Description

Theophylline Tablets (Immediate & Sustained Release)

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 Theophylline Tablets in India. This is a classic and cost-effective Methylxanthine Bronchodilator used widely for the management of chronic respiratory diseases such as Asthma, Chronic Bronchitis, and Chronic Obstructive Pulmonary Disease (COPD).

We offer Contract Manufacturing (Third Party) services for both Immediate Release and Sustained Release (SR/ER) formulations. Because Theophylline has a Narrow Therapeutic Index (NTI), maintaining stable blood levels is critical. Our WHO-GMP certified facility in Mumbai utilizes advanced hydrophilic matrix technologies (HPMC) for our SR formulations to ensure the drug releases consistently over 12 to 24 hours, preventing “dose dumping” and ensuring around-the-clock symptom control. Healthy Inc manages the export logistics, supplying this essential respiratory medicine to pharmacy chains and government tenders across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Controlling the release profile is the manufacturing priority.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Matrix Technology (SR): For Sustained Release tablets, we use a Hydrophilic Matrix System. The Theophylline is embedded in a polymer (like HPMC). When swallowed, the polymer hydrates to form a gel layer, controlling the diffusion of the drug slowly into the body. This prevents toxic peaks and sub-therapeutic troughs.

  • Content Uniformity: Theophylline is an NTI drug (toxic dose is close to the therapeutic dose). We use Automated Weight Control systems during compression to ensure every tablet contains the exact dosage.

  • Hardness: SR tablets are compressed to a high hardness to ensure the matrix remains intact in the stomach.

• The Exporter: Healthy Inc

  • Stability: Theophylline is stable but can degrade if exposed to extreme conditions. We use robust PVC/PVDC Blisters or Alu-Alu packs to ensure the product withstands the supply chain rigors of export markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution Profiling:

  • IR Tablets: Must release >80% in 45 minutes.

  • SR Tablets: Must follow a strict release curve (e.g., 10-30% in 1st hr, 50-70% in 6th hr, >80% in 12th hr). We test every batch to guarantee this profile.

• Assay: We ensure potency is strictly controlled (90-110%).

• Related Substances: We monitor for impurities like caffeine or other xanthine derivatives.

5. Why Use Theophylline?

It provides affordable, long-term airway control.

• Mechanism:

  • Bronchodilation: It relaxes the smooth muscles surrounding the bronchial tubes (airways), making it easier to breathe.

  • Anti-inflammatory: It has mild anti-inflammatory effects and improves the contraction of the diaphragm (breathing muscle).

• Key Indications:

  • COPD: Long-term maintenance treatment to prevent breathlessness.

  • Nocturnal Asthma: SR formulations are excellent for preventing asthma attacks that occur during sleep.

  • Cost-Benefit: It is significantly more affordable than inhalers or biologics, making it a crucial drug for developing healthcare markets.

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 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 Theophylline Tablets?

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

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

  A: IR (Immediate Release) works quickly but lasts only a few hours (taken 3-4 times a day). SR (Sustained Release) releases slowly and is taken only once or twice a day.

• Q: Does smoking affect this drug?

  A: Yes. Smoking causes the liver to break down Theophylline faster. Smokers may require higher doses, and if they quit smoking, the dose must be reduced immediately to avoid toxicity.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: Highly individualized based on patient weight and serum levels.

  • Adults: Often started at 300mg/day (SR) and titrated up.

• Therapeutic Monitoring: Serum theophylline levels should be monitored (Target: 10-20 mcg/mL).

• Administration: SR tablets must be swallowed whole. Do not crush or chew (this can release a fatal dose at once). Take consistently with or without food.

9. Side Effects and Precautions

• Toxicity Signs: Nausea, vomiting, insomnia, tremors, and palpitations (fast heartbeat). If these occur, check blood levels immediately.

• Seizures: Severe overdose can cause seizures or arrhythmias.

• Interactions: Antibiotics (Erythromycin, Ciprofloxacin) and Cimetidine can increase Theophylline levels to toxic ranges.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.