Published October 31, 2022 | Version https://impactfactor.org/PDF/IJPCR/14/IJPCR,Vol14,Issue10,Article52.pdf
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In-Vitro Bioequivalence Studies of Commercialized Vildagliptin Tablets in India

Description

The objective of this work is to evaluate the in-vitro behavior of marketed vildagliptin tablets. Six marketed Vildagliptin tablets and the innovator were evaluated. Physicochemical parameters such as percentage weight deviation, hardness, friability, drug content, disintegration, dissolution, similarity factor and difference factors were analyzed as per IP.  Dissolution profiles were evaluated using USP apparatus type 2 at 50 rpm and 900 ml of phosphate buffer in pH 6.8.  All the marketed products under study were bioequivalent to the innovator.  B-2 & B4 showed least similarity values and highest difference factor values but lies within the acceptable range.  B-6 showed the highest similarity value and least difference factor value with that of the innovator product. The results indicate that at pH 6.8 all marketed vildagliptin tablets included in this study seem to have good overall quality with good dissolution rate when compared to that of innovator product.

 

 

 

Abstract (English)

The objective of this work is to evaluate the in-vitro behavior of marketed vildagliptin tablets. Six marketed Vildagliptin tablets and the innovator were evaluated. Physicochemical parameters such as percentage weight deviation, hardness, friability, drug content, disintegration, dissolution, similarity factor and difference factors were analyzed as per IP.  Dissolution profiles were evaluated using USP apparatus type 2 at 50 rpm and 900 ml of phosphate buffer in pH 6.8.  All the marketed products under study were bioequivalent to the innovator.  B-2 & B4 showed least similarity values and highest difference factor values but lies within the acceptable range.  B-6 showed the highest similarity value and least difference factor value with that of the innovator product. The results indicate that at pH 6.8 all marketed vildagliptin tablets included in this study seem to have good overall quality with good dissolution rate when compared to that of innovator product.

 

 

 

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Additional details

Dates

Accepted
2022-10-08

References

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