Pharma Excipients
Pellet
A Study on the Applicability of Multiple Process Analysers in the Production of Coated Pellets
Process analytical technology (PAT) has become an important factor in design, analysis and control of complex technological processes. In the present study, pellet coating process was monitored using four different PAT approaches, i.e. near-infrared (NIR) spectroscopy, Raman spectroscopy, in-line…
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Evaluation of in-line particle measurement with an SFT-probe as monitoring tool for process…
The Process Analytical Technology (PAT) initiative published by the Food and Drug administration (FDA) describes PAT systems as important tools to optimize pharmaceutical processes in order to ensure the final product quality. Real-time particle size measurements provide a promising approach for…
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Gellan gum and polyvinylpyrrolidone (PVP) as binding agents in extrusion/spheronization pellet…
The aim of this work was to evaluate gellan gum as binder in pellet formulations, with theophylline as the model drug, in comparison with polyvinylpyrrolidone (PVP). A full 32 factorial design was realized, with binder and dilu- ent factors at three levels each. Pellets were produced by the…
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Hot-melt extruded lipidic pellets for pediatric applications: An investigation of the effects and…
The current study investigates the development of extemporaneous preparation of hot melt extruded diclofenac sodium (Df-Na) pellets processed with glyceryl dibehenate (Compritol® 888 ATO) and dibasic calcium phosphate anhydrous (Fujicalin®) as carriers for pediatric applications. The extruded…
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Biorelevant in vitro assessment of dissolution and compatibility properties of a novel paediatric…
Alkindi® is a novel oral multi-particulate taste-masked formulation of hydrocortisone for use in children with the rare disease adrenal insufficiency. The objective of the present work was to study the biorelevant dissolution and compatibility properties of Alkindi® granules following…
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Development of high drug loaded pellets by Design of Experiment and population balance model…
Medicines of drug coated inert pellets filled into hard capsules or compressed into tablets are already on the market, until now, their number is limited and there are few systematic investigations of possible coating amounts. Pellets of microcrystalline cellulose were coated with a model drug…
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Water-soluble and -insoluble polymers as binders for pellet preparation by extrusion/spheronization
The objective of this study was to investigate the effect of binder (water-soluble vs. -insoluble) and granulation fluid (aqueous vs. organic) on the physical properties of pellet prepared by extrusion/spheronization and on drug release. Size distribution, sphericity, bulk density, crushing force…
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Calibration-free in-line monitoring of pellet coating processes via optical coherence tomography
The paper presents a new in-line measurement technique for determining the coating thickness and uniformity of pharmaceutical pellets during film-coating in a fluid-bed apparatus. Non-destructive and contact-free process monitoring was performed via an optical coherence tomography (OCT) sensor…
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PharSQ Spheres – Calcium Phospate Starter Pellets
Drug layering on starter pellets is a standard technology to achieve multiparticulate dosage forms. The most widely used are still sugar spheres / non-pareils but also neutral pellets made of microcrystalline cellulose such as Cellets are applied. Although not a lot of new starter pellets have come…
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An investigation into the release behavior of solid lipid microparticles in different simulated…
In recent years there has been a growing interest in solid lipid-based systems, particularly in solid lipid microparticles (SLMs); however, only very few studies deeply investigated the dissolution behaviour of orally delivered-SLMs. The present study provides new insights about the release…
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