Abstract
Preparation and formulation of amorphous solid dispersions (ASDs) are becoming more and more popular in the pharmaceutical field because the dissolution of poorly water-soluble drugs can be effectively improved this way, which can lead to increased bioavailability in many cases. During downstream processing of ASDs, technologists need to keep in mind both traditional challenges and the newest trends. In the last decade, the pharmaceutical industry began to display considerable interest in continuous processing, which can be explained with their potential advantages such as smaller footprint, easier scale-up, and more consistent product, better quality and quality assurance. Continuous downstream processing of drug-loaded ASDs opens new ways for automatic operation. Therefore, the formulation of poorly water-soluble drugs may be more effective and safe. However, developments can be challenging due to the poor flowability and feeding properties of ASDs. Consequently, this review pays special attention to these characteristics since the feeding of the components greatly influences the content uniformity in the final dosage form. The main purpose of this paper is to summarize the most important steps of the possible ASD-based continuous downstream processes in order to give a clear overview of current course lines and future perspectives.
Highlights
With the increasing number of poorly water-soluble drug candidates [1], the importance of new formulation technologies and the product development of the so-obtained materials has enhanced [2,3]
A widely used method to increase the flow properties is granulation where it is important to bear in mind that amorphous solid dispersions (ASDs) are very sensitive to mechanical activation, high temperature and moisture, which can all cause the separation of the amorphous phases and possibly the crystallization of the active pharmaceutical ingredients (APIs) [18]
Many drug products consisting of extruded samples have been approved so far and continuous downstream processing systems, where hot-melt extrusion (HME) is coupled with injection molding or 3D printing, have appeared in the literature recently [28,29]
Summary
With the increasing number of poorly water-soluble drug candidates [1], the importance of new formulation technologies and the product development of the so-obtained materials has enhanced [2,3]. The feeding performance deteriorates, which could lead to drug content variation in the blends and in the tablets or capsules [17] These errors result in poor quality products in a batch process but even more in continuous technologies. A widely used method to increase the flow properties is granulation where it is important to bear in mind that ASDs are very sensitive to mechanical activation, high temperature and moisture, which can all cause the separation of the amorphous phases and possibly the crystallization of the API [18] To prevent these, another solution could be the application of diverse excipients that ensure good flowability. Feeder performances and the connected analytical and evaluation methods are discussed
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
