The The Effect of concentration variable of croscarmellose superdisintegrant on tablet properties
DOI:
https://doi.org/10.60988/p.v38i2.128Keywords:
Croscarmellose sodium, Disintegration time, Hardness, FriabilityAbstract
Background:The incorporation of superdisintegrating agents in tablet formulations is to accelerate the disintegration time by affecting the release of the active ingredient from the tablet dosage form which in turn affects the drug onset of action in the body. Croscarmellose sodium possess characteristics which fulfill its action as a superdisintegrating agent with effects on other parameters including hardness and friability.
Aims: The aim of this research is to determine the effects of concentration variable of Croscarmellose sodium as a superdisintegrating agent on tablet dosage form critical quality attributes (CQA’s) including Disintegration time, Hardness and friability.
Material and methods: Three powder blends were prepared. Each blend constituting from poorly water soluble active pharmaceutical ingredient(API) in solid dispersion form, a filler, a Disintegrant and a lubricant. Three different tablet dosage form formulations were prepared (F1 (0.5% CCS), F2 (3% CCS), F3 (5% CCS)) as three test group formulations using the direct compression method. The prepared tablets then were tested for three Critical quality attributes (CQA’s) including Disintegration time, Hardness and friability in accordance to the United States pharmacopeia.
Results: The results of this study have shown that variations in the concentration of disintegrating agents have a different influence on the tested parameters of the tablets produced. The best disintegration time results were obtained in Formula 3, whereas highest tablet hardness and lowest friability percentage were obtained with Formula1. Conclusion: Increasing the concentration of Croscarmellose sodium in the tablet dosage form results in decreasing tablet disintegration time and hardness while increasing tablet friability.
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