A CDMO Perspective on the Formulation of Complex Dosage Forms
25 April, 2019

It is well recognized that many existing active pharmaceutical ingredients (API’s) and new chemical entities (NCE’s) are poorly water soluble and subsequently have low oral bioavailability if formulated in unmodified form. These compounds are also challenging to formulate for other routes of administration, especially parenteral. The prevalence of low solubility compounds has led to intensive research and has generated many technologies to address formulation; although one size doesn’t fit all, some may fit more than others. These technologies include chemical means, such as salt or pro-drug formation (not always an option), physiochemical modification of the crystal structure including amorphous forms, co-crystals, formulation with lipidic solubilizers, encapsulation by cyclodextrins, and particle size reduction techniques such as conversion into nanoparticulate suspensions (NSs)/nanocapsules or into solid solutions/dispersions.  This presentation will describe some of the drug delivery technologies Particle Sciences uses to address their Clients’ formulation requirements.