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
Update: Risk Mitigation of Nitrosamines Formation in Drug Products: Role of Excipients
1. Introduction
The issue of Nitrosamine impurities in drug and excipient manufacturing has become a significant concern for the pharmaceutical industry and health authorities. In June 2018, the FDA was notified of the presence of N-nitrosodimethylamine (NDMA), an impurity found in valsartan, an…
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Opportunities and Challenges: Process Raman for the Real-Time Release Testing (RTRT) of…
Abstract
The use of a process analytical technology has been demonstrated using near-infrared spectroscopy for continuous manufacturing of pharmaceutical formulations and is within the scope of the U.S. Food and Drug Administration's real-time release testing initiative. While effective for simple…
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Selection of lubricant type and concentration for orodispersible tablets
Abstract
Lubricants are essential for most tablet formulations as they assist powder flow, prevent adhesion to tableting tools and facilitate tablet ejection. Magnesium stearate (MgSt) is an effective lubricant but may compromise tablet strength and disintegratability. In the design of…
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Elucidation of processing parameters for the reverse engineering of tablets
Abstract
Reverse engineering can assist in decoding the formula and manufacturing parameters employed in innovator formulations. Generic pharmaceutical industries use it to develop generic cheaper versions of innovator tablets. Herein, we report the systematic application of reverse engineering in…
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Beyond Tableting Lubrication – PRUV® by JRS Pharma
PRUV® by JRS Pharma is a tablet lubricant designed for formulations in which other lubricants lead to formulation and/or manufacturing challenges. As opposed to the frequently used lubricant, magnesium stearate, PRUV® offers the following advantages:
High degree of API compatibility*…
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Colon Drug Delivery Systems Based on Swellable and Microbially Degradable High-Methoxyl Pectin:…
Abstract
Oral colon delivery systems based on a dual targeting strategy, harnessing time- and microbiota-dependent release mechanisms, were designed in the form of a drug-containing core, a swellable/biodegradable polysaccharide inner layer and a gastroresistant outer film. High-methoxyl pectin was…
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Optimizing API Load and Minimizing Tablet Weight Leveraging an Innovative DC Mannitol
Presented at the 14th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical (PBP) Technology, 18 - 21 March 2024, Vienna, Austria:
INTRODUCTION
Tablets with stability issues often use mannitol, a stable, water-soluble excipient compatible with most drugs. Direct compression is a…
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Easy Tableting with Natural Disintegrants
Evaluation of a new disintegrant mixture from natural resources
Introduction
Tablet disintegration is most often required to divide a tablet into suitably small sub-units that facilitate achievement of the desired drug dissolution rate. While semi-synthetic or synthetic super-disintegrants are…
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Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet
An industrial case study of attempting to comply with EU regulation 2022/63
Recently, concerns have been raised about the safety of titanium dioxide (TiO2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the…
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Tableting behavior of freeze and spray-dried excipients in pharmaceutical formulations
Most of biopharmaceuticals, in their liquid form, are prone to instabilities during storage. In order to improve their stability, lyophilization is the most commonly used drying technique in the pharmaceutical industry. In addition, certain applications of biopharmaceutical products can be…
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