Effect of relative humidity on onset of capillary forces for rough surfaces

Process Simulation and Data Modeling in Solid Oral Drug Development and Manufacture

“…Thermodynamic models for the prediction of solubility are widely used in the pharmaceutical industry for designing unit operations such as crystallization [72][73][74][75][76][77]. This is because these models are accurate enough to save development time by guiding researchers in the right direction towards desired solubility profiles.…”

“…Particle breakage in agitated dryers was investigated by Hare et al [75] using DEM to evaluate stresses and strains due to shear deformation. Strain rates were validated experimentally using PEPT.…”

“…Similar methods could be applied to feasibility analysis of integrated networks of processing equipment for the manufacture of pharmaceutical products. Finally Linninger and Chakraborty [75] have applied deterministic flexibility methods, among other approaches, to develop robust waste management procedures for pharmaceutical plants given production and scheduling uncertainty.…”

“…However, due to rising research and development expenditures, rising manufacturing costs, expiration of drug patents, and competition from generic manufacturers, the industry has recognized the need to alter its manufacturing practices to improve operational efficiency. The proper regulation of such particulate processes in the pharmaceutical industry is of immense importance due to the imposition of a tight quality criteria [75]. The Quality by Design (QbD) initiative launched by the US FDA suggests that quality should be built into a product based on a thorough understanding of the product and process by which it is developed and manufactured, along with an in-depth knowledge of the risks involved in manufacturing the product and procedures to mitigate those risks.…”

“…The Quality by Design (QbD) initiative launched by the US FDA suggests that quality should be built into a product based on a thorough understanding of the product and process by which it is developed and manufactured, along with an in-depth knowledge of the risks involved in manufacturing the product and procedures to mitigate those risks. Thus, it is beneficial for a pharmaceutical company to implement a process systems engineering-based approach with heavy focus on modeling in order to attain a sustainable position in the market [31,75,89]. A model-based systems approach can play a crucial role in the design, operation, evaluation, and analysis of processes because of its potential to provide better process understanding, leading to a reduction in the time and cost for the operation of the process [31,39].…”