Description

Nifedipine Sustained Release Tablets (10mg / 20mg / 30mg)

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 Nifedipine Sustained Release (SR) Tablets in India. Nifedipine is a potent Calcium Channel Blocker (CCB) (Dihydropyridine class) used for the long-term management of Hypertension (High Blood Pressure) and Chronic Stable Angina.

We offer Contract Manufacturing (Third Party) services for this technically demanding formulation. Nifedipine is extremely photosensitive (degrades rapidly in light) and immediate-release formulations are often associated with dangerous reflex tachycardia. Our WHO-GMP certified facility in Mumbai utilizes specialized light-controlled manufacturing zones (Sodium Vapor Lighting) and advanced polymer matrix technologies to produce Sustained Release tablets. This ensures a slow, steady release of the drug over 12 hours, maintaining stable blood pressure without the “peaks and troughs” that cause side effects. Healthy Inc manages the export logistics, supplying cardiology units and pharmacies across Europe, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Light stability and release control are non-negotiable.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Photosensitivity Control: Nifedipine transforms into an inactive nitrosophenylpyridine derivative if exposed to normal daylight or UV light. We manufacture the entire batch under Yellow Sodium-Vapor Lamps (which emit no UV) to prevent degradation during processing.

  • Sustained Release Matrix: We use a hydrophilic matrix system (using HPMC polymers). When the tablet enters the stomach, the polymer swells to form a gel layer. The drug diffuses slowly through this gel, extending the therapeutic effect to 12+ hours and allowing for twice-daily dosing instead of 3-4 times daily.

  • Micronization: We use micronized API to ensure that despite the slow release mechanism, the drug is fully soluble and bioavailable once released.

• The Exporter: Healthy Inc

  • Alu-Alu Packaging: We strictly recommend Alu-Alu Cold Form Blisters or light-resistant Amber Blisters. Standard PVC allows light penetration, which would ruin the product before it reaches the patient.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (SR Profile): We test release at multiple time points (e.g., 1hr, 4hr, 8hr) to guarantee the “Sustained Release” claim is met.

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

• Related Substances: We strictly monitor for the specific light-degradation impurities (Nitrophenylpyridine analogue) to ensure safety.

5. Why Use Nifedipine SR?

It provides “Smooth Control” of blood pressure.

• Mechanism: It blocks the influx of calcium ions into the smooth muscle cells of the blood vessels and heart. This relaxes the arteries (vasodilation), lowering blood pressure and reducing the workload on the heart (anti-anginal).

• Key Indications:

  • Hypertension: Long-term control of high blood pressure.

  • Chronic Stable Angina: Prevention of chest pain (angina pectoris).

  • Raynaud’s Phenomenon: (Off-label) Used to treat poor circulation in fingers/toes.

• Advantage: Unlike immediate-release Nifedipine (which can cause a dangerous rapid drop in BP and racing heart), SR tablets provide a gentle, safe reduction in pressure.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Dissolution Profiles and 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 Nifedipine SR Tablets?

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

• Q: Can I cut or crush the tablet?

  A: NO. Crushing breaks the SR matrix. This dumps the entire dose into the blood at once, which can cause severe hypotension (low BP) and collapse. Swallow whole.

• Q: Can I use this for a sudden spike in BP?

  A: No. Nifedipine SR is for maintenance. Immediate-release (sublingual) Nifedipine is generally no longer recommended for hypertensive crisis due to stroke risk.

• Q: Can I drink grapefruit juice?

  A: Avoid it. Grapefruit juice inhibits the enzyme (CYP3A4) that breaks down Nifedipine, leading to dangerously high levels of the drug in your body.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 10mg to 20mg twice daily.

• Max Dosage: Up to 60mg per day (titrated slowly).

• Administration: Swallow whole with water. Consistent timing (e.g., 8 AM and 8 PM) is best.

9. Side Effects and Precautions

• Peripheral Edema: Swelling of ankles/feet (common with CCBs due to vasodilation).

• Flushing & Headache: Due to widening of blood vessels.

• Gingival Hyperplasia: Overgrowth of gum tissue (rare, reversible upon stopping).

• Hypotension: Monitor BP regularly.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. (Keep in the blister pack until the moment of use).