Babu Rekha’s scientific contributions

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Figure 2: Dissolution profile of Ezetimibe tablets in pH 7.0 Phosphate buffer with 0.2% SLS (Discriminatory media) (A) Different superdisintegrants at 3% concentration level; (B) Different grades of Crospovidone at 3% concentration level; (C) CP -A at different concentration levels.Since CP-A emerged as the more favorable disintegrant, it was decided to compare different grades of CP, from different manufacturers. Fig. 1B and 2B shows the dissolution profile of EZ tablets, in the recommended and the discriminatory media, respectively. The results clearly demonstrate the superiority of CP-A to enhance the release of the drug both in the recommended and more so even in the discriminatory medium. The reason could be due to the morphology of the different grades used of CP, used in the study. The SEM photomicrographs of the different grades of CP are shown in Fig. 3. From SEM it was observed that the surface morphology and particle shapes of various grades of CP differed. In general, they appeared to be fused aggregates of smaller particles resulting in highly porous sponge like structures. CP-B has bigger and more porous particles than its equivalent CP-C (Kollidon CL) and CP-D
PHYSICOCHEMICAL CHARACTERISTICS OF EZETIMIBE TABLETS PREPARED
ROLE OF TYPE AND CONCENTRATION OF SUPERDISINTEGRANTS ON IMMEDIATE RELEASE TABLETS OF EZETIMIBE
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February 2021

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1 Citation

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Babu Rekha

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A M J Newton

The purpose of the study was to investigate the role of type and concentration of superdisintegrants on immediate release tablets of ezetimibe. Tablets of Ezetimibe were prepared using superdisintegrants like Croscaramellose sodium (CCS), Sodium starch glycollate (SSG) and Crospovidone (CP) by wet granulation process. Further, tablets were also prepared with different concentrations of crospovidone and also with different grades of crospovidone, from different manufacturers. The prepared tablets were evaluated for their physico chemical properties and the in-vitro dissolution of the prepared tablets was conducted using the USFDA recommended dissolution medium and a discriminatory medium developed in-house. T80% values were indicative of faster drug release from tablet formulations containing CP in both the media. Out of the different grades of CP studied, polyplasdone XL-10 improved the dissolution rate in both the media and the concentration of Polyplasdone XL-10 impacted only the initial release rate in both the media. Stability study on tablets prepared with 3% Polyplasdone XL-10 showed that there was no difference in both rate and extent of drug released between initial and sixth month sample.Immediate release tablets of EZ with high dissolution rate were obtained with Polyplasdone XL-10 as a disintegrant, at 3% level.

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