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ForumsCompounding & FormulationCompounded peptide reconstitution water — looking for input

Compounded peptide reconstitution water — looking for input

maria_elpaso Fri, Oct 18, 2024 at 11:14 PM 33 replies 2,392 viewsPage 1 of 7
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maria_elpaso
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Oct 18, 2024 at 11:14 PM#1

Read the primary source rather than the write-up and the two do not agree, so here is what is actually in it.

Dead space is the answer to the missing dose. A fixed-needle insulin syringe holds a few microlitres in the hub and needle after the plunger bottoms out, and on small draws that is a measurable percentage of every dose. Across ten draws it adds up to most of an eleventh, which is exactly the "nine draws from a ten-dose vial" complaint. Luer-lock syringes are worse; low-dead-space fixed-needle designs are better.

Where I think it is weakest: the subgroup findings are the part I trust least — with enough subgroups something is always significant, and these were not all pre-registered.

The narrow version of the question is how to check the arithmetic without trusting a website calculator, since three calculators gave me three answers. I would rather have one careful answer than five confident ones.

Note on sourcing:
Figures above are from the primary publication rather than the press summary. If a number here disagrees with one you have, post yours and we will work out which of us is reading a secondary source.
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InsuranceTom
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Oct 18, 2024 at 11:22 PM#2
maria_elpaso said:
Dead space is the answer to the missing dose.

Agreeing with maria_elpaso, and the qualification matters more than the agreement. Do it in two steps and it stops being confusing. First concentration: 10mg into 2ml is 5mg/ml. Then volume: a 0.5mg dose is 0.5 ÷ 5 = 0.1ml. Then units, and this is where people go wrong — a U-100 syringe is graduated in hundredths of a millilitre, so 0.1ml is 10 units. The word "units" has nothing to do with milligrams; it is a volume marking that exists because insulin happens to come at 100 units per ml.

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FDA_TrackerJim
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Oct 18, 2024 at 11:30 PM#3
maria_elpaso said:
Dead space is the answer to the missing dose.

I am going to disagree with reconstituting low as a general rule. More diluent, more punctures, more in-use days at room temperature, and the stability trade-off is real. Precision is not the only variable being optimised.

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Dr.ObesityMed
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Oct 18, 2024 at 11:38 PM#4

Answering the narrow version, because the broad one does not have a single answer. Concentration choice is a precision decision, not a preference. Reconstitute high and every dose is a tiny volume where one unit of syringe error is a large fraction of the dose. Reconstitute low and you get more graduations per dose, so the same hand tremor costs proportionally less. Against that, more diluent means more benzyl alcohol and a shorter comfortable in-use window.

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TomTeleRx
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Oct 19, 2024 at 12:18 AM#5
InsuranceTom said:
Do it in two steps and it stops being confusing.

Same position here, arrived at the long way round. Worth adding the genuine exception, because it is real and narrow: a change made for an identified patient where the prescriber determines it produces a significant clinical difference for that patient. A grid of fixed doses offered to everybody is not that, whatever the intake form says.

If somebody has the primary source to hand I would rather cite it than paraphrase it.

Last edited: Oct 19, 2024 at 1:18 AM
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