Prefilled testosterone syringes: rubber plunger bloating!

[chriskchris]

Hi everyone.

Noticed on this forum some talk in the archives about prefilled syringes. Well, it has been something I have been doing for numerous years at times without realizing it was wrong. Below you can see a picture of a syringe filled with cypionate about two weeks ago, now showing great expansion (left side) compared to a syringe just out of the wrap. Needless to say I will waste an entire 10ml vial of cypionate as I won't be injecting rubber. Not sure if this is contributed to the loss of potency or seemingly sudden failure of cypionate on my end after years but it is something I will be eliminating from the HRT routine.

 

[Cataceous]

A lot of guys do it, but this is a good illustration of why it may not be such a good idea. Although the swelling of the stopper doesn't necessarily imply contamination, the interaction is concerning enough that I think you're wise to err on the side of caution. I've seen that ethyl oleate can do something similar to vial stoppers made from the "wrong" material.

 

[tareload]

Devil is in the details. Don't prefill syringes unless you understand the details.

Drug Delivery Systems

BD offers pharmaceutical and biotech companies a broad range of drug delivery solutions and services to help achieve goals

drugdeliverysystems.bd.com

The BD SCF™ PremiumCoat™* Plunger Stopper features a bromobutyl rubber formulation (6720GC)3 and incorporates a fluropolymer coating - Ethylene tetrafluoroethylene (ETFE)3. The quality of these stoppers** is verified, in part, using BD Visioguard™ 100% camera inspection to help reduce the risk of foreign matter contaminationμ4.

Investigation of drug product and container-closure interactions: A case study of diluent containing prefilled syringe

Prefilled syringes (PFS) constitute a widely used medical device for drug delivery particularly for the drugs of biological origin. Interactions betwe…

www.sciencedirect.com

Prefilled syringes (PFS) constitute a widely used medical device for drug delivery particularly for the drugs of biological origin. Interactions between the product contents and the components of the PFS play a critical role in determining the suitability of selected PFS. A diluent (with benzyl alcohol/BzOH as a preservative) containing PFS used for reconstitution of the lyophilized product revealed a systematic decrease in the BzOH content during accelerated and stress stability program. Investigation was carried out to understand and identify the underlying causes of this phenomenon. BzOH has a varying propensity to bind to the rubber components (stopper and tip-cap) of the PFS. Vapor permeation behavior across the tip-cap of the PFS was studied via headspace-gas chromatography-mass spectroscopy (HS-GC-MS) enabled analysis. Depending on the properties of the rubber components, BzOH can not only bind but also traverse across them, resulting in a systematic loss during the course of the stability. PFS can allow not only water vapor permeation across the tip-cap as shown in previous studies, but also molecules like benzyl alcohol. This phenomenon stresses the need for careful selection of the components of the primary packaging and also provides an opportunity to deploy novel tools like HS-GC-MS in the early selection of the optimal primary packaging configuration.

 

[tareload]

FDA notifies that Becton-Dickinson replaced rubber stoppers

FDA notifies health care professionals that Becton-Dickinson replaced problematic rubber stoppers in its syringes

www.fda.gov

 

[tareload]

Identification of an Oxidizing Leachable from a Clinical Syringe Rubber Stopper

Leaching of toxic or reactive chemicals from polymeric materials can adversely affect the quality and safety of biopharmaceuticals.It was therefore th…

www.sciencedirect.com

 

[tareload]

https://pqri.org/wp-content/uploads/2015/11/Ruberto.pdf

 

[tareload]

Thread 'Keeping testosterone in pre-loaded syringe for a week or more' Keeping testosterone in pre-loaded syringe for a week or more

 

[tareload]

elow you can see a picture of a syringe filled with cypionate about two weeks ago, now

What is the composition and source of the testosterone cypionate referenced above? What other ingredients? BA, BB, oil, etc?

 

[tareload]

https://www.pda.org/docs/default-source/pda-europe-education-presentations/2019/201910allaboutpfs/02-02-plunger-stopper-needle-shields-tip-caps.pdf?sfvrsn=5bea6581_2

 

[madman]

Hi everyone.

