Particle Sciences wins BHR nasal progesterone contract

Particle Sciences has been tasked with creating a nasal formulation of the steroid hormone progesterone that can be used to treat patients who have suffered traumatic brain injury.

The US-based contract development and manufacturing organisation (CDMO) was contracted by drug developer BHR Pharma late last week.

BHR is already testing progesterone as an intravenous treatment for brain injury in Phase III trial called SyNAPSe in collaboration with the collaboration of contract research organisations (CROs) PRA International and INC Research.

Formulation formula

Particle Sciences specilises in taking poorly soluble molecules - such as those belonging to Biopharmaceutics classification scheme molecules (BCS) II/III/IV - as well as biologics and highly potent compounds and formulating them into more easily delivered products using a variety of technologies.

Just last month, for example, the CDMO completed the manufacture of an intravaginal delivery device for anti-retrovirals that is designed to prevent the transmission of HIV in a project led by the Translational Prevention Research Center at Albert Einstein College of Medicine.

This breadth of capabilities was key to winning the BHR contract according to CEO Dr Mark Mitchnick.

He said:"Our clients often face challenging delivery issues so the dosage forms we work with frequently require a high level of engineering and the simplification of complex formulation challenges to commercially viable products. In this case, the challenge was achieving rapid onset under conditions of true duress, trauma.

"The product had to be versatile and durable. BHR are world leaders in this therapeutic approach and working with their technical team we have been able to design a dosage form that meets their needs. We look forward to helping BHR bring this very important product into the clinic and through to commercialization."