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Repackaging high dose vials, safety

Nathanologist

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Hello friends…

Any thoughts on repackaging higher dose vials into lower dose vials? Like if you got a 60mg lyophilized vial and opened it up, weight out 6 10mg doses and put them into 6 new vials and sealed them up.

Sterile process is needed of course. Just curious if anybody has done it. What the pitfalls to avoid would be. What tools would be needed.

Minimum would be sterile environment/field, sterile tools for transferring and measuring powder, a scale…idk what else I’m just shooting from the hip and theorizing.
 
So Lyophilized powder is more than you might think, those 60mg contain more than just meds sometimes other stuff and fillers are added to the powder, not 100% whats inside your vial I personally would not even try.
 
Once reconstituted you could, I guess, but powders. No. The same principle applies as to not splitting medication in a capsule. Which part is filler which part is the drug? You have no idea. That is also the weight of medication not to total weight in the vial.
 
I know for a fact that some of the stuff I work with they state whats inside the vial and sometimes I come across names like Buffers are salts to help with PH, bulking agents like sucrose, mannitol so its more complex than you might think, hope this helps.
 
Hello friends…

Any thoughts on repackaging higher dose vials into lower dose vials? Like if you got a 60mg lyophilized vial and opened it up, weight out 6 10mg doses and put them into 6 new vials and sealed them up.

Sterile process is needed of course. Just curious if anybody has done it. What the pitfalls to avoid would be. What tools would be needed.

Minimum would be sterile environment/field, sterile tools for transferring and measuring powder, a scale…idk what else I’m just shooting from the hip and theorizing.
I feel like if you were just doing this for yourself and five friends just follow your normal safety protocol and using a luer lock syringe you could just use 6 separate vials and preferably 6 separate needles, and there isn't really any extra steps needed. The problem is if you wanted to save these spare vials and tell yourself there as sterile as a pharmacy unpunctuted vial.

Really alot extra work if your just going to slowly go through the 60mg by yourself I would just if I was concerned just split the amount into whatever you can use within a month per vial. If that's 6 vials for you (2.5 a week 10mg a month) go for it, but there is always risk and I would just get a smaller kit if your that low a dose. The extra vials just separate needle punctures. My personal risk tolerances is a full 12 punctures 3 months if the vial is clear and no floaters for compounded Tirzepatide. If I reconstituted it myself like I have with Reta I don't go past 6 weeks, but truthfully if I had to I would probably risk it a few weeks longer.

Biggest thing is just be using Hospira BAC water, if your concerned about sterility this is the single most important thing I would consider next to good sterile practice's like sterilizing your work area wearing gloves not touching needles and replacing them for every event.
 
I feel like if you were just doing this for yourself and five friends just follow your normal safety protocol and using a luer lock syringe you could just use 6 separate vials and preferably 6 separate needles, and there isn't really any extra steps needed. The problem is if you wanted to save these spare vials and tell yourself there as sterile as a pharmacy unpunctuted vial.

Really alot extra work if your just going to slowly go through the 60mg by yourself I would just if I was concerned just split the amount into whatever you can use within a month per vial. If that's 6 vials for you (2.5 a week 10mg a month) go for it, but there is always risk and I would just get a smaller kit if your that low a dose. The extra vials just separate needle punctures. My personal risk tolerances is a full 12 punctures 3 months if the vial is clear and no floaters for compounded Tirzepatide. If I reconstituted it myself like I have with Reta I don't go past 6 weeks, but truthfully if I had to I would probably risk it a few weeks longer.

Biggest thing is just be using Hospira BAC water, if your concerned about sterility this is the single most important thing I would consider next to good sterile practice's like sterilizing your work area wearing gloves not touching needles and replacing them for every event.
He wants to split the powder into 6 vials and use one at the time and that's a big NO NO.
 
The best thing for you, if you haven't already made the purchase, is to buy a 10mg kit. It sounds great to get a better deal per mg on these large kits until you gotta factor in safety.
 
If you've already made the deal, maybe consider keeping it in the freezer until you have titrated up to a point where you can get through it in enough time to not worry. Meanwhile, use a smaller mg'd kit.
 
He wants to split the powder into 6 vials and use one at the time and that's a big NO NO.
Yeah that's what I was feeling and I said that would be a problem, that being said I don't think it would kill him, it's just far from best practice, really some people very clearly here will use the same self reconstituted vial for 10+ weeks which is excessive for me but 🤷 IMHO if he goes about it the right way separating the vials does limit each vial to only 5 exposures the first puncture than the subsequent 4.

That being said to go five months before using your last vial sounds crazy to me if I were desperate I would go no more than 3 vials and 3 months which could be done with a 60mg if your dose is 5mg. Far and away what you, I, and others should recommend is that he save these 60mg vials for if and when he is at a higher dose and to order a more reasonable kit size for his dose.

That also being said one 60mg dose is a 3 month supply if your starting at 2.5 and tiltrate up to 5 month two and 7.5 month 3. And I lean towards the camp of no side effects & less than extreme weight loss tiltrate up for the most effect rather than waste time with the low and slow and risk losing effectively as even if you can go up when it starts becoming ineffective it seems like the trials suggest after 18months you have lost most of what your going to lose whether you tiltratied up or not.

