Browsing Category
Continuous manufacturing
A universal digital control concept for end-to-end manufacturing
Abstract
With the implementation of advanced manufacturing concepts (e.g., continuous operation, integration of different process routes and modular manufacturing), control of the process and the related product quality becomes more complex. Unlike traditional in-process controls and end-product…
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Comparative analysis of tablet dissolution behavior: Batch vs. Continuous direct compression
Abstract
Continuous manufacturing offers advantages over traditional batch methods, including agility, efficiency, and sustainability. However, transitioning to continuous manufacturing in process development is challenging due to the need for early adoption of industrial-scale equipment.…
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Hot Melt Extrusion as Continuous Manufacturing Technique to Produce Bilayer Films Loaded with…
Abstract
Background/Objectives: The oral delivery of large-molecule drugs remains challenging due to poor solubility, perdemeability, and stability in the gastrointestinal tract, resulting in low bioavailability. In this study, hot melt extrusion (HME) was investigated as a solvent-free…
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Optimizing Continuous Feeding of Poorly Flowing Excipients: Impact of Batch-To-Batch Variability and…
Purpose
Understanding batch-to-batch variation of excipients and correlating this to process performance is a key concept of Quality-by-Design for pharmaceutical product development. In this study, the effect of batch-to-batch variation in material properties of milled lactose monohydrate on…
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Evaluation of Calibration Burden for Monitoring of a Pharmaceutical Continuous Manufacturing Line…
Abstract
Process analytical technology (PAT) tools are an important part of process monitoring and control in pharmaceutical continuous manufacturing (CM) that help ensure product quality. However, there is hesitancy to adopt PAT due, in part, to the high start-up costs. A portion of the cost is…
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Methodology for rapid development of a continuous loss-in-weight feeding process
The pharmaceutical industry has been shifting towards continuous manufacturing, specifically for tablet production. Compared to batch processing, continuous tableting exhibits higher process efficiency, better process control, reduced footprint, and consistent product quality. Understanding mass…
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Investigation of aerosol jet printing for the preparation of solid dosage forms
Abstract
Oral drug delivery remains the preferred method of drug administration but due to poor solubility many active pharmaceutical ingredients (APIs) are ill suited to this. A number of methods to improve solubility of poorly soluble Biopharmaceutical Classification System (BCS) Class II drugs…
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The impact of glidant addition on the loss-in-weight feeding of active pharmaceutical ingredients
Abstract
In recent years, continuous manufacturing (CM) has become increasingly popular in the pharmaceutical industry for the production of oral solid dosage (OSD) forms. Most of the newly developed active pharmaceutical ingredients (APIs) nowadays are extremely cohesive and sticky with a mean…
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Determination of Ribbon Solid Fraction in Roll Compaction using Ibuprofen DC100
Abstract
Process Analytical Technology (PAT) plays a crucial role in the design of today’s manufacturing lines as continuous manufacturing becomes more important. Until now PAT tools to measure the ribbon solid fraction (SFribbon) in-line are not commonly used in roll compaction. The aim of this…
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For the good of the patient: Silica & Silicates from Evonik in the pharmaceutical industry
Many challenges – one solution: Fumed silica as well as precipitated silica and silicates from Evonik are some of the most important and highly utilized pharmaceutical excipients. Whether you manufacture medicines for solid, semi-solid or liquid dosing, we support you at every stage of product…
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