New Delhi: Theon Pharmaceuticals Ltd., a leading CDMO in India, has achieved a significant milestone in respiratory therapy with its novel bilayered combination of Acebrophylline 100 mg and Erdosteine 300 mg. It is the first CDMO player in India to receive a DCGI licence for this formulation.
This film-coated bi-layered tablet is indicated for the treatment of chronic bronchitis in patients with COPD, addressing a critical unmet need in long-term respiratory disease management.
This innovative combination brings together two well-established molecules with complementary mechanisms of action. Acebrophylline acts as a bronchodilator and mucoregulator with anti-inflammatory properties, while Erdosteine functions as a potent mucolytic with additional antioxidant and anti-inflammatory benefits. Together, they enhance mucus clearance, reduce airway inflammation, and improve overall pulmonary function.
From a pharmacological perspective, Acebrophylline stimulates surfactant production, reduces bronchial hyper-responsiveness, and improves ventilatory capacity. Erdosteine, on the other hand, reduces mucus viscosity by breaking disulfide bonds, suppresses pro-inflammatory cytokines, and provides antioxidant protection against oxidative stress. This dual mechanism ensures comprehensive respiratory support for patients with COPD and chronic bronchitis.
Key Differentiator – Patented Bi-Layered Technology
One of the most significant advancements in this product is its bi-layered tablet design, which is a patented technology by Theon Pharma. This allows for optimised release kinetics of both molecules, ensuring better therapeutic outcomes, improved patient compliance, and enhanced stability.
Superior to Existing Combinations
This novel combination is positioned as a better alternative to the widely used Acebrophylline + Acetylcysteine combinations offering improved safety, better tolerability, and suitability for long-term therapy.
Commenting on this development, Amit Bansal, Managing Director, Theon Group, said, “This innovative bi-layered combination reflects our commitment to bringing clinically superior and differentiated products to the Indian market. By leveraging advanced formulation technology, we aim to enhance patient outcomes and simplify long-term respiratory disease management.”
Further adding to this, Punit Bansal, Director, Theon Pharma, said, “This development aligns with our vision of strengthening our respiratory portfolio with value-driven innovations. The combination of Acebrophylline and Erdosteine offers a balanced approach to efficacy and safety, especially for chronic therapy, which is critical in COPD management.”
Clinical and therapeutic advantages include:
– Enhanced mucociliary clearance
– Reduction in COPD exacerbations
– Improved lung function and quality of life
– Reduced need for rescue medications
– Better tolerability for long-term use
From a techno-commercial perspective, this product represents a strong opportunity in the respiratory segment, driven by rising COPD prevalence in India. Theon Pharma’s innovation positions it as a differentiated offering in a competitive market.
In conclusion, the Acebrophylline and Erdosteine bi-layered combination marks a significant advancement in respiratory care, combining scientific rationale with patented delivery technology to deliver superior patient outcomes.
(DISCLAIMER: The views expressed are for informational purposes for healthcare professionals and stakeholders.)