By that method sure the first vial was a little risky stretching to 3 months but subsequently going up or even staying at 7.5 no 60mg vial will be used longer than 2 months. And if your following best practices and it's clear with no floaters I would just use one vial for 2 months rather than split into 2 different vials leading this whole idea of dose splitting for one's self useless/impractical for a different reason
 
The problem with splitting the power is that it is a compound of lots of filler and a little bit of peptide. There is no way to know if the peptide is equally distributed across all three portions after you split it. Worst case is that one vial could end up with all 60mg while the other two could be all filler.

Once you put the powder into solution with BAC water and swirl to mix really good, the peptide will be evenly dispersed and can be divided equally across 3 separate vials with confidence that they should all contact the same or close to the same dilution.

If you are following good sterile practices, your resulting solution will only have a potential exposure once during the transfer into the vial. The three vials are likely to be safe for the duration of use.

I would prefer the lower risk of pathogen infection over the risk of having 3 vials of unknown concentration.
 
The problem with splitting the power is that it is a compound of lots of filler and a little bit of peptide. There is no way to know if the peptide is equally distributed across all three portions after you split it. Worst case is that one vial could end up with all 60mg while the other two could be all filler.

Once you put the powder into solution with BAC water and swirl to mix really good, the peptide will be evenly dispersed and can be divided equally across 3 separate vials with confidence that they should all contact the same or close to the same dilution.

If you are following good sterile practices, your resulting solution will only have a potential exposure once during the transfer into the vial. The three vials are likely to be safe for the duration of use.

I would prefer the lower risk of pathogen infection over the risk of having 3 vials of unknown concentration.
I was going to say no one is suggesting that, but I double checked and your right he was suggesting actually splitting the powder a terrible idea....
100% no splitting powder reconstitute first and let it mix swirl and rest before splitting the reconstitution if one wanted to even go that far.
 
The problem with splitting the power is that it is a compound of lots of filler and a little bit of peptide. There is no way to know if the peptide is equally distributed across all three portions after you split it. Worst case is that one vial could end up with all 60mg while the other two could be all filler.

Once you put the powder into solution with BAC water and swirl to mix really good, the peptide will be evenly dispersed and can be divided equally across 3 separate vials with confidence that they should all contact the same or close to the same dilution.

If you are following good sterile practices, your resulting solution will only have a potential exposure once during the transfer into the vial. The three vials are likely to be safe for the duration of use.

I would prefer the lower risk of pathogen infection over the risk of having 3 vials of unknown concentration.
Not to mention it's highly unlikely that anyone reading this thread has a scale that would be accurate enough and in the correct setting to weigh such small amounts accurately, even if the API is perfectly distributed among the filler.
 
Splitting the powder up would be more or less impossible to do safely ( sterile ) . They are freeze dried so would immediately start absorbing atmospheric water as soon as you broke the seal which would reduce shelf life. Then you would have to accurately weigh and divide the powder using sterile equipment, in a sterile environment, ever better would be air free, and then get those tiny bits of powder back in vials all while staying sterile, which would be pretty hard at home. The odds are you would end up with a few tiny dust particles with bacteria from the air in the powder. This is not normally done by hand, there are machines for it. It makes more sense to buy smaller vials or reconstitute it and freeze or refrigerate the ones you don't need straight away. It is very unlikely that one freeze thaw cycle would cause significant peptide degradation. And much more likely to stay sterile than trying to measure out powder, even assuming the drug is evenly mixed into the powder.
 
Hello friends…

Any thoughts on repackaging higher dose vials into lower dose vials? Like if you got a 60mg lyophilized vial and opened it up, weight out 6 10mg doses and put them into 6 new vials and sealed them up.

Sterile process is needed of course. Just curious if anybody has done it. What the pitfalls to avoid would be. What tools would be needed.

Minimum would be sterile environment/field, sterile tools for transferring and measuring powder, a scale…idk what else I’m just shooting from the hip and theorizing.
Dosing would be unreliable. The bulk of the active ingredient could end up in just one vial and the rest be mostly filler. Like you could have 1 vial with 40mg and the other 5 vials with 4mg each.
 
Hello friends…

Any thoughts on repackaging higher dose vials into lower dose vials? Like if you got a 60mg lyophilized vial and opened it up, weight out 6 10mg doses and put them into 6 new vials and sealed them up.

Sterile process is needed of course. Just curious if anybody has done it. What the pitfalls to avoid would be. What tools would be needed.

Minimum would be sterile environment/field, sterile tools for transferring and measuring powder, a scale…idk what else I’m just shooting from the hip and theorizing.
No wouldn't do it. Risk contamination etc. Just pin more, problem solved, lol. ;-)
 
Ok. I haven’t purchased yet- well, I have purchase a 10 kit from Binh, but until it arrives I don’t view it as purchased. So this is more of a thought experiment or hypothetical.

Seems like there are 3 hurdles: sterility, dose drift, humidity. The septic/contrarian me says “we don’t actually know the gray sources we have solve for any of these!”

Sounds like the best path for hypothetical division of high dose vials is to reconstitute with Hospira BAC water and best sterile practice. Filter and divide into single dose vials and freeze -20c. Each dose gets only 1 freeze thaw cycle and the total batch could last about 3 months. Without a lab seems impossible.
 

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