Extended Release Formulations and Devices

New delivery systems, including devices that provided extended, controlled release of rHuEPO, could allow for smooth, sustained stimulation of erythropoiesis. Such devices necessitate that the molecule remain stable for a prolonged period. Another approach could be to introduce rHuEPO into a slow-release, biodegradable matrix that would erode at a predictable rate and release the protein in a controlled manner (152,153).

To date, no slow-release process has been successful. The requirement for protein stability both during manufacturing and when implanted in the body has been a challenge, particularly when considering biodegradable matrices. Small amounts of contaminating rHuEPO aggregates, misfolded rHuEPO, or breakdown products would probably compromise not only efficacy but also safety (immunogenicity). Another concern is that too rapid breakdown of the matrix might result in an overdose of rHuEPO.

Was this article helpful?

0 0
10 Ways To Fight Off Cancer

10 Ways To Fight Off Cancer

Learning About 10 Ways Fight Off Cancer Can Have Amazing Benefits For Your Life The Best Tips On How To Keep This Killer At Bay Discovering that you or a loved one has cancer can be utterly terrifying. All the same, once you comprehend the causes of cancer and learn how to reverse those causes, you or your loved one may have more than a fighting chance of beating out cancer.

Get My Free Ebook

Post a comment