DESIGN AND EVALUATION OF BILAYERED TABLETS TO TREAT RESPIRATORY TRACT INFECTIONS

摘要

The aim of the present investigation was to develop bilayer tablets for treating respiratory tract infections. In present study Levofloxacin is selected as antibiotic to treat upper and lower respiratory tract infections, but antibiotic taking along with a mucolytic drug shows reduction of acute exacerbation and days of illness. So we selected Ambroxol hydrochloride as mucolytic drug along with antibiotic Levofloxacin. Bi-layered tablets were formulated consisting of Levofloxacin as immediate release layer and Ambroxol HCL as sustain release layer because its half life is only 4 hours so it will not produce pharmacological effect along with Levofloxacin, so Ambroxol layer is sustained by using polymers. Levofloxacin IR layer was prepared, by using starch as disintegrant which shows sufficient hardness and friability and released the drug within one hour. Ambroxol HCL SR layer was prepared, by using HPMC K4M (11%) and HPMC K100M (12.5%) mixture, sustained the drug release upto 12thhour. Bilayer tablets prepared by wet granulation method were evaluated for thickness, hardness, weight variation, friability and drug content. FT-IR studies clearly indicated that there was no drug-polymer interaction. In total 12 formulations F11 batch releases the Ambroxol HCL in sustained manner similar to the release given by marketed sample and same batch releases the Levofloxacin immediately within an hour. The optimized batch was selected for stability studies and confirmed that there was no significant difference over a stability testing period