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Abstract Real-time release testing is defined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use...
Abstract The prediction of tablet dissolution from in-process data remains a key challenge in pharmaceutical manufacturing, as in vitro dissolution...
Abstract The assurance of pharmaceutical product quality, safety, and efficacy has historically relied on rigorous analytical standards, pharmacopoeial specifications, and...
Abstract This review is presented in two parts: Part I addresses the theoretical foundations and principles of ultrasonic and acoustic...
Abstract Background: Fused deposition modeling (FDM) is one of the most well-known and often published methods for 3D-printed drug delivery systems....
Abstract The increasing demand for nondestructive quantification of active pharmaceutical ingredients in low-dose formulations has highlighted the sensitivity limitations of...
Abstract Quality by design (QbD) and design of experiments (DoE) have become central to modern pharmaceutical development, yet most guidance...
Spin freeze-drying (SFD) has emerged as a potential breakthrough in pharmaceutical lyophilization. It promises over 90 % reductions in cycle time...
Amorphous solid dispersions (ASDs) enhance the solubility and bioavailability of drugs, yet their inherent instability and the risk of recrystallisation...
Abstract Purpose This study aims to develop an integrated control strategy using process analytical technology (PAT) and a quality by...
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