For developers in need of formulations specifically for toxicology and/or pharmacokinetic studies, Particle Sciences has the solution. Frequently, our Clients find their commercial dosage form is not appropriate for non-clinical testing. Issues range from inability to achieve high enough exposure to there being no appropriate non-human version of the drug product.
Particle Sciences has developed a program to specifically address this need. We have an array of formulation techniques that uniquely qualifies us for this work: solid solutions, nanoparticulate dispersions and lipid based formulations. This coupled with complete analytic and bioanalytic services means that Particle Sciences can offer our Clients a single source solution to difficult toxicology and pharmacokinetic testing challenges.
For those Clients needing assistance with arranging nonclinical testing, Particle Sciences has partnered with Calvert Laboratories, a leading non-clinical facility. Through the Calvert Preferred Partner Network, we offer a completely integrated program where Particle Sciences formulates the product and Calvert Laboratories performs the testing. Analytic and bioanalytic work are performed at Particle Sciences. Both GLP and non-GLP programs are available.
Case Study 1: Client has a vaginal ring in Phase III and needs to do perform long term carcinogenicity testing. The “ring” was an inappropriate vehicle for the traditional species. Particle Sciences created a gel containing the relevant amounts of the client’s API. In addition, Particle Sciences manufactured the gel under GLPs and performed all the associated analytic work.
Case Study 2: Client developed a solid oral drug product of an anti-retrovial. The drug was insoluble and the client was unable to arrive at a formulation suitable for IV administration which was needed to complete the non-clinical toxicology studies. Particle Sciences developed a nanoparticulate dispersion that achieved the needed plasma levels. In this case, Particle Sciences also developed the analytic and bioanalytic methods and performed the analysis.