Particle Engineering of neat Active Pharmaceutical Ingredients
Particle engineering is of crucial relevance for the production of oral forms of poorly soluble drugs, as proven by the micronized and more recently nanosized formulations which have been marketed. A fine control of size and polymorphism (crystal engineering) is also required for the development of inhalable drugs, combination therapies and challenging drugs with a narrow therapeutic index.
Nevertheless, tailored and differentiated drug particles with low solvent residues are often difficult to produce in a reliable way by currently available techniques such as crystallization or milling, thus hindering the development of new chemical entities and enhanced formulations of off-patent drugs.
Stability of Biopharmaceuticals
The development of biotechnology medicines has highlighted issues such as stability during manufacturing operations and long-term storage. These quality and safety issues are basically related to the poor stability of proteins that can be altered by pH, shear stress, surface interactions and temperature leading to potentially immunogenic protein modifications.
There is thus a strong need to develop bulk and final product manufacturing techniques that reduce or prevent denaturation, aggregation and other structural changes of biologics so as to quickly get challenging biopharmaceuticals to the market.