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Effervescent formulation helps in faster and better absorption of drugs, especially those that are rapidly soluble in water. However, these tablets require special packaging in order to prevent them from absorbing moisture, hence increasing cost. We compared an effervescent tablet prepared using an in-house developed method (multi-layer tablet with acid and base part separated by an inert layer) to a European effervescent tablet (Efferalgan®) in a single-center, randomized cross-over study among twelve healthy volunteers. Blood samples were collected for 8 h and analyzed for paracetamol concentration using HPLC. Our results showed that both the products have similar pharmacokinetic profiles with no significant difference observed for Clast, Thalf, Kelim, and MRT (p-value > 0.05). Moreover, to assess bioequivalence we did not find any significant difference (p-value > 0.05) in AUC (27.12 ± 6.02 vs. 27.29 ± 2.64 µg.h/ml), Cmax (7.42 ± 1.06 vs. 7.83 ± 1.19 µg/ml) and tmax (0.85 ± 0.22 vs. 0.83 ± 0.25 h). The TR ratios for AUC, Cmax, and tmax were 0.99, 0.95, and 1.02 respectively, and were all within the specified FDA limits i.e., 0.8–1.25. We found our test tablet to be bioequivalent to that of Efferalgan®. [ABSTRACT FROM AUTHOR]

The purpose of the current study was to develop stable effervescent-tablets without controlling area relativehumidity; temperature and no requirement of special packaging. Current 3² 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 molarratio of citric-acid anhydrous and sodium-bicarbonate as independent variables. Design-Expert® 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. [ABSTRACT FROM AUTHOR]