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Study,Oct/21:Dvpmt. of 3D-Printed Dosing Platform to Aid in Zolpidem Withdrawal


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The full title of this Belgian/Italian study is "Development of a 3D-Printed Dosing Platform to Aid in Zolpidem Withdrawal Therapy".

 

https://pubmed.ncbi.nlm.nih.gov/34683977/

 

Abstract

 

The long-term use of benzodiazepine receptor agonists (BZRAs) is associated with multiple side effects, such as increased sedation, hangover or an elevated risk of dependency and abuse. Unfortunately, the long-term use of BZRAs is reaching worrying intake rates, and therefore, the need for action is high. It was demonstrated already that the overall willingness of patients for deprescription increased when a slow dose reduction scheme with the possibility for dose increase, if needed, is employed. The current study aims to develop a flexible dosing platform of zolpidem hemitartrate (ZHT) to facilitate such withdrawal therapy. As this is the first report on the extrusion and 3D printing of ZHT, its thermal behaviour and sensitivity towards photolytic degradation was characterised. It was shown that ZHT possesses multiple polymorphs and was especially prone to oxidative photolysis. Next, a variety of immediate release polymers (Eudragit EPO, Kollidon VA64, Kollidon 12PF and Soluplus) were blended and extruded with Polyox WSR N10 to investigate their feedability and printability by mechanical and rheological analysis. The addition of PEO was shown to enable printing of these brittle pharmaceutical polymers, although the processing temperature was deemed critical to avoid surface defects on the resulting filaments. An EPO(70)PEO(30) system was selected based on its suitable mechanical properties and low hygroscopicity favoring ZHT stability. The matrix was blended with 1% or 10% API. The effect of certain printing parameters (caplet size, nozzle diameter, % overlap) on dissolution behaviour and caplet weight/dimensions/quality was assessed. A flexible dosing platform capable of delivering <1 mg and up to 10 mg of ZHT was created. Either caplet modification (incorporation of channels) or disintegrant addition (Primojel, Explotab, Ac-Di-Sol, Primellose and Polyplasdone-XL) failed to achieve an immediate release profile. This study provides the first report of a 3D-printed flexible dosing platform containing ZHT to aid in withdrawal therapy.

 

Full Paper:

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8541164/

 

 

 

 

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Greetings and salutations, Lapis2.

 

By jove, you’ve done it again — discovered and shared a highly relevant, good news research paper with our community! Your continued efforts to keep us up-to-date on the biomedical literature regarding benzodiazepines are much appreciated.

 

As we all know, one of the most vexing problems of benzodiazepine withdrawal is the lack of flexible dosing options. The authors of this paper recognize this and have devised a promising solution.  I wonder if they are aware of Tapering Strips (link below)?

 

Tapering Strips

https://www.taperingstrip.com/

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Hi Libertas,

I'm glad to share good news, when there is some!

 

By the way, I've just added a link to the full paper, in case anyone wants to read more details.

 

:)

 

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Hi Lapis2.  You do a grand job!  Thank you for adding that link.  The paper is a tad technical, but the concept is simple — use 3D printing technology to make custom doses.
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My pleasure. Most of us who already tapered were on our own. I just followed the Ashton Manual and hoped for the best. I wasn't on BB at the time either. There are more resources available now, but people don't always have access to them or know what to do.
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