Volume-2 ,Issue-7, July- 2026

The present study focused on the development, optimization, and evaluation of a bilayer tablet containing N-acetylcysteine (NAC) and acebrophylline for the management of productive airway diseases such as COPD, chronic bronchitis, and bronchial asthma. The formulation combined an immediate-release NAC layer for rapid mucolytic action with a sustained-release acebrophylline layer for prolonged bronchodilator and anti-inflammatory effects. Sustained-release formulations (F1–F7) were evaluated for flow properties, compression characteristics, mechanical strength, drug content, and dissolution behavior. The optimized formulation F7 showed acceptable hardness, low friability, rapid NAC release above 90% within 30 minutes, and controlled acebrophylline release up to 24 hours. Release kinetics indicated anomalous non-Fickian diffusion involving polymer swelling, diffusion, and erosion. RP-HPLC validation and stability studies confirmed formulation reliability and stability. Overall, the bilayer tablet approach offers a promising fixed-dose delivery system that may improve therapeutic effectiveness and patient adherence in chronic respiratory disorders.

Keyword: Acebrophylline, N-acetylcysteine, bilayer tablet, sustained release, immediate release, COPD, asthma, hydrophilic matrix, HPMC K100M.