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This work presents a system, where deep learning was used on images captured with a digital camera to simultaneously determine the API concentration and the particle size distribution (PSD) of two components of a powder blend. The blend consisted of acetylsalicylic acid (ASA) and calcium hydrogen phosphate (CHP), and the predicted API concentration was found corresponding with the HPLC measurements. The PSDs determined with the method corresponded with those measured with laser diffraction particle size analysis. This novel method provides fast and simple measurements and could be suitable for detecting segregation in the powder. By examining the powders discharged from a batch blender, the API concentrations at the top and bottom of the container could be measured, yielding information about the adequacy of the blending and improving the quality control of the manufacturing process. [Display omitted] [ABSTRACT FROM AUTHOR]

• An endoscopy-based direct imaging system can monitor granules during fluidization. • A convolutional neural network-based software was applied for particle detection. • In-line particle size measurement was accomplished despite dense particle flow. • The in-line measurements and off-line reference methods showed similar trends. This paper presents a machine learning-based image analysis method to monitor the particle size distribution of fluidized granules. The key components of the direct imaging system are a rigid fiber-optic endoscope, a light source and a high-speed camera, which allow for real-time monitoring of the granules. The system was implemented into a custom-made 3D-printed device that could reproduce the particle movement characteristic in a fluidized-bed granulator. The suitability of the method was evaluated by determining the particle size distribution (PSD) of various granule mixtures within the 100–2000 μm size range. The convolutional neural network-based software was able to successfully detect the granules that were in focus despite the dense flow of the particles. The volumetric PSDs were compared with off-line reference measurements obtained by dynamic image analysis and laser diffraction. Similar trends were observed across the PSDs acquired with all three methods. The results of this study demonstrate the feasibility of performing real‐time particle size analysis using machine vision as an in-line process analytical technology (PAT) tool. [Display omitted] [ABSTRACT FROM AUTHOR]

Recently, concerns have been raised about the safety of titanium dioxide (TiO 2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the food industry, and it is anticipated that the same will happen in the pharmaceutical industry. For this reason, pharmaceutical manufacturers have to consider the possible impact of removing TiO 2 from the film coating of tablets. In this paper, we present a case study of a commercially produced tablet where the film coating containing TiO 2 was replaced with a coating using calcium carbonate (CaCO 3) or with a transparent coating. The performance of the coatings was compared by measuring the moisture absorption rate and the dissolution profile of the tablets. In these regards, there were negligible differences between the coating types. The tablets contained a highly photosensitive drug, the ability of the coatings to protect the drug was evaluated through environmental stability and photostability measurements. The HPLC results showed that the inclusion of TiO 2 does not provide additional benefits, when humidity and thermal stress is applied, however its role was vital in protecting the drug from external light. There were several decomposition products which appeared in large quantities when TiO 2 was missing from the coating. These results imply that photosensitivity is an issue, replacing TiO 2 will be challenging, though its absence can be tolerated when the drug does not need to be protected from light. [Display omitted] [ABSTRACT FROM AUTHOR]