Aceclofenac Extended Release Matrix Tablets: Formulation and In Vitro Evaluation
Suman Katteboina and Vsr Chandrasekhar P
Abstract
Suman Katteboina and Vsr Chandrasekhar P
Abstract
The objective of the present study was to develop once-daily extended-release matrix tablets of aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID) has been indicated for various painful indications, and proved as effective as other NSAIDs with lower indications of gastro-intestinal adverse effects and thus, resulted in a greater compliance with treatment. Natural polymer, xanthan gum was used as matrix former, microcrystalline cellulose (Avicel PH101), dibasic calcium phosphate (DCP) were used as diluents. The matrix tablets were prepared by direct compression, and were subjected to physical characterization and in vitro release studies. The in vitro drug release was carried out using USP apparatus 2 at 100 rpm in 900 ml of 2% SLS acidic dissolution medium (pH 1.2) for 2 hrs, followed by 900 ml alkaline dissolution medium (pH 6.8) for 3–24 hrs. Formulation was optimised on the basis of acceptable tablet properties and in vitro drug release. The results of dissolution studies indicated that formulation F-II (drug to polymer (1:0.3), the most success of the study, exhibited drug release pattern very close to the marketed extended release profile. By applying exponential equation, optimised formula followed korsmeyer-peppas model with non-Fickian anomalous transport mechanism.
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The objective of the present study was to develop once-daily extended-release matrix tablets of aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID) has been indicated for various painful indications, and proved as effective as other NSAIDs with lower indications of gastro-intestinal adverse effects and thus, resulted in a greater compliance with treatment. Natural polymer, xanthan gum was used as matrix former, microcrystalline cellulose (Avicel PH101), dibasic calcium phosphate (DCP) were used as diluents. The matrix tablets were prepared by direct compression, and were subjected to physical characterization and in vitro release studies. The in vitro drug release was carried out using USP apparatus 2 at 100 rpm in 900 ml of 2% SLS acidic dissolution medium (pH 1.2) for 2 hrs, followed by 900 ml alkaline dissolution medium (pH 6.8) for 3–24 hrs. Formulation was optimised on the basis of acceptable tablet properties and in vitro drug release. The results of dissolution studies indicated that formulation F-II (drug to polymer (1:0.3), the most success of the study, exhibited drug release pattern very close to the marketed extended release profile. By applying exponential equation, optimised formula followed korsmeyer-peppas model with non-Fickian anomalous transport mechanism.
Key concepts: Aceclofenac, Microcrystalline cellulose, Friability, Diluent, Matrix (chemical analysis), Dissolution, Dibasic acid, Chromatography