Physicochemical characterization of five glyburide powders: A BCS based approach to predict oral absorption

Wei, Hai; Dalton, Chad; Maso, Marie Di; Kanfer, Isadore; Löbenberg, Raimar

doi:10.1016/j.ejpb.2008.01.026

Cited by 50 publications

(34 citation statements)

References 23 publications

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“…Figures 2 and 3, and Table IV show the correlation. In the (16) experimental study, the measured drug release was zero for the BFaSSIF, and the predicted data was 5.9%; therefore, no correlation was found for this media. The correlations between in vitro release in the experimental data and the predicted values including the P values are presented in Table IV.…”

Section: Resultsmentioning

confidence: 99%

“…The experimental data showed that increasing the pH increased the drug's solubility (16). Also, using solubilizing agent in the dissolution media…”

Section: Discussionmentioning

confidence: 99%

“…Apparatus type, instrument speed, medium volume, and medium type were used as specified from the study (15,16). In blank FaSSIF the solubility enhancement factor (SEF) of lecithin and sodium taurocholate was equal to 1; however, in FaSSIF the SEF was optimized for low quality FaSSIF and the dynamic pH change protocol as following: Lecithin SEF=1374.91; sodium taurocholate SEF=96200.54.…”

Section: Methodsmentioning

confidence: 99%

“…Published glyburide in vitro dissolution data was used for the simulations (15,16). For the purpose of this study, the reference product of the study was chosen because more information was available about this product.…”

Section: Methodsmentioning

confidence: 99%

“…As mentioned in the "Method" section, the input value was the same for the LQ and HQ FaSSIF media, and the results represent the setting in DDDPlus™ using the LQ-chemical grades of lecithin and sodium taurocholate. The experimental data for glyburide had shown that low quality FaSSIF was the best media to establish an in vivo/in vitro correlation (IVIVC) and was, therefore, used in this study only (15,16). In a quality by design (QbD) approach, dissolution should reflect ideally the in vivo product performance (17)(18)(19).…”

Section: Percent Of Particles Distributionmentioning

confidence: 99%

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Simulation of In Vitro Dissolution Behavior Using DDDPlus™

et al. 2014

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Abstract. Dissolution testing is a performance test for many dosage forms including tablets and capsules. The objective of this study was to evaluate if computer simulations can predict the in vitro dissolution of two model drugs for which different dissolution data were available. Published montelukast sodium and glyburide dissolution data was used for the simulations. Different pharmacopeial and biorelevant buffers, volumes, and rotations speeds were evaluated. Additionally, a pH change protocol was evaluated using these buffers. DDDPlus™ 3, Beta version (Simulation Plus, Inc.), was used to simulate the in vitro dissolution data. The simulated data were compared with the in vitro data. A regression coefficient between predicted and observed data was used to assess the simulations. The statistical analysis of Montelukast sodium showed that there was a significant correlation between the in vitro release data and the predicted data for all cases except for one buffer. For glyburide, there was also a significant correlation between the experimental data and the predicted data using single pH conditions. Using the dynamic pH protocol, a correlation was significant for one biorelevant media. The simulations showed that both in vitro drug releases were sensitive to solubility effects which confirmed their BCS class II category. Computer simulations of the in vitro release using DDDPlus™ have the potential to estimate the in vivo dissolution at an early stage in the drug development process. This might be used to choose the most appropriate dissolution condition to establish IVIVC and to develop biorelevant in vitro performance tests to capture critical product attributes for quality control procedures in quality by design environments.

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Section: Resultsmentioning

confidence: 99%

“…The experimental data showed that increasing the pH increased the drug's solubility (16). Also, using solubilizing agent in the dissolution media…”

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%