Characterization of particle sizes in bulk pharmaceutical solids using digital image information.

The purpose of this study was to demonstrate a novel method of extracting relevant information from undispersed bulk powder surfaces to be used in particle size analysis. A new surface imaging approach for undispersed powders combined with multivariate modeling was used. Digital surface images of various granule batches were captured using an inventive optical setup in controlled illumination conditions.

New perspectives for visual characterization of pharmaceutical solids.

The utilization of descriptive image information in pharmaceutical powder technology is rather limited. Consequently, the development of this discipline is a challenge within physical characterization of pharmaceutical solids. The aim of this study was to develop and evaluate an inventive visual characterization approach for monitoring the granule growth in a fluidized-bed granulation process and to use the generated image information in the prediction of tabletting behavior of granules.

A novel technique for imaging film coating defects in the film-core interface and surface of coated tablets.

Confocal laser scanning microscopy (CLSM) was introduced and examined as a novel technique for imaging film-core interface and surface defects of film-coated tablets. Tablets of acetylsalicylic acid, microcrystalline cellulose (MCC) and lactose monohydrate were film-coated with aqueous hydroxypropyl methylcellulose using an instrumented side-vented pan coater. The film coatings were applied using 100- and 500-kPa spraying air pressures.

Measurement of pharmaceutical particles using a time-of-flight particle sizer.

The Aerosizer is an instrument for time-of-flight measurement, which is widely used in particle size determinations. The results of various studies indicate that there are still some problems related to the optimization of the analysis conditions. In this study, the behaviour of a set of different kinds of pharmaceutical particles during Aerosizer measurements was studied.

Does a powder surface contain all necessary information for particle size distribution analysis?

The aim of this study was to utilise a new approach where digital image information is used in the characterisation of particle size distributions of a large set of pharmaceutical powders. A novel optical set-up was employed to create images and calculate a stereometric parameter from the digital images of powder surfaces. Analysis was made of 40 granule batches with varying particle sizes and compositions prepared with fluidised bed granulation.

Tablet film-coating with amylose-rich maize starch.

The purpose of the present study was to investigate an aqueous-based amylose-rich maize starch (Hylon VII) film-coating process of tablets performed by a side-vented pan coating system. Three formulation or process parameters of potential importance, including the plasticizer concentration (X(1)), the temperature of coating pan (X(2)) and the spray rate of the coating solution (X(3)), were evaluated using a central composite face-centred experimental design. Only a few process-related limitations associated with the aqueous film coating of Hylon VII were observed, and, in general, the coated tablets were of fairly good quality.