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Flawil, Switzerland

Vranic B.Z.,University of Basel | Vranic B.Z.,BUCHI Labortechnik AG | Vandamme T.F.,University of Strasbourg
Pharmaceutical Development and Technology

A preliminary study of the feasibility of using near-infrared spectroscopy (NIRS) for the offline simultaneous determination of metoprolol tartrate (MTP) and hydrochlorothiazide (HTZ) in powders and tablets has been carried out. An industrial tableting process was simulated using an instrumented tablet press replicator - Presster™. Conventional reference analytics were replaced with gravimetric analysis. The NIRS models for powder and tablet analysis were developed using 55 samples, and tested on 80 independent samples. Powder mixture components were weighed in glass vials to collect reference values, mixed and manually transferred to a tablet press replicator and compacted to form tablets. NIRS calibration models were developed using spectral and gravimetric reference data. The two model drugs were simultaneously quantified exhibiting root mean-squared error of prediction (RMSEP) of 1.69 and 1.31mg for HTZ powder and tablet samples, respectively, and RMSEP of 3.15 and 3.00 mg for MTP powder and tablet samples, respectively. NIRS analysis of MTP and HTZ in powder and tablet form has not been reported elsewhere. © 2015 Informa Healthcare USA, Inc. Source

Arpagaus C.,BUCHI Labortechnik AG
Drying Technology

This paper reviews the advances in nanoparticle spray drying performed in a laboratory environment and with the Nano Spray Dryer B-90, which was introduced by BUCHI Labortechnik AG in 2009. Special regard will be paid to relevant published works. The technological novelty of the patented Nano Spray Dryer B-90 lies in the gentle laminar drying flow, the vibrating mesh spray technology, and the highly efficient electrostatic particle collector.Recent studies prove the successful use of this spray dryer for a variety of drug delivery applications, such as poorly soluble drugs (e.g., griseofulvin, furosemide), enzymes (e.g., galactosidase), proteins (bovine serum albumin, whey protein), amino acids (e.g., leucine), polysaccharides (e.g., trehalose, lactose), salts, encapsulation of nano-emulsions in polymeric wall materials, as well as materials science applications (e.g., battery-grade lithium carbonate).The Nano Spray Dryer B-90 makes it possible to produce spray-dried particles in the submicron scale and to create tiny particles of down to only 350-500 nm. In contrast to traditional laboratory-scale spray dryers, it can achieve uniquely high yields of up to 94% for powder amounts down to the milligram scale (e.g., 3.0-500 mg). © 2012 Copyright Taylor and Francis Group, LLC. Source

Moret S.,University of Udine | Scolaro M.,University of Udine | Barp L.,University of Udine | Purcaro G.,University of Udine | And 2 more authors.
Food Chemistry

Pressurised liquid extraction (PLE) represents a powerful technique which can be conveniently used for rapid extraction of mineral oil saturated (MOSH) and aromatic hydrocarbons (MOAH) from dry foods with a low fat content, such as semolina pasta, rice, and other cereals. Two different PLE methods, one for rapid determination of superficial contamination mainly from the packaging, the other for efficient extraction of total contamination from different sources, have been developed and optimised. The two methods presented good performance characteristics in terms of repeatability (relative standard deviation lower than 5%) and recoveries (higher than 95%). To show their potentiality, the two methods have been applied in combination on semolina pasta and rice packaged in direct contact with recycled cardboard. In the case of semolina pasta it was possible to discriminate between superficial contamination coming from the packaging, and pre-existing contamination (firmly enclosed into the matrix). © 2014 Elsevier Ltd. All rights reserved. Source

Vranic B.Z.,University of Basel | Vranic B.Z.,BUCHI Labortechnik AG | Vandamme T.F.,University of Strasbourg
Pharmaceutical Development and Technology

Near-infrared spectroscopy (NIRS) is used in the pharmaceutical industry for monitoring drug content during the tablet manufacturing process. It is of critical importance to understand the effect of process factors on NIRS performance. Design of Experiments (DoE) methodology was applied in this work for the systematic study of the effects of compression pressure, precompression pressure and tableting speed on an average Euclidean distance (AED), which reflects spectral features of the tablets, and root mean-squared error of prediction (RMSEP) as key performance indicator of NIRS calibration models. Caffeine tablets were manufactured in 17 experimental runs in accordance with D-optimal design. Developed diffuse transmittance (DT) and diffuse reflectance (DR) calibration models were tested on five independent test sets to confirm the conclusions of the DoE. Compression pressure and tableting speed have shown significant effect on the studied responses in DT mode, whereas all three studied factors have shown a significant effect in DR mode. Significant factors were considered in the development of the global calibration models. The authors suggest further study of RMSEP and AED responses to draw reliable conclusions on the effects of tableting process factors. The global calibration model in DT mode has shown superior performance compared to DR mode. © 2015 Informa Healthcare USA, Inc. Source

Elzoghby A.O.,Alexandria University | Vranic B.Z.,BUCHI Labortechnik AG | Samy W.M.,Alexandria University | Elgindy N.A.,Alexandria University
International Journal of Pharmaceutics

In this study, spray-dried alfuzosin hydrochloride (ALF)-loaded casein (CAS) nanoparticles were successfully used for the preparation of a swellable floating matrix via direct compression. The developed NIR calibration model was able to assess ALF and CAS levels in five different batches of drug-loaded nanoparticles. The calibration and prediction plots exhibited good linearity with correlation coefficients of more than 0.9. The standard error of calibration and cross-validation was less than 5% of the measured values, confirming the accuracy of the model. A linear relationship was obtained correlating the actual drug entrapped and the predicted values obtained from the NIR partial least squares regression model. The un-crosslinked tablet demonstrated a substantial weight gain (317% after 2 h) and completely disintegrated after 3-4 h whereas both 10 and 40% w/w genipin-crosslinked tablets showed lower weight gain (114 and 42% after 2 h, respectively). A rapid floating of the tablets within 5-15 min (compared to 45 min for the marketed tablet) was observed, with maintained floating for 24 h. Marketed and prepared tablets succeeded to prolong ALF release for 24 h. The development of drug-loaded CAS nanoparticles using spray-drying represents a new alternative for the preparation of swellable floating tablets for prolonged drug release. © 2015 Elsevier B.V. All rights reserved. Source

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