Description

Etofylline & Theophylline Tablets

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 Etofylline & Theophylline Tablets in India. This fixed-dose combination is a classic and highly affordable Bronchodilator therapy used extensively in the management of Asthma and Chronic Obstructive Pulmonary Disease (COPD). While newer inhalers exist, this oral combination remains a cornerstone of maintenance therapy in many developing markets due to its cost-effectiveness and efficacy in preventing nocturnal (night-time) bronchospasm.

We offer Contract Manufacturing (Third Party) services for both Immediate Release and Prolonged Release (Retard/SR) formulations. Theophylline has a narrow therapeutic index. Our WHO-GMP certified facility in Mumbai utilizes high-precision blending and Matrix Tablet Technology to ensure the drug releases steadily, maintaining safe blood levels and preventing the “peaks” that cause side effects like palpitations. Healthy Inc manages the export logistics, supplying respiratory clinics and pharmacy chains across Africa, Southeast Asia, and the CIS region.

2. Product Specifications

3. Manufacturing Technology

Balancing solubility and safety.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Synergy Optimization: Theophylline is poorly soluble in water. Etofylline is chemically similar but highly soluble. By combining them, we improve the overall solubility and absorption profile of the medication, ensuring faster onset of action than Theophylline alone.

  • Retard Matrix (SR): For the “Retard” dosage, we embed the active ingredients in a Hydrophilic Polymer Matrix. This regulates the release rate over 12 hours, allowing for twice-daily dosing and ensuring the patient sleeps through the night without waking up wheezing.

  • Precise Dosing: Since Theophylline toxicity is a concern, our automated granulation lines ensure strict content uniformity, guaranteeing that no tablet contains an overdose.

• The Exporter: Healthy Inc

  • Institutional Packs: We specialize in cost-effective blister packs and bulk jars for hospital formularies where oral bronchodilators are the primary line of defense.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • Immediate Release: >80% release in 45 minutes.

  • Retard: Tested at 1h, 4h, and 8h to verify sustained release profile.

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

• Related Substances: We strictly monitor for degradation products to ensure safety.

5. Why Use This Combination?

Opens the airways when breathing is hard.

• Mechanism: Both drugs are Methylxanthines. They work by inhibiting the enzyme Phosphodiesterase (PDE) in the smooth muscle cells of the airways. This increases cAMP levels, causing the bronchial muscles to relax and airways to widen. They also stimulate the respiratory center in the brain, improving the drive to breathe.

• Key Indications:

  • COPD: Long-term maintenance to prevent breathlessness.

  • Asthma: Prevention of attacks (especially effective for night-time symptoms).

  • Bronchitis: Relieves wheezing associated with chronic bronchitis.

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 Etofylline Theophylline Tablets?

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

• Q: Is it Deriphyllin?

  A: Deriphyllin is the famous brand name (Zydus). We manufacture the Generic Equivalent, which contains the exact same ratio of Etofylline and Theophylline.

• Q: Can I drink coffee with it?

  A: Avoid excess caffeine. Coffee contains caffeine, which is chemically related to Theophylline. Taking both together can increase jitteriness, heart rate, and insomnia.

• Q: Does smoking affect the dose?

  A: Yes. Smoking makes the liver break down Theophylline faster. If you quit smoking while taking this drug, your doctor may need to lower your dose to prevent toxicity.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Tablet (100mg): 1 tablet three times daily.

• Retard Tablet (300mg): 1 tablet once or twice daily (every 12 hours).

• Administration: Take with plenty of water. Taking after meals reduces gastric irritation (nausea). Swallow Retard tablets whole; do not chew.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, vomiting, stomach pain (very common).

• CNS: Headache, insomnia, restlessness, tremors.

• Cardiac: Tachycardia (fast heart rate), palpitations.

• Toxicity: Narrow therapeutic window. Monitor serum levels if signs of toxicity (severe vomiting, seizures) appear.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.