• Sublingual: 2.5mg to 5mg dissolved under the tongue for rapid onset.

• Tolerance: A “nitrate-free interval” of 10-12 hours daily is recommended to prevent the body from developing tolerance to the drug.

   

9. Side Effects and Precautions

• Common Side Effects: “Nitrate Headache” (very common), flushing, dizziness, and hypotension (low blood pressure).

   

• Contraindications: Do not take with PDE5 inhibitors (like Sildenafil or Tadalafil) as this can cause a fatal drop in blood pressure.

   

• Precautions: Caution in patients with severe anemia or head trauma.

10. Storage Instructions

• Store below 30°C in a dry place.

• Keep tightly closed to prevent moisture absorption.