Description

Pentoxifylline Extended-Release Tablets (400mg)

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 Pentoxifylline Extended-Release (ER) Tablets in India. Pentoxifylline is a unique Hemorheologic Agent (blood viscosity reducer) used to treat Intermittent Claudication resulting from peripheral vascular disease. It improves blood flow to the limbs by making blood cells more flexible and less sticky, allowing patients to walk longer distances without pain.

We offer Contract Manufacturing (Third Party) services for this complex modified-release formulation. Pentoxifylline can cause significant gastric irritation (nausea/vomiting) if released too quickly. Our WHO-GMP certified facility in Mumbai utilizes advanced Hydrophilic Matrix Technology to ensure the drug releases slowly and consistently over 12 hours, improving tolerability. Healthy Inc manages the export logistics, supplying vascular clinics and geriatric care centers across the Middle East, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Controlled release is the safety mechanism.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Matrix Technology: We formulate the tablet using high-viscosity HPMC (Hydroxypropyl Methylcellulose) polymers. When swallowed, the tablet forms a gel layer that controls the diffusion of the drug. This prevents “dose dumping” and ensures steady blood levels, which is critical for minimizing side effects like dizziness and nausea.

  • Film Coating: We use a specialized cosmetic coating to make the large tablet easier to swallow and to protect the core from moisture.

  • Uniformity: Precise blending ensures that the release rate is consistent from batch to batch.

• The Exporter: Healthy Inc

  • Stability Protection: We utilize high-barrier PVDC or Alu-Alu Blisters to protect the hydrophilic matrix from humidity, which could otherwise alter the drug release profile during storage.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (12-Hour Profile): We test drug release at multiple time points (e.g., 1hr, 4hr, 8hr, 12hr) to validate the Extended-Release claim.

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

• Impurity Profiling: We strictly monitor for related substances to ensure safety over the shelf life.

5. Why Use Pentoxifylline?

It improves the “flow properties” of blood.

• Mechanism: It acts on red blood cells (RBCs), making them more flexible (deformable) so they can squeeze through narrowed capillaries. It also reduces fibrinogen levels and prevents platelet aggregation (clumping).

• Key Indications:

  • Intermittent Claudication: Leg pain/cramping induced by exercise due to blocked arteries.

  • Venous Leg Ulcers: (Off-label) Used to improve healing of chronic leg ulcers.

  • Alcoholic Hepatitis: (Off-label) Sometimes used to reduce liver inflammation (anti-TNF effects).

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) 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 Pentoxifylline Tablets?

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

• Q: Can I crush the tablet?

  A: NO. Crushing destroys the “Extended Release” mechanism. This would release 400mg at once, causing severe nausea, dizziness, or fainting. Swallow whole.

• Q: How long does it take to work?

  A: It is not immediate. It typically takes 2 to 4 weeks to notice an improvement in walking distance, and up to 8 weeks for the full benefit.

• Q: Does it thin the blood?

  A: Yes, it has mild anti-clotting effects. Caution is needed if taking Warfarin or other blood thinners.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 400mg three times daily (TID) with meals.

• Administration: Must be taken with food to reduce digestive upset. Swallow whole.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, vomiting, dyspepsia, and bloating. (Taking with food helps).

• CNS: Dizziness, headache, tremors.

• Cardiovascular: Flushing, angina, or arrhythmia (rare).

• Bleeding: Potential risk of bleeding if combined with anticoagulants.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture.