Bubendorf, Switzerland
Bubendorf, Switzerland

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Pomerantsev A.L.,RAS Semenov Institute of Chemical Physics | Rodionova O.Y.,RAS Semenov Institute of Chemical Physics | Melichar M.,GEA Pharma Systems AG | Wigmore A.J.,GEA Pharma Systems AG | Bogomolov A.,J and M Analytik AG
Analyst | Year: 2011

A new method for the prediction of the drug release profiles during a running pellet coating process from in-line near infrared (NIR) measurements has been developed. The NIR spectra were acquired during a manufacturing process through an immersion probe. These spectra reflect the coating thickness that is inherently connected with the drug release. Pellets sampled at nine process time points from thirteen designed laboratory-scale coating batches were subjected to the dissolution testing. In the case of the pH-sensitive Acryl-EZE coating the drug release kinetics for the acidic medium has a sigmoid form with a pronounced induction period that tends to grow along with the coating thickness. In this work the autocatalytic model adopted from the chemical kinetics has been successfully applied to describe the drug release. A generalized interpretation of the kinetic constants in terms of the process and product parameters has been suggested. A combination of the kinetic model with the multivariate Partial Least Squares (PLS) regression enabled prediction of the release profiles from the process NIR data. The method can be used to monitor the final pellet quality in the course of a coating process. © 2011 The Royal Society of Chemistry.


Bogomolov A.,J and M Analytik AG | Engler M.,J and M Analytik AG | Melichar M.,GEA Pharma Systems AG | Wigmore A.,GEA Pharma Systems AG
Journal of Chemometrics | Year: 2010

Near infrared (NIR) and Raman spectroscopic analyzers applied through an immersion Lighthouse Probe (LHP) were used for simultaneous in-line monitoring of a fluid bed pellet coating process. Multivariate curve resolution analysis of data, collected from four pilot-scale batches, has shown that the two techniques deliver complementary information about the process and their combination may be synergistic. This data analysis enabled a much better understanding of some of the process observations and also gave some interesting insights into the best way to use the techniques themselves. PLS regression analysis of the product moisture and the quantity of coating material sprayed was performed using NIR and Raman data blocks both separately and in combination. The performance of method combination compared to individual techniques is analyzed and discussed. Copyright © 2010 John Wiley & Sons, Ltd.


Patent
Gea Pharma Systems Ag | Date: 2010-08-30

The fluid bed apparatus has a chamber (1) including a plenum (11) and a perforated base plate (3) is located above the plenum (11). An inlet (2) and an outlet (7) are provided for process gas. A discharge opening (8) has a lower edge (8a) and an upper edge (8b) and defining a height and an opening area, the base plate (3) being positioned above the lower edge (8a) of the discharge opening (8) such that the opening area of the discharge opening (8) is divided into an opening area (Aa) below the base plate (3) and an opening area (Ap) above the base plate (3).

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