Asian Journal of Pharmacy and Technology

Ravindra Babu Baggi ¹, Naveen Babu Kilaru ²

Affiliations
1 Department of Pharmaceutics, Sri Siddhartha Pharmacy College, Nuzvid, 521201, IN
2 Department of Pharmaceutical Biotechnology, KVSR Siddhartha Pharmacy College, Vijayawada, 520010, IN

Abstract

The aim of this study was to design and evaluate controlled-release formulations of a model drug, Nicorandil using gastroretentive approach. The dissolution test was employed using 0.1N HCL (pH 1.2) to measure the in vitro release behaviour of Nicorandil formulations. The best formulation of MCS4 is selected based on the identical drug release profile with theoretical release data which follows zero order and Higuchi model based on their higher square of correlation coefficient (R²) and adjusted coefficient of determination (R^̅2). In order to evaluate the modeling of drug release from swellable polymeric systems, the drug release data was fitted into Korsmeyer-Peppas equation and the model showed higher R² and R^̅2 (0.9974 and 0.9971, respectively) with the diffusional exponent value (n) of 0.87. Further, the drug release of best formulation is checked for its deviation from an ideal release profile of Peppas model and confirmed that the test formulation is slightly deviate the ideal Peppas model.

Keywords

Controlled Release, Buoyancy, Diffusional Exponent, Percent Deviation, Two-Tiered Method.

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Ravindra Babu Baggi ¹, Naveen Babu Kilaru ²

Affiliations
1 Department of Pharmaceutics, Sri Siddhartha Pharmacy College, Nuzvid, 521201, IN
2 Department of Pharmaceutical Biotechnology, KVSR Siddhartha Pharmacy College, Vijayawada, 520010, IN

Abstract

The objective of this study was to develop Nicorandil controlled release floating tablets using combination of hydrophilic and hydrophobic polymers by melt granulation technique. The in vitro drug release characteristics were determined using USP XXII type 2 (paddle type) apparatus, in a medium of 0.1N HCL. The dissolution profile of all the batches were extended up to 24 hrs. To study and model the drug delivery from polymeric floating tablets, the dissolution data was fitted to a pioneered method Korsmeyer-Peppas equation. The results indicate that, all the formulations followed super Case-II release mechanism, except MCS4 which followed non- Fickian or anomalous release mechanism. In order to determine the predominant mechanism (diffusion/ relaxation model), drug release data was incorporated into Peppas-Sahlin model. The results revealed that, Fickian release contribution was preponderance than corresponding Case-II relaxational contribution in all the formulations. In addition to this, the relaxational contribution was observed with negative sign in all the formulations but, only at specific time intervals. Relaxational contribution with negative values indicates the Fickian release mechanism was more pronounced than relaxation i.e. almost the relaxational mechanism was absent.

Keywords

Controlled Release, Nicorandil, Diffusion, Relaxation, Fickian Diffusion.

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Ravindra Babu Baggi ¹, Naveen Babu Kilaru ²

Affiliations
1 Department of Pharmaceutics, Sri Siddhartha Pharmacy College, Nuzvid, 521201, IN
2 Department of Pharmaceutical Biotechnology, KVSR Siddhartha Pharmacy College, Vijayawada, 520010, IN

Abstract

The objective of this study was to develop Nicorandil floating tablets by melt granulation technique using combination of almond gum as swellable plus retarding polymer and cetosteryl alcohol as waxy plus retarding polymer. The drug release mechanism is analysed by both Higuchi model and Hixson-Crowell model based on their higher square of correlation coefficient (R2). The best formulation of MCS4 is selected based on the identical drug release profile with theoretical release data calculated from Robinson Erickson equation which follows Higuchi model for drug release from tablet core. Further, the drug release of best formulation which follow Higuchi model is checked for its deviation from an ideal Higuchi release profile. The release profiles of the best formulation is greatly deviate the ideal Higuchi release profile. In order to minimise the deviation, twotiered method is used and confirm the drug release at two phases as Hixson-Crowell model for first phase and Higuchi model for second phase.

Keywords

Controlled Release, Nicorandil, Higuchi Model, Hixson-Crowell Model, Hydrophilic Gum, Hydrophobic Polymer.

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