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Magnesium Stearate
Interpretable artificial neural networks for retrospective QbD of pharmaceutical tablet…
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. Although artificial neural networks (ANNs) have emerged as powerful tools in data-rich environments, their…
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Avoiding N-nitrosodimethylamine formation in metformin pharmaceuticals by limiting dimethylamine and…
Since late 2019, concerns regarding trace levels of the probable human carcinogen N-dimethylnitrosamine (NDMA) in Metformin-containing pharmaceuticals have been an issue if they exceeded the maximum allowable intake of 96 ng/day for a medicine with long-term intake. Here, we report results from an…
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Upscaling of external lubrication from a compaction simulator to a rotary tablet press
External lubrication is a highly valuable alternative lubrication method as it minimizes the negative impact on tablet properties encountered when using internal lubrication. In current study, experiments were performed with automated external lubrication systems implemented in a compaction…
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COMBILOSE: A novel lactose-based co-processed excipient for direct compression
Lactose is the commonly used diluent in the manufacturing of tablets dosage form. However, the poor flowability and compressibility of lactose limit its use as a directly compressible filler binder. In this research work, composite excipient COMBILOSE was developed as a directly compressible filler…
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A Novel Approach of External Lubrication in a Rotary Tablet Press Using Electrostatics
Abstract
Purpose
In powder compaction on rotary tablet presses, the addition of a lubricant is normally mandatory. However, the typical internal lubrication method tends toward overlubrication, resulting in an alteration of the critical quality attributes of the product. In this study, the…
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Co-Crystallization Approach to Enhance the Stability of Moisture-Sensitive Drugs
Stability is an essential quality attribute of any pharmaceutical formulation. Poor stability can change the color and physical appearance of a drug, directly impacting the patient’s perception. Unstable drug products may also face loss of active pharmaceutical ingredients (APIs) and degradation,…
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Clarithromycin and Pantoprazole Gastro-Retentive Floating Bilayer Tablet for the Treatment of…
Bilayer/multilayer tablets have been introduced to formulate incompatible components for compound preparations, but they are now more commonly used to tailor drug release. This research aimed to formulate a novel gastro-retentive tablet to deliver a combination of a fixed dose of two drugs to…
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Screening of lubricants towards their applicability for external lubrication
Internal lubrication is associated with decreasing tensile strength and prolonged disintegration. These effects can be minimized using external lubrication. In current study, six lubricants (magnesium stearate, sodium stearyl fumarate, stearic acid, glyceryl dibehenate, poloxamer 188 and sucrose…
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Formulation-dependent stability mechanisms affecting dissolution performance of directly compressed…
During drug product development, stability studies are used to ensure that the safety and efficacy of a product are not affected during storage. Any change in the dissolution performance of a product must be investigated, as this may indicate a change in the bioavailability. In this study, three…
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Tablet formulation with dual control concept for efficient colonic drug delivery
Aim of this study was to develop a tablet formulation for targeted colonic drug release by implementing two control mechanisms: A pH-sensitive coating layer based on Eudragit® FS 30 D to prevent drug release in the upper gastrointestinal tract, combined with a matrix based on plant-derived…
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