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Lactose
3D Printing Technology: A New Approach for the Fabrication of Personalized and Customized…
3DP is a computer-aided design with the interesting innovation of prototyping layer-by-layer, creating 3D articles as digital blueprints to accomplish unequaled gracefulness, time protection, and extraordinary assembling ability of pharmaceutical dosage forms. 3D printing technology offers a novel…
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Engineering artesunate-loaded micelles using spray drying for pulmonary drug delivery
Novel d-α-tocopheryl polyethylene glycol 1000 succinate (TPGS) micelles containing the anti-cancer drug artesunate (ART) were developed in a dry powder form for inhalation for the treatment of lung cancer. Targeted delivery to the lungs via inhalation presents a challenge, and the current study…
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Risk Mitigation of Nitrosamines Formation in Drug Products: Role of Excipients
1. Introduction
The issue of Nitrosamine impurities in drug and excipient manufacturing has become a significant concern for the pharmaceutical industry and health authorities. In June 2018, the FDA was notified of the presence of N-nitrosodimethylamine (NDMA), an impurity found in valsartan, an…
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Integrated continuous melt granulation-based powder-to-tablet line: process investigation and…
In the last decades, continuous manufacturing (CM) has become a research priority in the pharmaceutical industry. However, significantly fewer scientific researches address the investigation of integrated, continuous systems, a field that needs further exploration to facilitate the implementation of…
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Planetary roller melt granulation (PRMG) – A new continuous method for powder processing
Abstract
For the continuous operation of granulation, which is a standard unit operation in powder processing to modify the particle size, the use of twin-screw machines was established as standard method for wet and melt granulation over the last decade. A main characteristic for this technology…
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Deep Learning-Based Machine Vision System for Use in High-Shear Granulation
Aim
Develop a prototype machine vision system and evaluate feasibility of a deep learning-based image analysis approach for estimation of the state of granulation on the acquired granule bulk surface images.
Introduction
Despite many decades of research in granulation technology, the…
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Development of a Discriminative Dissolution Method, Using In-Silico Tool for Hydrochlorothiazide and…
Hydrochlorothiazide (HTZ) and Valsartan (VAL) are poorly soluble drugs in BCS classes IV and II. This study aimed to develop a method to assess the dissolution profile of tablets containing HTZ (12.5 mg) and VAL (160 mg) as a fixed-dose combination, using in silico tools to evaluate products…
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Novel Bioequivalent Tablet of Solifenacin Succinate Prepared Using Direct Compression Technique for…
Abstract
We designed a bioequivalent tablet form of solifenacin succinate (SOL) with an improved storage stability using a direct compression (DC) technique. An optimal direct compressed tablet (DCT) containing an active substance (10 mg), lactose monohydrate, and silicified microcrystalline…
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A multi-step machine learning approach for accelerating QbD-based process development of protein…
This study proposes a new material-efficient multi-step machine learning (ML) approach for the development of a design space (DS) for spray drying proteins. Typically, a DS is developed by performing a design of experiments (DoE) with the spray dryer and the protein of interest, followed by deriving…
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At-line porosity sensing for non-destructive disintegration testing in immediate release tablets
Fully automated at-line terahertz time-domain spectroscopy in transmission mode is used to measure tablet porosity for thousands of immediate release tablets. The measurements are rapid and non-destructive. Both laboratory prepared tablets and commercial samples are studied. Multiple measurements on…
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