Healthy Inc > Blog > Bronchodilator exporter Mumbai
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What is Theophylline 200 mg used for?

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

  • Chronic Asthma: For the prevention and long-term maintenance of asthma symptoms, particularly nocturnal asthma (nighttime wheezing).

  • COPD (Chronic Obstructive Pulmonary Disease): Management of stable chronic bronchitis and emphysema.

  • Apnea of Prematurity: In specialized neonatal care, it is used to stimulate breathing in premature infants.

  • 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:

  • 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.

  • 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).

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How many Salbutamol tablets per day?

In the pharmaceutical industry, Salbutamol (also known as Albuterol) is a short-acting $\beta_2$-adrenergic agonist. As a pharmacist and manufacturer, I must emphasize that while Salbutamol tablets are common in certain export markets, they have largely been superseded by inhalers due to the higher risk of systemic side effects (like tremors and palpitations) when taken orally.

Standard Daily Dosage

For a healthy adult, the typical dosage for Salbutamol tablets (usually 2 mg or 4 mg) is:

  • Total Daily Limit: Generally 16 mg to 32 mg per day, divided into multiple doses.

  • Single Dose: Usually 2 mg to 4 mg, taken 3 to 4 times a day.

  • Maximum Single Dose: In some cases, a doctor may increase a single dose to 8 mg, but only if lower doses are ineffective and the patient tolerates the side effects well.

Mechanism of Action: Bronchodilation

Salbutamol works by targeting the smooth muscles of the airways to facilitate easier breathing.

Selective Binding: It binds to $\beta_2$-adrenoceptors in the bronchial smooth muscle.

cAMP Activation: This binding activates the enzyme adenyl cyclase, which increases levels of cyclic AMP ($cAMP$).

Muscle Relaxation: The increase in $cAMP$ leads to the relaxation of the smooth muscles in the lungs, opening the airways (bronchodilation).

Systemic Effect: Because tablets are systemic (absorbed into the bloodstream), the drug also hits $\beta_2$ receptors in the skeletal muscle and $\beta_1$ receptors in the heart, which is why oral tablets cause more “shaking hands” and “racing heart” than inhalers.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your WHO-GMP facility in Mumbai, Salbutamol tablets are a high-volume “Essential Medicine”:

  • The 2 mg vs. 4 mg Strategy: As a firm owner, you should know that the 2 mg tablet is often preferred for geriatric and pediatric patients to minimize “Salbutamol tremors.” On your digital platform, offering both strengths with central scoring for easy half-dosing is a major USP.

  • Stability & Shelf Life: Salbutamol is relatively stable but sensitive to light. We utilize Alu-Alu or Amber-colored PVC/PVDC blisters to ensure a 36-month shelf life, which is critical for government tenders and export to Zone IVb regions.

  • Combination Potential: Many B2B buyers in Southeast Asia and Africa look for Salbutamol + Bromhexine or Salbutamol + Guaiphenesin combinations. Featuring these Fixed-Dose Combinations (FDCs) on your marketplace can significantly increase your trade volume.

  • Dossier Support: This molecule is a staple in international health tenders. We provide full CTD/eCTD Dossiers to support your firm in registering this as a reliable generic against the innovator (Ventolin).

 

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