Lenz, Jan, Bunjes, Heike, Kwade, Arno and Juhnke, Michael (2021) An Improved Method for the Simultaneous Determination of Water Uptake and Swelling of Tablets. International journal of pharmaceutics, 595 (n/a). p. 120229. ISSN 1873-3476; 0378-5173

Abstract

Water uptake and swelling are processes occurring during active pharmaceutical ingredient (API) dissolution from tablets. Thereby, disintegration is promoted and the enhanced exposure of API surface area to the dissolution medium facilitates API dissolution. A method for the simultaneous determination of time-resolved water uptake and swelling of round flat-faced tablets was introduced, where the water penetrated the tablets through their front face. The water uptake was measured gravimetrically and swelling was detected by a digital camera. An algorithm for the symmetry-based 3D volume reconstruction (SVR) was applied to obtain volumes of the tablets from 2D images. Inert porous ceramic test specimens were employed to repeatedly perform real-time water uptake measurements for the validation of the gravimetrical analysis. Using the inert test specimens a precision within 6 % towards the end of the analysis and an accuracy within 6.3 % deviation were identified. X-ray micro-CT technique (µ-CT) was used to validate the accuracy of the SVR, where the determined volumes were in good accordance within 6.1 % deviation. A case study with binary formulations of microcrystalline cellulose (MCC, filler), and croscarmellose sodium (CCS, disintegrant) or sodium starch glycolate (SSG, disintegrant), proved reproducibility, as well as the ability to discriminate formulation characteristics, such as disintegrant type, composition and porosity for water uptake and swelling with the necessary time resolution.

Item Type:	Article
Date Deposited:	13 Feb 2021 00:45
Last Modified:	13 Feb 2021 00:45
URI:	https://oak.novartis.com/id/eprint/42747