Addressing non-sterile supply: Is there an easy path to [sublingual] Tirzepatide?

[49metal]

Honestly, I’m sympathetic to the “sterility realists” who are not overly concerned about injecting Tirzepatide supplies that may be less that sterile. But I am still concerned. That said, a number of compounding firms have been producing [sublingual] route Tirzepatide using sublingual RDT (“Rapid Dissolve Tablets”), basically under-tongue lozenges that allow medication be absorbed through the gums. Reports of the effectiveness of these pill formulations seem very positive. My thought is that some bacterial contamination in a[ sublingual] med is far less alarming than in an injectable.

So, how accessible is this RDT approach? Is it s credible option for our purposes? A little goggling produced the following link:

Rapid Dissolve Tablets

SpecializedRx Products, LLC is an FDA registered pharmaceutical excipient manufacturer and repackager providing innovative products for the pharmacy, pharmaceutical, medical device, and related industries.

specializedrx.com

This suggest that there are an array of commercial RDT “base” materials for making pills and these appear easy to get and affordable. There are several base formulas and it would seem assured that one or more will readily host Tirzepatide. Finding out what base the “pros” are using already should be feasible.

With the right base lined up other questions would arise, such as how much more medication is required using this [sublingual] route versus subcutaneous routes? This is probably also obtainable from the disclosures of existing compounders who make the [sublingual] tablet. [NOTE: Henry may be the loudest supplier of [sublingual] Tirzepatide out there and their adds show a bottle of TZP daily pills with”3mg tablets” written on it.]

I don’t know if this approach has been run down already but I figured I’d toss it out there given the ugly sterility tests giving folks the injection willies.

Thoughts? Denunciations?

 

[milos]

EDIT: original thread title used the word "oral" if someone is confused why I was talking about it

Interesting idea, but it's not exactly oral, its sublingual or buccal route of administration, skipping the first pass metabolism, it will also reduce concerns about contamination, but not entirely, as you're still putting it in your mouth, right? Also, the dose required will most likely be higher due to reduced bioavailability and dosing less accurate (you never know the exact amount of drug to get absorbed). I think the best thing is to just use the syringe filter if someone is worried about contamination (e.g. immunocompromised individuals).

 

[Derby]

Making an oral formulation of the current GLP1-RA is basically a joke. The approved oral form of semaglutide is 14mg, vs 0.25 mg parenteral. That's how low the useful absorption is. That same stomach acid that makes sterility a non-issue is also what destroys peptides before they enter the bloodstream. I wouldn't waste my money. In theory, a sublingual form could be more effective, but if it were practical, I suspect Novo or Lilly would have been on it already.

What will be useful is non-peptide GLP1-RAs like orforglipron, which is in Phase III trials at the moment. This has the potential to make a huge dent in the injectable market, but I would bet the price will make our eyes water.

I am definitely in the "whole sterility thing is overblown" camp. I have never heard of anyone, or heard of anyone who has heard of anyone, who has gotten cellulitis from grey market GLP1-RAs.