Description

Diltiazem Tablets (30mg / 60mg / 90mg 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 Diltiazem Hydrochloride Tablets in India. Diltiazem is a prominent Calcium Channel Blocker (Non-Dihydropyridine) used extensively for the management of Chronic Stable Angina, Hypertension, and rate control in Atrial Fibrillation. Unlike other calcium channel blockers (like Amlodipine), Diltiazem offers a dual benefit: it relaxes blood vessels to lower pressure and regulates the heart rate, making it ideal for patients with rapid heart rates or ischemic heart disease.

We offer Contract Manufacturing (Third Party) services for both Immediate Release (IR) and Sustained Release (SR) formulations. Our WHO-GMP certified facility in Mumbai utilizes advanced Hydrophilic Matrix Technology for our SR tablets, ensuring a steady, controlled release of the drug over 12 hours. This reduces the dosing frequency, improving patient adherence compared to older formulations. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across the Middle East, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Controlled release for consistent heart protection.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Matrix Technology (SR): For our Sustained Release (SR) tablets, we embed the Diltiazem in a polymer matrix (HPMC). Upon contact with fluid, the tablet forms a gel layer that regulates the drug’s diffusion. This prevents “dose dumping” and ensures therapeutic coverage lasts for 12 hours.

  • Direct Compression (IR): Our immediate-release tablets are manufactured using direct compression to ensure rapid disintegration (< 15 mins), providing quick relief for acute angina episodes.

  • Light Stability: Diltiazem is sensitive to light. We use opaque blister films (PVC/PVDC or Alu-Alu) to protect the product from photodegradation.

• The Exporter: Healthy Inc

  • Versatile Packaging: We can supply bulk packs for hospitals (where unit-dose usage is high) or retail-ready blisters with patient information leaflets in multiple languages (English, Spanish, French).

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • IR: >80% release in 30 minutes.

  • SR: Tested at 1h, 4h, and 8h intervals to confirm the sustained release profile matches the innovator.

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

• Related Substances: We strictly monitor for Desacetyl Diltiazem (a metabolite/impurity) to ensure stability.

5. Why Use Diltiazem?

Relaxes the vessels, calms the heart.

• Mechanism: Diltiazem inhibits the influx of calcium ions into cardiac muscle cells and vascular smooth muscle cells during depolarization.

  • Vasodilation: It relaxes coronary arteries, increasing oxygen supply to the heart (Anti-Anginal).

  • Rate Control: It slows conduction through the AV node, reducing heart rate in arrhythmias like Atrial Fibrillation.

• Key Indications:

  • Angina Pectoris: Prevents chest pain caused by exercise or stress.

     

  • Hypertension: Lowers blood pressure (often used when beta-blockers are contraindicated).

     

  • Arrhythmias: Controls rapid heart rate in AFib or Flutter.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies for SR) 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 Diltiazem Tablets?

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

• Q: Is it Cardizem?

  A: Cardizem is the brand name (Bausch). We manufacture the Generic Equivalent (Diltiazem HCl), which works exactly the same.

• Q: What is the difference between IR and SR?

  A: IR (Immediate Release): Works fast, taken 3-4 times a day. SR (Sustained Release): Works slowly, taken twice a day.

• Q: Can I stop taking it suddenly?

  A: NO. Sudden withdrawal can cause “Rebound Angina” or a sudden spike in blood pressure. Dose must be tapered off.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Angina / Hypertension:

  • IR: Start 30mg four times daily. Increase gradually to 180-360mg/day.

  • SR: 60mg to 120mg twice daily.

• Administration: Swallow whole. Do not crush or chew SR tablets. Can be taken before meals and at bedtime.

9. Side Effects and Precautions

• Cardiovascular: Bradycardia (slow heart rate), Edema (swelling of ankles), Hypotension (low BP).

• Gastrointestinal: Constipation (less than Verapamil), nausea.

• Contraindications: Sick Sinus Syndrome, 2nd/3rd Degree AV Block (unless pacemaker present), and severe hypotension.

• Interaction: Increases levels of Digoxin and Statins (Simvastatin/Atorvastatin). Dose adjustments required.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.