Influence of raw material properties upon critical quality attributes of continuously produced granules and tablets.

Continuous manufacturing gains more and more interest within the pharmaceutical industry. The International Conference of Harmonisation (ICH) states in its Q8 'Pharmaceutical Development' guideline that the manufacturer of pharmaceuticals should have an enhanced knowledge of the product performance over a range of raw material attributes, manufacturing process options and process parameters. This fits further into the Process Analytical Technology (PAT) and Quality by Design (QbD) framework. The present study evaluates the effect of variation in critical raw material properties on the critical quality attributes of granules and tablets, produced by a continuous from-powder-to-tablet wet granulation line. The granulation process parameters were kept constant to examine the differences in the end product quality caused by the variability of the raw materials properties only. Theophylline-Lactose-PVP (30-67.5-2.5%) was used as model formulation. Seven different grades of theophylline were granulated. Afterward, the obtained granules were tableted. Both the characteristics of granules and tablets were determined. The results show that differences in raw material properties both affect their processability and several critical quality attributes of the resulting granules and tablets.

Laser-induced damage in composites of scandium, hafnium, aluminum oxides with silicon oxide in the infrared.

The laser-induced damage of mixtures of Sc2O3, HfO2, Al2O3 with SiO2 has been characterized in the infrared for both nanosecond and subpicosecond pulses. Laser-induced damage thresholds (LIDTs) are reported and discussed versus band gap for different compositions. The distributions versus fluence of nanosecond damage precursor densities are extracted fitting damage probability curves. Two models are used: first, a statistical approach, i.e., direct calculation of damage precursor density from damage probability, and second a thermal model based on absorption of initiator. The results show a good agreement. The nature, shape, and size of these precursors are discussed. The critical temperature in the thermal model is dependent on the band gap energy.

Tailored beads made of dissolved cellulose--investigation of their drug release properties.

In the frame of this work, we have investigated drug entrapping and release abilities of new type of porous cellulose beads (CBs) as a spherical matrix system for drug delivery. For that purpose, CBs prepared with three different methods were used as drug carriers and three compounds, anhydrous theophylline (Thp), riboflavin 5'-phosphate sodium (RSP) and lidocaine hydrochloride monohydrate (LiHCl) were used as model drug substances. The loading procedure was carried out by immersing swollen empty beads into the solutions of different concentrations of model drugs. The morphology of empty and loaded beads was examined using a field emission scanning electron microscopy (FE-SEM). Near-infrared (NIR) imaging was performed to identify the drug distributions on and within the loaded CBs. The drug amount incorporated into CBs was examined spectrophotometrically and in vitro drug release studies were performed to determine the drug release rates. The results of FE-SEM and chemical NIR imaging analyses revealed that incorporated drug were distributed on the surface and but also within the internal structure of the CBs. Physical properties of CBs and solubility of model drugs had effect on loading efficacy. Also, the drug release rates were controlled by solubility of model drugs (diffusion controlled release). In conclusion, CBs from dissolved cellulose show promise in achieving controlled drug delivery.