Publications by authors named "Venkat Tumuluri"

The objective of the study was to predict pharmacokinetic (PK) and pharmacodynamic (PD) parameters of matrix-based modified release (MR) drug product of vildagliptin. Physiologically based biopharmaceutics modeling (PBBM) was developed using GastroPlus™ based on the available data including immediate-release (IR) drug product of vildagliptin. In vitro-in vivo correlation (IVIVC) was developed using mechanistic deconvolution to predict plasma concentration-time profile and PK parameters for a MR drug product planned for clinical use.

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The objective of this study was to investigate the use of Raman spectroscopy for the quantitative and qualitative analysis of an active ingredient in hot-melt extruded film formulations. Clotrimazole and ketoprofen were used as the active pharmaceutical ingredients (APIs) in the subject formulations. Films were prepared with contents varying from 1 to 20% of the respective API.

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Samples of magnesium stearate monohydrate and dihydrate were used to prepare standard mixtures of known pseudopolymorphic composition. Near infrared spectra (NIR) of the standard mixtures were measured to develop multivariate calibration models for the pseudopolymorphic composition of magnesium stearate by partial least squares (PLS) regression. Magnesium stearate hydrate compositions of the standard mixtures were compared against the hydrate composition based on thermogravimetric analysis (TGA).

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