Unraveling the complexity of amorphous solid as direct ingredient for conventional oral solid dosage form: The story of Elagolix Sodium.

Conventional solid oral dosage form development is not typically challenged by reliance on an amorphous drug substance as a direct ingredient in the drug product, as this may result in product development hurdles arising from process design and scale-up, control of physical quality attributes, drug product processability and stability. Here, we present the Chemistry, Manufacturing and Controls development journey behind the successful commercialization of an amorphous drug substance, Elagolix Sodium, a first-in-class, orally active gonadotropin-releasing hormone antagonist. The reason behind the lack of crystalline state was assessed via Molecular Dynamics (MD) at the molecular and inter-molecular level, revealing barriers for nucleation due to prevalence of intra-molecular hydrogen bond, repulsive interactions between active pharmaceutical ingredient (API) molecules and strong solvation effects.

A Survey of Deep Learning Techniques for Underwater Image Classification.

In recent years, there has been an enormous interest in using deep learning to classify underwater images to identify various objects, such as fishes, plankton, coral reefs, seagrass, submarines, and gestures of sea divers. This classification is essential for measuring the water bodies' health and quality and protecting the endangered species. Furthermore, it has applications in oceanography, marine economy and defense, environment protection, underwater exploration, and human-robot collaborative tasks.

Control Strategies for Drug Product Continuous Direct Compression-State of Control, Product Collection Strategies, and Startup/Shutdown Operations for the Production of Clinical Trial Materials and Commercial Products.

Continuous manufacturing (CM) has emerged in the pharmaceutical industry as a paradigm shift with significant advantages related to cost, efficiency, flexibility, and higher assurance of quality. The inherent differences from batch processes justify examining the CM control strategy more holistically. This article describes the current thinking for the control and implementation of CM, using the example of a direct compression process and taking into consideration the ICH Q10 definition of "state of control" and process validation requirements.

Diabetes mellitus and renal tubular acidosis in primary Sjögren's syndrome.

Sjögren's syndrome is an autoimmune disease with multisystem involvement characterised by lymphocytic infiltration of exocrine glands resulting in keratoconjunctivitis sicca, xerostomia and bilateral parotid gland enlargement. Renal manifestation is characteristically chronic lymphocytic tubulointerstitial nephritis. Diabetes mellitus in Sjogren's syndrome has also been described in literature.