Production process classification system (MCS) based on drug process route
Generally speaking, there are two ways to overcome the bad API properties: first, by adding functional excipients and special design to improve producibility. However, only adding excipients may not be able to overcome the adverse properties of API, especially when the drug loading of the preparation is high. The second method is to form denser and larger particles through granulation, making them easier to process. In the pharmaceutical science academic conference held in May, 2013, different frameworks for establishing MCs were considered, and it was finally decided to develop MCS system according to the process route. This structured approach will help formulation developers cope with the common challenge: how to reasonably select the optimal process route for a specific API. In addition, MCS can help determine the development objectives and design optimization of API, and then use simple processes for processing. We are now carefully collecting more details of different process routes to form the basis of MCS.
Three main general oral solid preparation process routes
(A-C) summarizes three main process routes of general oral solid preparations. These three process routes, as well as the fourth other classification, form the basis of MCS:
(1) Direct pressing process;
(2) Dry granulation;
(3) Wet granulation;
(4) Other processes.
It is very critical for the development of preparation process to be familiar with the requirements of preparation process route for API properties. On the one hand, for a specific API, based on its physical and chemical properties, you can choose a process route with lower risk, and you can also clarify the direction of physical and chemical properties that need to be improved when designing the prescription. On the other hand, according to the physical and chemical properties of API, the choice of crystal / salt form or even compound can be decided, or at least the risk level can be evaluated, so as to make a more optimal decision.
