Am currently working with NIVs and am struggling to understand why, if discovered in the 1970s and first utilised as a drug delivery system (DDS) in 1985 (Chemotheraphy), why has their use as a DDS not been more widely used? Only recently (2012), has their use as a DDS been a primary focus with intention to move into human trials. Has it been a technological barrier? (I.e. manufacturing at a commercial scale) or something else?
Any answers or resource you can direct me to would be amazing.
Thanks in advance.
Michael-Jon Rosslee,
FDA guideline M3(R2) states that:
In vitro metabolic and plasma protein binding data for animals and humans and systemic exposure data in the species used for repeated-dose toxicity studies generally should be evaluated before initiating human clinical trials.
The lack of comprehensive toxicity studies (pre-clinical) for non-ionic surfactants in the past, to warrant a clinical trial could be a reason for the lack of widespread NIV applications.
This might help:
https://www.researchgate.net/publication/239527099_Niosomes_a_review
(Yadav et.al, 2011)
Article Niosomes: a review
These may leave residue in the body and are not easily metabolised.
- Badges
- Science method
- Similar topics
- Biological Science
- Histology
- Staining