Applying quality risk management to develop an isolator filling line

Compounds that are poorly soluble in water are still prevalent in the pharmaceutical industry drug development pipeline.

Poorly soluble drugs for oral administration present unique formulation challenges, particularly during early development. Formulation in a lipid-based carrier can be a feasible approach, but usually requires extensive testing to find suitable excipient combination.

No longer just a catch phrase, digital transformation in pharma manufacturing is more critical today than ever before and the industry is getting on board.

Enabling formulations becomes more and more necessary to obtain adequate exposure of APIs during (pre)-clinical research. Currently, most registered formulations to improve bioavailability are based on lipidic systems, which make use of intrinsic digestion processes within the GI tract, facilitating the absorption of APIs. Aside from a general absorption mechanism, lipidic systems can also promote lymphatic transport of poorly soluble drugs, such as hormones. In addition, many different indications, such as HIV therapy, oncology, immunosuppressant and even arising therapies related to medicinal cannabis (e.g. CBD) can benefit from lipid formulations. These formulations create multiple possibilities for oral administration because they can be manufactured as solutions, suspensions, emulsions, and self-(micro)emulsifying systems.