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How do I plan for a dulaglutide supply interruption without stockpiling badly?

Asked 17 Apr 2024Modified 2.0 years agoViewed 25k times
11

This is a recurring problem with one particular shipping lane rather than a one-off.

I am trying to build something sustainable rather than something thorough that I will abandon.

I have already decided the broad direction; this is about the specifics.

How would you structure this, and what thresholds would you set in advance?

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DV
askedDr_Bram_Verhoeven84k24817 Apr 2024

5 Answers

Accepted answer first, then by votes
33

Accepted answer

The short version: powder in the freezer or fridge, reconstituted in the fridge for weeks, and never anything on a windowsill.

Position matters less than people think: upright or on its side makes no difference to a lyophilised powder, and upright is marginally better for a reconstituted vial because it keeps the stopper dry.

Reported and extrapolated stability by condition

StateConditionUsable windowBasis
Lyophilised solid−20 °C, sealed, dry24–36 monthsSupplier guidance
Lyophilised solid2–8 °C, sealed12–24 monthsSupplier guidance
Lyophilised solid25 °C, sealed4–8 weeksExtrapolated (Arrhenius)
Lyophilised solid40 °C, sealed1–2 weeksExtrapolated
Solution, preserved2–8 °C28 daysUSP microbiological convention
Solution, preserved25 °C3–7 daysExtrapolated
Solution, unpreserved2–8 °C24 hoursUSP microbiological convention

Windows for the solid state are chemical; windows for solution are microbiological and usually shorter than the chemical limit.

Lyophilised powder: refrigerated at two to eight degrees for months, frozen at minus twenty for longer. The gain from minus eighty over minus twenty is small for a dry solid and is not usually worth the arrangement.

Residual moisture is the dominant determinant of solid-state stability, which is why desiccants accompany lyophilised material.

Equilibrate before opening or you condense water into the cake.

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MF
answered · acceptedmeniscus_film32k2719 Apr 2024
7Confirming that opening a cold vial in a humid room is a genuinely bad idea. – tandem_gradient 4 months ago
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29

Answering this needs the intended duration, since a fortnight and two years call for different arrangements.

Store with the desiccant sachet if one was supplied, inside the secondary container rather than loose in a drawer. Residual moisture is the dominant variable in solid-state stability.

Label the vial at reconstitution with the date, the concentration and the resulting units per dose. This is the single most useful thirty seconds in the whole process.

Photodegradation of tryptophan-containing peptides is documented and is the basis for light-protected storage recommendations.

Label the vial at reconstitution with date, concentration and units per dose.

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EL
answeredesben_lykke84k1586 Aug 2024
3Same experience here, different supplier. – amara_nwachukwu 7 months ago
4Is there a reason to prefer minus eighty here, or is minus twenty genuinely enough? – Dr_Ilse_Vandenberg 8 months ago
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13

On the detail: this is the tag where the advice is cheapest to follow and most often ignored.

Reconstituted with a preservative-containing diluent: refrigerated, conventionally treated as usable for about 28 days from first entry. Without a preservative, single use and discard.

Let a refrigerated or frozen vial equilibrate to room temperature before opening, so humid air does not condense water onto a cold cake.

Nothing here is medical advice, and research-use compounds are not approved for human use.

Keep the desiccant with the vial and the certificate with the lot code.

edited 21 May 2024 by rota_site — corrected a unit error in the worked example

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RS
answeredrota_site36k2712 May 2024
12

Desiccant matters more than the last few degrees of cold for a lyophilised powder.

Keep the certificate with the vial, physically or as a photograph filed under the lot code. A vial without a traceable certificate is an anonymous vial regardless of where it came from.

The 28-day in-use period for preservative-containing multi-dose preparations is printed on the diluent labelling and is a long-standing pharmacy convention.

The caveat is that storage conditions preserve what you have and cannot improve it.

Dry, cold, dark, still. Four words and you have the answer.

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EL
answeredesben_lykke84k15823 Jun 2024
4I would add a sentence about light, since tryptophan-containing sequences care. – harriet_lonsdale 5 months ago
5Thank you — this is the answer I was looking for. – Dr_Signe_Baldursdottir 7 months ago
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-3

Start with the physical state, because lyophilised and reconstituted material have completely different storage answers.

Keep vials in their original carton or in an opaque box. Light exposure matters for tryptophan-containing sequences and for anything with a chromophore, and a closed box is free.

Two-to-eight-degree refrigeration and minus-twenty freezing are the standard storage conditions for lyophilised peptides in supplier documentation across the market.

Appearance does not indicate stability; a normal-looking cake can be substantially degraded.

Minus eighty buys very little over minus twenty for a dry solid.

edited 21 May 2024 by mass_shift_18 — added a caveat about sampling

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M1
answeredmass_shift_189.7k1530 Apr 2024
7This should be linked from the help pages. – Dr_Malik_Osei 3 months ago
6The desiccant point is under-appreciated and costs nothing to act on. – h_pergande 2 months ago
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Your answer

Ask PeptideStack is a static archive. Posting is closed, but the norms are worth stating: answer the question that was asked, show your working, cite the trial or the certificate, and say plainly where the evidence runs out.

Not medical advice. Research-use-only compounds are not approved for human use.