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DFE Pharma
Attribute transmission and effects of diluents and granulation liquids on granule properties and…
This study aims to examine (i) the effect of diluent types (lactose monohydrate, corn starch, and microcrystalline cellulose) and granulation liquids (20% polyvinylpyrrolidone K30, 65% alcohol, and dispersion containing 40% model drug– Pithecellobium clypearia Benth extracted powder) on granule…
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Exploring the influence of magnesium stearate content and mixing modality on the rheological…
Since carrier-based dry powder inhalers (DPIs) suffer from inadequate drug deposition in the lung, an increasing number of marketed products have added magnesium stearate (MgSt) to improve the aerosolization, dispersion, and stability against moisture of DPI. However, for carrier-based DPI, there is…
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Effect of batch-to-batch variation of spray dried lactose on the performance of feeders
With the emergence of quality by design (QbD), it becomes imperative to gain understanding of the impact of batch-to-batch variability of raw materials on the performance of processes. Feeding is the first unit of operation in a continuous manufacturing line and is critical for the final product…
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Comparing failure tests on pharmaceutical tablets: Interpretation using experimental results and a…
The mechanical strength is an important quality attribute of pharmaceutical tablets. It can be determined using different failure tests like the Brazilian test or the three-point bending test. Nevertheless, literature shows that different failure tests often give conflicting values of tensile…
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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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3D screen printing technology enables fabrication of oral drug dosage forms with freely tailorable…
3D printing offers new opportunities to customize oral dosage forms of pharmaceuticals for different patient populations, improving patient safety, care, and compliance. Although several notable 3D print technologies have been developed, such as inkjet printing, powder-based printing, selective…
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The impact of material chemistry and morphology on attrition behavior of excipients during high…
Particle breakage by attrition is unavoidable in some unit operations and can lead to uncontrolled behavior of materials during processing. The aim of this study is to clarify the impact of material properties on attrition behavior. For the first time, an integral study with varying morphologies and…
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The application of Near-Infrared Spatially Resolved Spectroscopy in scope of achieving continuous…
In scope of achieving real-time release of tablets, quality attributes need to be monitored and controlled through Process Analytical Technology tools such as near-infrared spectroscopy (NIRS). The authors evaluated the suitability of NIR-Spatially Resolved Spectroscopy (NIR-SRS) for continuous…
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Impact of material properties and process parameters on tablet quality in a continuous direct…
The current paper shows how excipient properties impact the process parameters and the final tablet properties in a fully integrated continuous direct compression line. Blend properties of low-dose (1% w/w) and high-dose (40% w/w) paracetamol formulations were evaluated and linked to the blending …
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Smart specification setting for dry powder inhalation carriers
The specifications of excipients are important to pharmaceutical manufacturers to ensure that the final product can be manufactured robustly over the entire lifecycle of a drug product. Particle size specifications are key for dry powder inhalation excipients and they should be agreed between users…
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