Noticed on this forum some talk in the archives about prefilled syringes. Well, it has been something I have been doing for numerous years at times without realizing it was wrong. Below you can see a picture of a syringe filled with cypionate about two weeks ago, now showing great expansion (left side) compared to a syringe just out of the wrap. Needless to say I will waste an entire 10ml vial of cypionate as I won't be injecting rubber. Not sure if this is contributed to the loss of potency or seemingly sudden failure of cypionate on my end after years but it is something I will be eliminating from the HRT routine.



View attachment 29824

Never heard of anyone pre-loading 3 ml syringes on trt and storing them for 2 weeks at a time for that dare I say stone-aged 200 mg/mL injection every 14 days protocol!

Look up the PKs (TC/TE).

You would have been far better off using a much lower weekly dose of T and injecting more frequently.

Many that choose the more frequent injection protocol (EOD or daily) are following a low-dose protocol.

If anything most men on trt that are preloading syringes would be those that are injecting more frequently (EOD/daily) using lower volumes of the oily solution and would most likely be using a .5 ml (50 unit) or .3 mL (30 unit) LDS insulin syringe (fixed needle).

Mind you there are also some men injecting the high-end 150-200 mg/week T split EOD or even daily.

Let alone it would be far more common to pre-load a week's worth, not 2!

Where are all those pics on the forum of those .5/.3 mL pre-loaded insulin syringes (5-14 units esterified T) with the bloated/degraded stoppers?

The BD link was already posted in this thread!

Keeping testosterone in pre-loaded syringe for a week or more

I get mine like this, they come in the 1ml ampoule and I only take 0,5 and the doc told me to discard the rest. I was thinking to save the rest for next pin in a syringe. How safe is that and is anyone doing that?

www.excelmale.com

*Of course, there are differences in some of the materials used between preloaded syringes and Luer lock hub, polypropylene slip hub, and fixed insulin syringes but when it comes to the materials used for the plunger rubber tip most of the large syringe manufacturing companies are using materials designed for:

BD Plunger Stoppers - BD

*Biocompatibility; toxicology; and extractable, leachable, and pharmacopeia compliance

 

[madman]

 

[lukdiver]

Been back-filling Easy-Touch insulin syringes for a year now. Just looked at the ones I have racked up (I do 7-8 at a time) and as I inject EOD some are 2wks old before I use them up. Don't see any swelling comparing a empty syringe.

 

[chriskchris]

What is the composition and source of the testosterone cypionate referenced above? What other ingredients? BA, BB, oil, etc?

Listed other ingredients: benzyl alcohol (as preservative), benzyl benzoate, cottonseed oil
Brand: Taro Testosterone (cypionate 100mg/1ml)

 

[BJE]

I inject testosterone cypionate with insulin syringes. I don’t pre fill them but frequently by the time I have them filled, which takes a few minutes, the rubber has already expanded and it’s hard to push the plunger in when I inject.

 

[BJE]

Never heard of anyone pre-loading 3 ml syringes on trt and storing them for 2 weeks at a time for that dare I say stone-aged 200 mg/mL injection every 14 days protocol!

Look up the PKs (TC/TE).

You would have been far better off using a much lower weekly dose of T and injecting more frequently.

Many that choose the more frequent injection protocol (EOD or daily) are following a low-dose protocol.

If anything most men on trt that are preloading syringes would be those that are injecting more frequently (EOD/daily) using lower volumes of the oily solution and would most likely be using a .5 ml (50 unit) or .3 mL (30 unit) LDS insulin syringe (fixed needle).

Mind you there are also some men injecting the high-end 150-200 mg/week T split EOD or even daily.

Let alone it would be far more common to pre-load a week's worth, not 2!

Where are all those pics on the forum of those .5/.3 mL pre-loaded insulin syringes (5-14 units esterified T) with the bloated/degraded stoppers?

I inject both testosterone cypionate and HCG every three days using .5ml insulin syringes with 31g 6mm needles. The rubber starts to swell as soon as the oil hits it. The plunger doesn’t like to stay out on its own for filling but soon after the oil hits the rubber it stays in place and occasionally I can barely get it injected because of the stiffness of the plunger.

 

[Gladiator]

 

[Jed Dorsey]

Been back-filling Easy-Touch insulin syringes for a year now. Just looked at the ones I have racked up (I do 7-8 at a time) and as I inject EOD some are 2wks old before I use them up. Don't see any swelling comparing an empty syringe.

I do the same and no stopper swelling here. The OP didn’t mention the temperature he stores them at that maybe the culprit