Formulation and Quality – Chemical
Keynote
Robert Williams, III, Ph.D.
Division Head
The University of Texas at Austin
Austin, Texas
Harpreet Sandhu, PhD, MBA
Vice President
Kashiv Pharma, LLC
West Orange
Properties of the drug substance, including solubility, dissolution and gastrointestinal permeability, affect the rate and extent of drug absorption for orally administered drugs. Poorly soluble drugs represent an estimated 90% of drugs being developed. Use of amorphous solid dispersions to enhance a drug’s solubility and oral bioavailability are employed in drug development; and the manufacturing process selected is of critical importance. Thermal processing, including hot melt extrusion and KinetiSol® Dispersing are useful processes for formulating drugs with low water solubility in order to improve their properties, including wetting, dissolution and bioavailability. Excipients, including polymers, are often employed in these processes to formulate the drug as an amorphous solid dispersion. Thermally labile drugs and drugs that have a high melting point (e.g., greater than ~200 degrees C) are often not suitable for processing by hot melt extrusion. KinetiSol® Dispersing, a high energy fusion process not requiring an external heat source, offers a suitable alternative to these difficult to formulate drugs. Processing times differ in terms of minutes versus seconds, for hot melt extrusion and KinetiSol® Dispersing, respectively. This talk will discuss hot melt extrusion and KinetiSol® Dispersing in terms of process selection and limitations, and will include examples of formulations exhibiting enhanced properties.