A novel insight into fluid bed melt granulation: Temperature mapping for the determination of granule formation with the in-situ and spray-on techniques.

The in-line control of pharmaceutical processes has become a necessary tool for the evaluation and follow-up of pharmaceutical dosage forms. In this study, a novel approach to the evaluation of conditions established in a conical fluid bed granulator during the in-situ and spray-on fluid bed melt granulation (FBMG) techniques was developed. The determination of temperature mappings allowed the characterization of the critical zones during the melt granulation and the prediction of the volume of the wetting zone, hence enabling the identification of the areas of optimal granule growth.

Implementation of an artificial neural network as a PAT tool for the prediction of temperature distribution within a pharmaceutical fluidized bed granulator.

In this study, a novel in-line measurement technique of the air temperature distribution during a granulation process using a conical fluidized bed was designed and built for the purpose of measuring the temperature under the Process Analytical Technology (PAT) and introduced to predict the establishment of temperature profiles. Three sets of thermocouples were used, placed at different positions covering the whole operating range, connected to data acquisition measurement hardware, allowing an in-line acquisition and recording of temperatures every second. The measurements throughout the fluidized bed were performed in a steady state by spraying a solution of PVP onto a lactose monohydrate powder bed in order to make predictions of the temperature distribution and the hydrodynamics of the bed during the granulation process using Artificial Neural Networks (ANNs) and to establish the different temperature profiles for different process conditions through the precise predicted information by the constructed, trained, validated and tested neural network.

Development of gastro intestinal sustained release tablet formulation containing acryl-EZE and pH-dependent swelling HPMC K 15 M.

Background: The aim of this study was to evaluate physical properties and release from matrix tablets containing different ratios of HPMC 15 M and Acryl-EZE. A further aim is to assess their suitability for pH dependent controlled release.

Methods: Matrix tablets containing HPMC 15 M and Acryl-EZE were manufactured using a fluidized bed.