High throughput in-line content uniformity measurement of tablets based on real-time UV imaging.

This paper presents a precursor of a novel, high-throughput, in-line system, which utilizes ultraviolet (UV) imaging in order to predict the active pharmaceutical ingredient (API) content of tablets in real-time, non-destructive manner. Pimobendan, cardiovascular drug used in veterinary medicine was chosen as a fluorescent model API. Two experiments were carried out using different measurement setups, where the tablets were moving at different speeds.

Shape Memory Characteristics of Injection Molded Poly(lactic acid) Multiscale Hybrid Composites.

In this study, we showed that hybrid reinforcement-a combination of nanoparticles and fibers-can provide more effective reinforcement for increasing the recovery stress of a shape memory polymer (SMP) than using either filler individually. We mixed carbon fibers (CF) and carbon nanotubes (CNT) into a poly(lactic acid) (PLA) matrix on a twin-screw extruder and injection molded specimen from the hybrid composite. Subsequently, some of the specimens were subjected to crystallizing heat treatment, while others were kept as molded to study the effects of crystallinity as well.

The European Nucleotide Archive in 2024.

The European Nucleotide Archive (ENA, https://www.ebi.ac.

Development of Innovative Electrospun Nepafenac-Loaded Nanofibers-based Ophthalmic Inserts.

Electrospun nanofibers can be utilized to develop patient-centric ophthalmic formulations with reasonable bioavailability at the targeted site. The current study aimed to develop 0.1% w/w of nepafenac-loaded electrospun nanofibrous webs as potential candidates for ocular delivery of nepafenac with improved solubility and stability.

Automated tablet defect detection and the prediction of disintegration time and crushing strength with deep learning based on tablet surface images.

This paper presents novel measurement methods, where deep learning was used to detect tableting defects and determine the crushing strength and disintegration time of tablets on images captured by machine vision. Five different classes of defects were used and the accuracy of the real-time defect recognition performed with the deep learning algorithm YOLOv5 was 99.2 %.

Enhanced surface activation of ground tire rubber via the radiolysis of water for effective rubber recycling.

In this study, we examined the chemical changes occurring in ground tire rubber (GTR) and on its surface as a result of gamma irradiation in water, with low doses of 5, 10, 15, 20, 25, and 30 kGy. To better distinguish the changes the radiation caused in the GTR and the surface activation of the GTR caused by the irradiated water, we also performed radiation treatments in an inert atmosphere. We mixed the treated GTRs with fresh rubber, and after vulcanization, investigated the mechanical properties and conducted dose optimization.

Formulation and Development of Nanofiber-Based Ophthalmic Insert for the Treatment of Bacterial Conjunctivitis.

A novel ophthalmic delivery system utilizing levofloxacin-loaded, preservative-free, nanofiber-based inserts was investigated. Polyvinyl alcohol (PVA) and Poloxamer 407 (Polox)were employed as matrix materials, while hydroxypropyl-beta-cyclodextrin (HP-β-CD) was a solubilizer. The formulations were prepared via electrospinning and characterized for fiber morphology, drug dissolution, cytotoxicity, and antimicrobial activity.

Development and Evaluation of Different Electrospun Cysteamine-Loaded Nanofibrous Webs: A Promising Option for Treating a Rare Lysosomal Storage Disorder.

Nanofibers can be utilized to overcome the challenges faced by conventional ophthalmic formulations. This study aimed to develop and characterize cysteamine (Cys)-loaded nanofiber-based ophthalmic inserts (OIs) as a potential candidate for the treatment of ophthalmic cystinosis using water-soluble polyvinyl alcohol (PVA)/poloxamer 407 (PO-407) and water-insoluble tetraethoxysilane (TEOS)/PVA nanofibers. Plain and Cys-loaded fibers in different proportions were prepared by the electrospinning method and studied for their morphological, physicochemical, release study, cytocompatibility effects, and stability study.

Real-time release testing of in vitro dissolution and blend uniformity in a continuous powder blending process by NIR spectroscopy and machine vision.

Continuous manufacturing is gaining increasing interest in the pharmaceutical industry, also requiring real-time and non-destructive quality monitoring. Multiple studies have already addressed the possibility of surrogate in vitro dissolution testing, but the utilization has rarely been demonstrated in real-time. Therefore, in this work, the in-line applicability of an artificial intelligence-based dissolution surrogate model is developed the first time.

UV-VIS imaging-based investigation of API concentration fluctuation caused by the sticking behaviour of pharmaceutical powder blends.

Surface powder sticking in pharmaceutical mixing vessels poses a risk to the uniformity and quality of drug formulations. This study explores methods for evaluating the amount of pharmaceutical powder mixtures adhering to the metallic surfaces. Binary powder blends consisting of amlodipine and microcrystalline cellulose (MCC) were used to investigate the effect of the mixing order on the adherence to the vessel wall.

