Biomedical subjects

Jørn M Sonnergaard

Publications and source records attributed to Jørn M Sonnergaard.

4 recordsLinked to original sources

PubMed2006

Quantification of the compactibility of pharmaceutical powders.

The purpose of this study is to investigate and to quantify the compactibility of pharmaceutical powders by a simple linear relationship between the diametral compressive strength of tablets and the applied compaction pressure. The mechanical strength of the tablets is characterized as the crushing force normalized with the dimension of the tablet and termed the specific crushing strength, SCS. The proposed model: SCS=Cp*P+b estimates the slope of the regression line Cp as a dimensionless compactibility parameter and is reported with the corresponding standard deviation SCp. The linear region of the compactibility profile is selected using the 95% predictability limits bordering the regression line. Eleven different materials were tested and acceptable fits to the linear model were observed in all cases. The ability of the model to discriminate between the investigated materials is excellent, in cases where the difference may be difficult to show a simple t-test is used as an inference tool. No difference was found between lactose tablets of different masses (500 and 1000 mg). A relationship between the compactibility parameter and the compressibility characterized by the Walker coefficient is demonstrated.

Chemistry, Pharmaceutical↗

PubMed2003

Validation of an image analysis method for estimating coating thickness on pellets.

A digital image analysis method for the estimation of mean pellet size and coating thickness employing optical microscopy was evaluated. The coating thickness was expressed as the difference in mean projected area radius of the uncoated and the coated pellets. The repeatability, the intermediate precision and the robustness of the image analysis method were investigated. The repeatability and the intermediate precision of the image analysis method was excellent with a low degree of scatter between the measurements. The robustness investigation on the image analysis method illustrated the importance of controlling and monitoring the illumination technique utilised. Calibration of the image analysis equipment was of the highest importance. Using pellets with a high degree of sphericity and narrow size distribution, it was sufficient to use 1000 pellets to estimate the mean pellet size and the coating thickness with an accuracy of +/-1.2 microm. An equation is presented for an approximation of the number of pellets necessary to achieve a given accuracy in the estimation of mean pellet size and coating thickness.

Drug Implants↗

PubMed2003

A new process control strategy for aqueous film coating of pellets in fluidised bed.

The parameters with effect on maximum spray rate and maximum relative outlet air humidity when coating pellets in a fluidised bed were investigated. The tested variables include type of water based modified release film coating (Eudragit NE 30D, Eudragit RS 30D, Aquacoat ECD) coating principle (top spray, bottom spray), inlet air humidity and type of pellets (sugar spheres, microcrystalline cellulose pellets). The maximum spray rate was not influenced by the coating principles. The highest spray rate was obtained for the film polymer with the lowest tackiness which is assumed to be the controlling factor. The type of pellets affected the maximum spray rate. A thermodynamic model for the coating process is employed throughout the process and not just during steady state. The thermodynamic model is incorporated into a new process control strategy. The process control strategy is based on in-process calculation of degree of utilisation of the potential evaporation energy (DUE) of the outlet air and the relative outlet air humidity (RH). The spray rate is maximised using set points of DUE and RH as control parameters. The product temperature is controlled simultaneously by regulating the inlet air temperature.

Drug Implants↗

PubMed2002

Distribution of crushing strength of tablets.

The distribution of a given set of data is important since most parametric statistical tests are based on the assumption that the studied data are normal distributed. In analysis of fracture mechanics the Weibull distribution is widely used and the derived Weibull modulus is interpreted as a material constant. However, the estimation of this parameter is laborious and subject to estimation problems. It is shown that the Weibull modulus is inherently connected to the coefficient of variation and that the information obtained from the modulus is unclear. The distribution of crushing strength data from nine model tablet formulations and four commercial tablets are shown to follow the normal distribution. The importance of proper cleaning of the crushing strength apparatus is demonstrated.

Compressive Strength↗