Assessment of Dissolution Profile of Marketed Aceclofenac Formulations

Abstract

Statistical comparison of dissolution profiles under a variety of conditions relating to formulation characteristics, lot-to-lot, and brand-to-brand variation attracts interest of pharmaceutical scientist. The objective of this work is to apply several profile comparison approaches to the dissolution data of five-marketed aceclofenac tablet formulations. Model-independent approaches including ANOVA-based procedures, ratio test procedure, and pair wise procedure. The ratio test includes percentage, area under the curve, mean dissolution time, while the pair wise procedure includes difference factor (f1), similarity factor (f2), and Rescigno index. In the model-dependent approach, zero order, first order, Hixson-Crowell, Higuchi, and Weibull models were applied to the utilization of fit factors. All the approaches were applicable and useful. ANOVA with multiple comparison tests was found to be sensitive and discriminating for comparing the profiles. Weibull parameters were more sensitive to the difference between two release kinetic data in terms of curve shape and level.

Improved Dissolution Behavior of Aceclofenac Loadings with Kollidon VA 64 Using Spray Drying and Rotary Evaporation Process

“…Unless the solvent is eliminated completely, it could remove the solvent under high vacuum. In this study, Kollidon VA 64 25,26 was used as a polymeric carrier of aceclofenac to prepare solid dispersions. Kollidon VA 64 is a white or yellowish powder and has a molecular weight of 45000 to 70000.…”

Formulation and evaluation of Bacillus coagulans-loaded hypromellose mucoadhesive microspheres

“…A mean value of three determinations at each time point was used to fit an in vitro drug dissolution profile of all formulation batches to different kinetic models so as to find the best fitting kinetic model and to determine their release exponents, while the mean value of twelve determinations was used to estimate the factors of the model-independent approach. 26,27 In vitro release kinetic studies, statistical evaluation, data fitting, nonlinear least square curve fitting, simulation, and plotting were performed using Excel software (v 2007; Microsoft Software Inc, Redmond, WA) so as to determine the parameters of each equation.…”

“…Normally, regulatory authorities have set a public standard of f 1 values between 1 and 15, and f 2 values between 50 and 100 to indicate similarity between two dissolution profiles, while the ξ 1 and ξ 2 indices always present values between 0 and 1 inclusive, where an index value of 0 denotes two identical release profiles, and a value of 1 denotes when the drug from either the test or the reference is not released at all. 26,27 Data from Table 5 reveal that, for all formulation pairs, the ξ 1 values lie between 0.06 and 0.24, and ξ 2 values lies between 0.14 and 0.32 (ie, above 0 and below 1), and the f 1 value lies between 16.85 and 42.60 (ie, above 15), and for almost all formulation pairs, the f 2 value lies between 27.54 and 50.00 (ie, below 50) indicating dissimilarity in product performance of the formulation batches when compared to each other, ie, intrapolymer (having the same grade of hypromellose but differing from each other by B. coagulansto-hypromellose ratio) and interpolymer (having the same Table 6. The mechanism of B. coagulans release from the microspheres follows the zero-order kinetic model, since the plot of cumulative percent viable cell release versus time were found to be linear, and have a highest regression coefficient (r 2 ) value in comparison to that of the first order, Hixson-Crowell, and Weibull model when compared with intraformulation batches.…”

“…1, case-2), or parabolic with a higher initial slope, and after that consistent with the exponential (β , 1, case-3), while the location parameter (T d ) characterizes the time interval necessary to dissolve or release 63.2% of the drug present in the pharmaceutical dosage form, determined by employing relation α = (T d ) β from the shape parameter (β) and scale parameter (α). 27 Study of shape parameter values of the Weibull model from Table 6 reveal that the curve is sigmoid or S-shaped with upward curvature followed by a turning point (β . 1), while the T d value of all formulation batches lies between 9.31 and 30.06.…”

Formulation Development, in Vitro Evaluation and Stability Study of Aceclofenac Tablet

“…NSAIDs (non-steroidal anti-inflammatory drugs) are considered to be the first-line drugs in the symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankyliosis spondylitis [4][5][6]. Aceclofenac is one of the emerging NSAID molecules for arthritis treatment.…”