"Most rings are solid and made in a mold or extruded where the drug is trapped within the polymer that the ring is primarily made of. In this case, the ring is a hollow tube that is filled with a powder. The powder consists of the drug and excipients. The tube is filled with the powder and then the ends are “welded” to form the ring. So, methods to fill and weld under cGMP’s were needed," said Maureen Grieco of Particle Sciences.
This new ring is aimed at HIV prevention and joins several other microbicide delivery approaches under development at Particle Sciences. Studies conducted at the Center for Disease Control showed the ring was effective in providing complete protection in macaque primates against HIV and the related virus SHIV.
The ring should be made available to the public fairly soon.
"The ring is just entering into its FiH (first in humans) trial although the drug itself is well known. At this early stage a commercialization date is not known but typically it takes a product like this 5+ years to get from FiH to commercial availability," Grieco said.
According to Mark Mitchnick MD, Particle Sciences' CEO, "Particle Sciences focuses on formulation design and manufacturing. Given the issues our clients face, the dosage forms we work with often require a high level of engineering and reducing complex formulations to commercially viable products is something we frequently do. In this case, the product is a drug eluting device funded under an NIH grant led by Betsy Herold, M.D., Professor and Director, Translational Prevention Research Center at Albert Einstein College of Medicine.
The product itself was designed by Patrick Kiser, PhD, Associate Professor of Biomedical Engineering at Northwestern University." Mitchnick added, "We have worked very hard to make Particle Sciences the go-to resource for complex formulation and manufacturing. This year alone, in addition to this product, we have manufactured sterile nano-dispersions, IV emulsions, IM sustained release suspensions and a host of other products, the majority of which were developed at Particle Sciences. We have a long history with prevention technologies and were delighted to be able to work on this one.