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Lactose
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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3D powder bed tablet printing: From a R&D printer to a scalable GMP printer
Powder bed-based 3D printing has been used to produce pharmaceutical tablets mainly under laboratory conditions. To advance the technology for commercial use, laboratory's proof of principles should be translated to and validated under good manufacturing practice (GMP) conditions. In this study,…
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Evaluation of the Effects of Storage Conditions on Spray-Dried siRNA-LNPs Before and after…
In an ideal world, pharmaceutical drugs would have infinite shelf life, no susceptibility to degradation, chemical reactions or loss of efficacy. In reality, these processes occur, however, making it desirable to extend a drugs’ shelf life. Nucleic acid-based drugs are most commonly stored as…
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Omega-3 fatty acid-based self-microemulsifying drug delivery system (SMEDDS) of pioglitazone:…
Pioglitazone (PGL) is an effective insulin sensitizer, however, side effects such as accumulation of subcutaneous fat, edema, and weight gain as well as poor oral bioavailability limit its therapeutic potential for oral delivery. Recent studies have shown that combination of both, PGL and fish oil…
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In-line particle size measurement during granule fluidization using convolutional neural…
This paper presents a machine learning-based image analysis method to monitor the particle size distribution of fluidized granules. The key components of the direct imaging system are a rigid fiber-optic endoscope, a light source and a high-speed camera, which allow for real-time monitoring of the…
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Spray drying robot for high-throughput combinatorial fabrication of multicomponent solid dispersions
During the development of pharmaceutical spray-dried formulations, many samples must be prepared for physico-chemical characterisation and dissolution testing by systematically varying parameters such as drug loading or the grades and ratios of excipients (polymers, surfactants, etc.). When spray…
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Process intensification using a semi-continuous mini-blender to support continuous direct…
The production of pharmaceutical tablets is shifting towards continuous manufacturing. Therefore, individual unit operations such as powder blending need to be re-designed. Continuous powder blending has been implemented successfully, but for low-dose formulations this is challenging due to…
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A tabletability change classification system in supporting the tablet formulation design via the…
In this paper, the material library approach was used to uncover the pattern of tabletability change and related risk for tablet formulation design under the roll compaction and dry granulation (RCDG) process. 31 materials were fully characterized using 18 physical parameters and 9 compression…
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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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A Machine Learning Approach to Qualitatively Evaluate Different Granulation Phases by Acoustic…
Wet granulation is a frequent process in the pharmaceutical industry. As a starting point for numerous dosage forms, the quality of the granulation not only affects subsequent production steps but also impacts the quality of the final product. It is thus crucial and economical to monitor this…
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