Design, formulation, optimization and stability studies of paracetamol effervescent tablets

The purpose of the current study was to develop stable effervescent-tablets without controlling area relativehumidity; temperature and no requirement of special packaging. Current 3(2) factorial-design experimental studies were conducted in the Research Laboratory of Pharmaceutics, Hamdard University. Duration of study is from December-2021 to November-2022. Various paracetamol based effervescent formulations (F1-F9) were prepared with different molar-ratio of citric-acid anhydrous and sodium-bicarbonate as independent variables. Design-Expert((R)) software was used to graphically express the influence of each factor. By novel approach; tablets were compressed at ambient temperature and relative-humidity; acid components were kept on one-side and basic ingredients on another side; both sides were separated by an inert-layer. Tablets were kept at accelerated humidity and temperature in normal packing for six months; after six months, F6 formulation was found acceptable based on effervescence-time (120 sec), pH-value (5.5) and other quality criterion. Parameters of assay, effervescence-time, pH-value and carbon-dioxide content were found within the set-limit. Hence; novel approach for developing effervescent formulation by separating acid components at one-side and basic ingredients on another side of tablet through inert-layer is workable under room temperature and humidity. It is expected that commercial production of tablets by this technique may reduce cost of effervescent products and no requirement for special packaging.