Intrinsic Dissolution Rate (IDR) of Polyols

Pharmaceutically applicable polyols are represented different chemical structure and different solubility in aqueous media. Polyols used as a diluent for manufacturing of tablets and influence the dissolution of API, disintegration of tablets, and then effect on the bioavailability of immediate-released polyol-contained tablets. Thus, the intrinsic dissolution rate (IDR) of polyols is important and should be considered upon formation development.

Thus, project-related samples of commercially available polyols (such as xylitol, sorbitol, isomalt, mannitol) and polyvinylpyrrolidone were characterized with intrinsic dissolution rate using a USP II paddle apparatus. The calculated IDRs were organized in a dataset. Method. Cylindrical samples of polyols (D=25mm) were prepared using a vacuum compression molding (VCM) device (MeltPrep GmbH, Graz, Austria) by melting the polyols to obtain a nonporous flat surface. The tablets were coated with an Eudragit RS PO solution (30% w/v in acetone), leaving one round side (4.91 cm2) uncoated to be exposed to the dissolution medium. To prevent floating during the test, the tablets were attached to a coin. The cylindrical polyol samples were tested in 100 mL of 0.1 N HCl solution at 37 ± 0.5 ℃ using a Chinese Small Volume (CSV) Dissolution vessel with USP II paddle apparatus (ATS Xtend™, SOTAX AG, Allschwil, Switzerland) at 100 rpm. Aliquot samples (1 mL) were manually collected at required time-points. The concentration of dissolved polyols was determined spectrophotometrically using an Abbemat 350 Performance Plus refractometer (Anton Paar OptoTec GmbH, Seelze-Letter, Germany) at a wavelength of 589 nm based on the preliminary built calibration curves in 0.1 N HCl solution.

Data. The data in the form of CSV spreadsheets: calculation of intrinsic dissolution rate of specific polyol grades (file name: IDR_data.csv); calibration curve for each polyol (file name: IDR_calibration curve_data.csv). To perform the hardware setting, figures of dissolution test were presented in a graphical format (file name: IDR_hardward_settings.jpg), and representative video for sample was composed/presented too (file name: IDR_hardward_settings.mp4).