SSCI can help solve your most difficult solid-state problems. For example, when the solid form of a pharmaceutical company's clinical trial material inadvertently varies from batch to batch, we can determine the properties of the different forms used, perform dissolution testing, recommend whether a bridging study needs to be carried out, and propose specific bridging study content. When a new polymorph appears during clinicals or after commercialization, we can analyze the solid form issues and assist in rapid reformulation or recommend effective process changes.
SSCI scientists are experts at contaminant analysis for both API and drug product and we have experience with a wide variety of dosage forms. We investigate causes of failure to meet specifications, particularly dissolution specifications.
We can help when a new solid form appears or when drug product fails to meet specifications.
SSCI is also experienced in the investigation of drug product stability and integrity failures such as friability and chipping of tablet coating or formation of haze in parenteral products. We determine the effect of excipients on product stability and we have strategies for solubilization of poorly soluble drugs.
In the specialty and industrial chemicals industries, we help clients improve the solubility or flow properties of their solid products.