Description

Theophylline Tablets (100 mg / 300 mg / 400 mg)

Healthy Inc is a specialized global supplier of high-stability respiratory therapies. We provide premium Theophylline Tablets, available in both immediate-release and Sustained-Release (SR) formulations, manufactured in WHO–GMP certified facilities. As a mainstay for obstructive airway diseases, this product is a primary export for pulmonology clinics, chest hospitals, and National Health Tenders in Southeast Asia, Africa, and the CIS region.

Product Overview

Theophylline is a methylxanthine derivative that acts as a potent bronchodilator. It is specifically engineered to manage chronic asthma and Chronic Obstructive Pulmonary Disease (COPD) by relaxing smooth muscles and enhancing respiratory drive.

The “Bronchial Airway” Specialist:

• Double Action Mechanism: Theophylline works primarily by inhibiting phosphodiesterase (PDE), increasing intracellular cAMP which leads to bronchodilation. Secondary, it acts as an adenosine receptor antagonist, preventing adenosine-mediated bronchoconstriction.
• Anti-Inflammatory Properties: At lower serum concentrations, it activates histone deacetylase 2 (HDAC2), which switches off activated inflammatory genes, providing a synergistic effect when used alongside corticosteroids.
• Respiratory Stimulant: It increases the sensitivity of the medullary respiratory center to carbon dioxide and strengthens the contraction of the diaphragm, improving overall ventilatory capacity in COPD patients.

Technical & Manufacturing Specifications

Formulated for precise release kinetics to maintain steady-state serum levels.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.

• Sustained-Release Precision: Because Theophylline has a narrow therapeutic window, our SR tablets utilize a specialized hydrophilic matrix system. This ensures a controlled, zero-order release of the drug over 12–24 hours, preventing toxic peaks and sub-therapeutic troughs.
• Bioavailability Consistency: We perform rigorous comparative dissolution testing at multiple pH levels to ensure our generic formulation is bioequivalent to innovator brands (e.g., Theo-Dur or Uniphyl).
• Environmental Control: Manufactured in humidity-controlled suites to prevent hydration of the anhydrous API, ensuring chemical potency for a 36-month shelf life.

Therapeutic Indications & Clinical Symptoms

• Chronic Asthma: Long-term prophylaxis and treatment of reversible bronchospasm.
• COPD: Management of chronic bronchitis and emphysema symptoms.
• Apnea of Prematurity: Used in specialized neonatal settings as a respiratory stimulant.
• Nocturnal Asthma: SR formulations are particularly effective for “morning dipping” or nighttime wheezing.

Dosage & Administration

• Individualized Dosing: Dosage must be titrated based on clinical response and, ideally, Therapeutic Drug Monitoring (TDM) to maintain serum levels between 10–20 mcg/mL.
• Administration: Sustained-release tablets must be swallowed whole; do not crush or chew.
• Drug Interactions: Caution is required when co-administering with CYP1A2 inhibitors (e.g., Ciprofloxacin) or in smokers, as these factors significantly alter theophylline clearance.

Global Export & Contract Manufacturing Services

Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Pulmonary Hospital Chains and Ministry of Health Tenders. We offer Third Party Manufacturing for Theophylline with full CTD Dossier and COPP support for international registration. Our logistics network ensures streamlined delivery to Vietnam, Nigeria, Kenya, and the CIS region, providing WHO-GMP quality at competitive B2B prices.

Commercial Inquiries

WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in