Estimands in CNS trials - A review of strategies for addressing intercurrent events.

Background: The estimands framework represents a significant innovation for the design, conduct, analysis, and interpretation of clinical trials. An aim of the framework is to increase precision and transparency on the handling of intercurrent events (IEs), defined as events occurring after treatment initiation and affecting the endpoint. While the experience in constructing and reporting estimands in the published literature is limited, developers performing confirmatory studies are already making use of the new paradigm, allowing to survey the strategies proposed by applicants and endorsed by regulators.

Sobetirome rescues α-synuclein-mediated demyelination in an in vitro model of multiple system atrophy.

Multiple system atrophy (MSA) is a rare and rapidly progressive atypical parkinsonian disorder characterized by oligodendroglial cytoplasmic inclusions containing α-synuclein (α-syn), demyelination, inflammation and neuronal loss. To date, no disease-modifying therapy is available. Targeting α-syn-driven oligodendroglial dysfunction and demyelination presents a potential therapeutic approach for restricting axonal dysfunction, neuronal loss and disease progression.

The European Nucleotide Archive in 2023.

The European Nucleotide Archive (ENA; https://www.ebi.ac.

Developing medicines for the pre-symptomatic stage of degenerative neurological conditions: Challenges and opportunities.

Neurodegenerative disorders have a devastating disease course and an increasing prevalence due to prolonged life expectancy. In the last decades, it has become increasingly clear that these diseases often start much earlier, before the onset of symptoms, creating a potential window for pre-symptomatic treatment, a strategy that is desirable from both the biologic and the ethical point of view. However, studying treatments for a pre-symptomatic population presents objective difficulties.

Convolutional neural network-based evaluation of chemical maps obtained by fast Raman imaging for prediction of tablet dissolution profiles.

In this work, the capabilities of a state-of-the-art fast Raman imaging apparatus are exploited to gain information about the concentration and particle size of hydroxypropyl methylcellulose (HPMC) in sustained release tablets. The extracted information is utilized to predict the in vitro dissolution profile of the tablets. For the first time, convolutional neural networks (CNNs) are used for the processing of the chemical images of HPMC distribution and to directly predict the dissolution profile based on the image.

AI-based analysis of in-line process endoscope images for real-time particle size measurement in a continuous pharmaceutical milling process.

This paper presents a case study on the first in-line application of AI-based image analysis for real-time pharmaceutical particle size measurement in a continuous milling process. An AI-based imaging system, which utilises a rigid endoscope, was tested for the real-time particle size measurement of solid NaCl powder used as a model API in the range of 200-1000 µm. After creating a dataset containing annotated images of NaCl particles, it was used to train an AI model for detecting particles and measuring their size.

Combined effects of plasticizers and D-lactide content on the mechanical and morphological behavior of polylactic acid.

Nowadays, research into environmentally friendly, renewable materials is the focus of materials science. One of the best candidates for these purposes is polylactic acid (PLA), whose properties are determined mainly by its D-lactide content. PLA is often plasticized to achieve proper toughness.

Interpretable artificial neural networks for retrospective QbD of pharmaceutical tablet manufacturing based on a pilot-scale developmental dataset.

As the pharmaceutical industry increasingly adopts the Pharma 4.0. concept, there is a growing need to effectively predict the product quality based on manufacturing or in-process data.

Nanofiber formation as a promising technology for preservation and easy storage of extracellular vesicles.

Extracellular vesicles (EVs) are cell-derived, membrane-enclosed particles with the potential for a wide range of future therapeutic applications. However, EVs have almost always been administered by direct injection, likely hindering their efficacy because of rapid clearance from the injection site. The present study aimed to incorporate medium-sized extracellular vesicles (mEVs) into fast-dissolving electrospun polyvinylpyrrolidone-based nanofibers to explore the storage-dependent structure-activity relationship of the resulting nanofibrous formulations.

Tc‑labeled single-domain antibody for SPECT/CT assessment of HER2 expression in diverse cancer types.

Unlabelled: The expression status of human epidermal growth factor receptor 2 (HER2) in cancer predicts response to HER2-targeted therapy. Therefore, its accurate determination is of utmost importance. In recent years, there has been an increase in research on noninvasive techniques for molecular imaging, as this method offers the advantages of a more accurate determination of HER2 status without the need for multiple biopsies.

Development of electrically conductive hybrid composites with a poly(lactic acid) matrix, with enhanced toughness for injection molding, and material extrusion-based additive manufacturing.

In this study, we developed electrically conductive nano- and hybrid composites with a poly(lactic acid) (PLA) matrix for different melt processing technologies. We used short carbon fiber and multi-walled carbon nanotube reinforcements to enhance electric conductivity. We prepared the composite compounds with twin-screw extrusion; then the compounds were processed via injection molding and fused filament fabrication.