The paper reviews technology developments and market trends surrounding Additive Manufacturing (AM, also known as 3D Printing), which has received much interest and attention in the past few years from variety of audiences both industrial users and non-industrial users. The paper will also touch on initiatives taken towards AM around the world and explain measures that are taken to accelerate adoption of AM into conventional manufacturing and to seek new application of AM.
Demand on generic drug is being increased recently, and high quality level and stable supply are required to generic pharmaceutical company as well as innovative pharmaceutical company. To achieve that, implementation of ICH Q trio is necessary. Implementation of ICH Q trio should be considered in R&D development phase, but for legacy product, it has to be done in production phase. PAT and QbD approach support these challenge on legacy product. At this time, several examples are introduced about how to achieve these challenges in Takayama plant of Teva.
In this study, α-Al2O3 particles were synthesized from alumina precursor solution stabilized with formic acid (abbreviated as AlFo3). The drying process of AlFo3 affected on the phase transformation and morphology of the synthesized α-Al2O3 particles. The powder obtained through drying of AlFo3 at 150℃ in drying oven transformed to α-Al2O3 single phase at the temperature of 950℃, which is about 200℃ lower than that reported in the typical precursor of aluminum hydroxide.
Si doping magnetite particles were synthesized by hydrothermal using of silane coupling agents. According to increase the amount of the silane coupling agent, the crystallite diameter of the magnetite particles was reduced. The saturation magnetizations tend to decrease gradually with an increase in the content of Si, and the coercivity was rapidly decreased. According to increasing the amount of the silane coupling agents, the dispersibility of the particles by working silicon and carbon functionalities was improved. These magnetite particles were reduced by H2 gas and nitrided by NH3 gas. In the case of the using the pure magnetite, it was not only synthesized with α-Fe. In the case of the magnetite doped with the silicon content of 1.6 mol% and 2.7mol%, α"-Fe16N2 could be synthesized. Furthermore the case of silicon addition 4.2 mol%, α-Fe particles kept and the coercivity was decreased.
In order to progress the millings toward the advance technologies, authors has investigated the visualization methods in milling procedure and optimized its operations. From the wet ball milling experiments for some ceramics materials, we have obtained results as follows, 1) it is able to detect their specific surface area changes by the relaxation time measurements according to the in situ analysis with pulse proton NMR, 2) measured data shows the milling efficiency in several steps, and 3) we can make use of these dynamic changes as the operation control fundamentals. Therefore, we recognized the possibilities of making advances on the milling process and developing its control systems.
In this study, a novel continuous manufacturing system composed of mixing, kneading, granulation, and drying has been developed and its performance was evaluated experimentally.
First of all, agitation torque during kneading process was continuously measured using different kinds of powder samples and binder liquid addition ratios, and state of liquid/powder mixture was analyzed. Residence time and hold-up of wet kneaded mass were also measured during the kneading process. Based on the results obtained, the optimum operating regions of screw agitation speed and powder feed rate were determined. Orally rapidly disintegrating tablets were then prepared by the granules made by the continuous system and properties of tablets were evaluated. It was found that the optimum binder addition rate could produce orally rapidly disintegrating tablets with favorable properties.