Osmolality Testing of Viscous Formulations Using Freezing Point Depression

The trend towards higher concentration formulations poses various issues for the pharmaceutical industry, with an increased concentration often leading to a higher viscosity. Simultaneously, subcutaneous injections are proving more popular with both patients and healthcare providers due to their efficacy, safety, and reduced drug-delivery costs¹. However, these trends together mean that the concentration logically increases due to the lower volumes administered.

This, in turn, impacts their osmolality measurements due to the likelihood of increased viscosity when producing higher concentration solutions. Examples of excipients incorporated into these formulations include hyaluronic acid (HA), sodium hyaluronate, and glycerols. Osmolality is a key process parameter in formulation development and product stability. However, prior to the launch of the OsmoTECH^® XT Micro-osmometer, the increase in popularity of these higher concentration formulations and harder to handle components posed a challenge for freezing point osmometers.