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Mallinckrodt
Your visit at CPHI worldwide 2022 in Frankfurt
CPHI worldwide opens its doors again. This year in Frankfurt at the Messe Frankfurt. In two weeks, from 1st to 3rd November, you can finally have a face-to-face chat with visitors and exhibitors again. As usual, InnoPack, P-MEC, FDF, ICSE and BioProduction will be held together with CPHI.
The…
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Manufacture of Tablets with Structurally-Controlled Drug Release using Rapid Tooling Injection…
With advancements in the pharmaceutical industry pushing more towards tailored medicines, novel approaches to tablet manufacture are in high demand. One of the main drivers towards micro-scale batch production is the ability to fine-tune drug release. This study demonstrates the use of rapid tooling…
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Continuous direct compression: Development of an empirical predictive model and challenges regarding…
In this study, an empirical predictive model was developed based on the quantitative relationships between blend properties, critical quality attributes (CQA) and critical process parameters (CPP) related to blending and tableting. The blend uniformity and API concentration in the tablets were used…
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Impact of Critical Material Attributes (CMAs)-Particle Shape on Miniature Pharmaceutical Unit…
The U.S. Food and Drug Administration (FDA) emphasizes drug product development by Quality by Design (QbD). Critical material attributes (CMAs) are a QbD element that has an impact on pharmaceutical operations and product quality. Pharmaceutical drugs often crystallize as needle-shaped (a CMA)…
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Delta-mannitol to enable continuous twin-screw granulation of a highly dosed, poorly compactable…
In current study, it was investigated if the moisture-mediated polymorphic transition from δ- to β-mannitol during twin screw granulation (TSG) also took place in high drug loaded formulations and if the specific granule morphology associated with the polymorphic transition could enable tableting of…
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A novel approach to support formulation design on twin screw wet granulation technology:…
The overall objective of this work is to understand how excipient characteristics influence the drug product quality attributes and process performance of a continuous twin screw wet granulation process. The knowledge gained in this study is intended to be used for Quality by Design (QbD)-based…
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