In the pharmaceutical industry, Theophylline 200 mg is a classic Methylxanthine derivative and a systemic bronchodilator. As a pharmacist and manufacturer, I classify this as a “sustained-release” or “maintenance” therapy for chronic respiratory conditions.Unlike rescue inhalers (like Salbutamol), Theophylline is generally used to provide long-term, around-the-clock control of airway obstruction.
Primary Clinical Uses
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Chronic Asthma: For the prevention and long-term maintenance of asthma symptoms, particularly nocturnal asthma (nighttime wheezing).
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COPD (Chronic Obstructive Pulmonary Disease): Management of stable chronic bronchitis and emphysema.
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Apnea of Prematurity: In specialized neonatal care, it is used to stimulate breathing in premature infants.
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Maintenance Therapy: Used when patients are not adequately controlled by inhaled corticosteroids or long-acting beta-agonists (LABAs).
Mechanism of Action: Phosphodiesterase Inhibition
Theophylline works through a dual pathway to open the airways and reduce the inflammatory response.
PDE Inhibition: It inhibits the enzyme Phosphodiesterase (PDE). This leads to an increase in intracellular cyclic AMP (cAMP), which triggers the relaxation of bronchial smooth muscles (bronchodilation).
Adenosine Antagonism: It blocks Adenosine receptors, which otherwise cause bronchoconstriction and the release of histamine.
Diaphragm Strengthening: It increases the force of contraction of the diaphragmatic muscles, which is particularly beneficial for patients with COPD who have “tired” respiratory muscles.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your WHO-GMP facility in Mumbai, the 200 mg strength requires specific technical oversight:
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Modified Release (Sustained Release) Technology: The 200 mg dose is most commonly formulated as a Sustained Release (SR) tablet. At our facility, we utilize specialized polymers (like HPMC) to ensure the drug is released slowly over 12 to 24 hours. This is a major USP for your digital platform, as it improves patient compliance.
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Narrow Therapeutic Index (NTI): As a pharmacist, you know Theophylline has a “narrow window” where it is effective but not toxic. For your B2B clients, providing rigorous Batch-to-Batch Dissolution Data is essential to prove your generic version’s safety and bioequivalence.
Stability & Moisture Control: Theophylline is sensitive to moisture. We utilize Alu-Alu blister packaging to ensure a 36-month shelf life, especially for export to Zone IVb regions where high humidity can affect the release profile of SR tablets.
Dossier Support: This molecule is a staple in international public health tenders. Our Mumbai facility provides full CTD/eCTD Dossiers to support your firm in registering this as a reliable generic against the innovator (Theolair or Quibron).