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steelyeye

02/05/20 9:38 PM

#281276 RE: djs7 #281275

Good article, thanks... and a lot more recent than that 30 year old article. It appears that the kinds of coatings that lead to rates of disintegration along the digestive track, (further down than the small intestine) are the most important factors in focusing drug delivery.

Let's see what BDD can deliver, and where.

Safety is already established (from trials of B with other indications). But if BDD can hit the target and Oralogik can show it, how might we price Brilacidin for UC and Crohn's?




check out these results on colonic delivery (2011 Article).

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3549889/

loanranger

02/06/20 9:44 AM

#281284 RE: djs7 #281275

Thanks for digging that out. It was very informative but the issue of the effect of or need for agitation in the colon wasn't part of the question. The linked abstract didn't "explain how BDD and IPIX will be able to direct Brilacidin to the specific area of inflammation in various colitis patients when the OralogiK release system is time based (versus ph based), given the significant variations in transit time in the colon from patient to patient".

But maybe I'm wrong about my underlying assumption.
I know this to be true: UC affects a specific area within the colon, variable from patient to patient, not the entire colon.
I believe it has previously been shown that BDD's system can avoid release of the drug prior to arriving at the colon thus depositing the drug therein and I don't believe that the current trial was needed to establish that.
The current trial is using healthy subjects and I expect it to show that the drug arrived in the colon as planned. Is it your understanding that the drug is intended to treat the ENTIRE colon versus just the diseased area?

The 30 year old study indicated that transit through the colon "varies from a few hours to 2 days". The in vitro graph of one of your study's formulations covers cumulative release over 10 hours. BDD's Colonic Delivery page says "Tailored release of drug between 1 and 12 hours after dosing" (https://www.bddpharma.com/copy-of-controlled-release). The UP trial was relatively straightforward....the drug could reliably be applied to the specific area of inflammation and be expected to stay in contact with it for some period of time. It will be interesting to see if the gamma scintigraphy results from the current trial quantifies those things in the healthy subjects.

"Particles embedded in the drug can be free flowing, check out these results on colonic delivery (2011 Article)."
Again the article is interesting. It talks about using a drug in the form of microspheres: "The microspheres are characteristically free-flowing powders composed of synthetic polymers". I didn't see anything in the BDD Oralogik pages talking about the use of microspheres, free-flowing or otherwise, so I'm not sure if that's relevant to the Brilacidin pill.


It was interesting to see that your study used Evonik's enteric coating. Remember them?


FYI, just in case microshperes ARE relevant:
https://www.mdpi.com/2218-0532/87/3/20/htm