DiPP: Tableting Unit Operation, Process Variables, Optimizing Tablet Property and Energy Consumption

Abstract

Pharmaceutical manufacturing processes have recently shifted from batch to continuous operations in order to reduce costs and increase productivity. The continuous manufacturing comprises five-unit operations which are twin screw granulation, fluidized bed dryer, milling, blender, and tableting press. This work focuses on the tableting unit operation, which compresses the pharmaceutical powder into uniform-sized tablets. The tableting unit consists of several process variables such as turret speed and compression force. There have been previous studies in tablet production that investigated the influence of various process variables on the physical properties of the tablet with limited numbers of tablets. This research purpose was to investigate the impact of these variables on final tablet attributes. Also, the optimum conditions for producing tablets with optimum tensile strength (1.7 MPa) with the lowest amount of energy consumed were investigated. Furthermore, the research investigated the effect of moisture content on the tablet’s tensile strength using the Loss on Drying method. To improve the accuracy and stability of the results, 2200 tablets were tested for this research. Different compression force values ranging from 5 KN to 24 KN were examined in this work. Additionally, various turret speed values ranging from 10 rpm to 100 rpm were analyzed. The materials used are a mixture of 72% Lactose monohydrate 200M, 24% Microcrystalline Cellulose, and 4% Hydroxypropyl Cellulose. A semi-automated hardness tester was used to measure the tablet's physical properties. The findings of the research indicated that when the compression force increases the tensile strength increases correspondingly. This work proves this phenomenon with a total of 1000 tablets examined under five different compression pressure values to enhance the reliability and stability of the findings. It is notable that at the lowest compression force, 5 KN the tensile strength was the lowest while at the highest compression force of 24 KN the tablet's tensile strength was the highest. It is demonstrated that the relation between the compression force and tensile strength is a linear relationship. Moreover, this work proved the inverse relation between the turret speed and tensile strength with 1000 tablets exposed to five different turret speeds. Regarding energy consumption, it is recommended that 15 KN and 40 rpm might be the optimum process values that will produce a tablet that meets the optimum tensile strength value with lower energy consumption and shorter production time. Moreover, this study indicated that maintaining the tablet's moisture content within the permissible range could increase the tensile strength of the tablet. Future studies could examine the dissolution profile under various process variables to better understand the effects of tableting process variables on drug release behavior.