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Merck
Understanding the impact of mannitol on physical stability and aerosolization of spray-dried protein…
Abstract
Pulmonary delivery of protein-based therapeutics, including antibodies, is a promising option for treating respiratory diseases. Spray drying is a widely used method for producing dry powder formulations with mannitol being a commonly used excipient for these inhalation formulations. There…
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Liquid API Feeding in Pharmaceutical HME: Novel Options in Solid Dosage Manufacturing
Hot melt extrusion (HME) is a common unit operation. It is broadly applicable in the pharmaceutical industry and can be implemented in a continuous manufacturing line. However, the conventional way of active pharmaceutical ingredient (API) feeding with a pre-blend consisting of a powdered API and a…
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Interaction of thermal and rheological parameters critical for the processability of polyvinyl…
Purpose
Hot melt extrusion (HME) is a pivotal pharmaceutical manufacturing process employed to enhance the bioavailability of poorly soluble active pharmaceutical ingredients (APIs) in oral dosage forms. Often the applicability of the process is limited by the melt viscosity. The upper limit is…
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Nintedanib solid lipid nanoparticles improve oral bioavailability and ameliorate pulmonary fibrosis…
Nintedanib (NIN) and pirfenidone are the only approved drugs for the treatment of Idiopathic Pulmonary Fibrosis (IPF). However, NIN and pirfenidone have low oral bioavailability and limited therapeutic potential, requiring higher dosages to increase their efficacy, which causes significant liver and…
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PVA as binder in continuous twin-screw granulation
Introduction
Granulation of powder blends is a commonly applied technique for pharmaceutical formulations which have no suitable flowability or compactability or are inhomogeneous with regards to the API content. Mainly wet granulation is applied3 and here, especially continuous twin-screw…
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A pH-sensitive silica nanoparticles for colon-specific delivery and controlled release of catechin:…
Catechin is a naturally occurring flavonoid of the flavan-3-ol subclass with numerous biological functions; however, these benefits are diminished due to several factors, including low water solubility and degradation in the stomach's harsh environment. So, this study aimed to develop an intelligent…
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Monitoring low dose API blend uniformity with Parteck® M mannitol using near-infrared (NIR)…
Direct compression is often used for tablet manufacturing because it is the shortest, most effective, and least complex method. The physical properties of active pharmaceutical ingredients (APIs) can, however, create a challenge for flowability and compressibility, and, as a result, affect tablet…
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Reversible protein complexes as a promising avenue for the development of high concentration…
Abstract
High concentration formulations have become an important pre-requisite in the development of biological drugs, particularly in the case of subcutaneous administration where limited injection volume negatively affects the administered dose. In this study, we propose to develop high…
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How Low-in-Nanoparticulate-Impurities Sucrose Can Enable More Stable Protein Formulations
NANOPARTICULATE IMPURITIES IN PHARMACEUTICAL-GRADE SUCROSE
Nanoparticle impurities (NPIs) with a size of 100–300 nm have been discovered in pharmaceutical-grade sucrose (Weinbuch et al., 2015). These can lead to false analytical results, as they mimic protein aggregates and can thus cause the…
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Exploring Environmental Settings to Improve the Printability of Paroxetine-Loaded Filaments by Fused…
The successful integration of hot-melt extrusion (HME) and fused deposition modelling (FDM) depends on a better understanding of the impact of environmental conditions on the printability of formulations, since they significantly affect the properties of the raw materials, whose control is crucial…
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