Magnesium stearate, also known as magnesium octadecanoate, is a common additive used in the pharmaceutical industry. It is a white, odorless, and tasteless powder that is highly insoluble in water, but soluble in organic solvents.
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Magnesium Stearate
Evaluation of In-Die Compression Data for a Deeper Understanding of Altered Excipient Properties…
The thermodynamic analysis of tablet formation includes the thermal and mechanical analysis during compression. The aim of this study was to evaluate alterations of force–displacement data upon temperature rise as an indicator for changed excipient properties. The tablet press was equipped with a…
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Effects of Additives on the Physical Stability and Dissolution of Polymeric Amorphous Solid…
Polymeric amorphous solid dispersion (ASD) is a popular approach for enhancing the solubility of poorly water-soluble drugs. However, achieving both physical stability and dissolution performance in an ASD prepared with a single polymer can be challenging. Therefore, a secondary excipient can be…
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Simulation of roller compaction by combination of a compaction simulator and oscillating mill – A…
This study investigates the feasibility of a compaction simulator and oscillating mill to mimic a roller compactor as a material sparing approach for process development. Microcrystalline cellulose and dicalcium phosphate dihydrate were selected to represent soft and hard materials, respectively.…
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Digital Compounding in Pharmacies: A Pilot Stability Study †
The manufacture of medicines on demand for a particular patient, at the point of care, may be achieved via 3D printing, improving therapeutic outcomes, medication adherence and patient safety. Tablets are often printed using a combination of hot-melt extrusion and fused deposition modelling. In this…
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Development of extended-release formulations containing cyclobenzaprine based on physiologically…
The use of physiologically based biopharmaceutics modeling (PBBM) and bioequivalence safe space is increasingly common for immediate-release drug products. However, for extended-release (ER) formulations there are only a few examples of this application. In this study, we developed ER formulations…
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Impact of Raman Mapping Area and Intra-Tablet Homogeneity on the Accuracy of Sustained-Release…
This exploratory study investigated the minimum required Raman mapping area for predicting sustained-release tablet dissolution profiles based on intra-tablet homogeneity. The aim was to minimize scanning time while achieving reliable dissolution profile predictions. To construct the sample set, we…
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Factors That Influence Sustained Release from Hot-Melt Extrudates
Hot-melt extrusion is a well-established tool in the pharmaceutical industry, mostly implemented to increase the solubility of poorly soluble drugs. A less frequent application of this technique is to obtain formulations with extended release. This study investigated the influence of polymer choice,…
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Effect of process parameters in high shear granulation on characteristics of a novel co-processed…
In this study, insights into the development and optimization of a co-processed excipient based on mesoporous silica are presented. The main advantage of such a material is that it is appropriate for direct tablet compression and has a sufficiently large specific surface area to be suitable for…
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Modeling the Impact of Excipients Selection on Nitrosamine Formation towards Risk Mitigation
Abstract
Risk control for nitrosamine impurities in drug products is currently a major challenge in the industry. Nitrosamines can form during drug product manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities. The level of nitrites in excipients and…
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Study of direct compression coverage in view of design space – Ceolus UF grades
1. What is the design space?
The design space (DS) is a multidimensional combination and interaction of input variables (e.g., properties of raw materials) and process parameters that have been proven to ensure the quality of drug products. Operation within the DS is not considered a change,…
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