Abstract

DEVELOPMENT, CHARACTERIZATION AND FUNCTIONALITY EVALUATION OF EFFERVESCENT GRANULES IN ASCORBIC ACID EFFERVESCENT TABLET FORMULATION BY DIRECT COMPRESSION

Amit Raj Sinha*, Dr. Viraj Kulthe and Rauf Pathan

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Abstract

Unit dosage forms, like effervescent tablets are portable and easier to swallow than conventional tablet and liquid formulations. This increases their acceptability and compliance by the patients. Also, they are preferred alternatives to liquid dosage forms for substances exhibiting insufficient stability in aqueous vehicle during storage. A few active substances, like ascorbic acid (vitamin C) are relatively stable in air in their powder form. However, it is unstable in solution undergoing oxidation, in presence of air and light. Thus, formulating moisture-sensitive ingredients, like ascorbic acid into effervescent tablets by wet granulation technique becomes difficult. The present study addresses this challenge by modifying the method of manufacturing effervescent tablets. Readily compressible effervescent granules were obtained by co-processing mannitol, sodium bicarbonate, citric acid and polyvinylpyrrolidone. Then ascorbic acid was formulated into tablet dosage forms by direct compression method containing such co- processed granules and evaluated. This study demonstrated enhanced processability, powder micromeritics, physical stability and performance of the formulation containing ascorbic acid. Thus, the present study highlighted the significance of using coprocessed effervescent granules in formulating moisture-sensitive active ingredients into directly compressible tables.

Keywords: Effervescent granules, effervescent tablet, moisture sensitive, ascorbic acid, direct compression, co-processed excipient.