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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Prefilled testosterone syringes: rubber plunger bloating!
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<blockquote data-quote="tareload" data-source="post: 247945"><p>Devil is in the details. Don't prefill syringes unless you understand the details.</p><p></p><p></p><p>[URL unfurl="true"]https://drugdeliverysystems.bd.com/products/prefillable-syringe-systems/add-ons-and-components/plunger-stoppers[/URL]</p><p></p><p>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.</p><p></p><p></p><p>[URL unfurl="true"]https://www.sciencedirect.com/science/article/abs/pii/S0939641119300918?via%3Dihub[/URL]</p><p></p><p>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 <a href="https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/diluent" target="_blank">diluent</a> (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 <a href="https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/benzyl-alcohol" target="_blank">benzyl alcohol</a>. 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.</p><p></p><p></p><p>[ATTACH=full]29838[/ATTACH]</p></blockquote><p></p>
[QUOTE="tareload, post: 247945"] Devil is in the details. Don't prefill syringes unless you understand the details. [URL unfurl="true"]https://drugdeliverysystems.bd.com/products/prefillable-syringe-systems/add-ons-and-components/plunger-stoppers[/URL] 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. [URL unfurl="true"]https://www.sciencedirect.com/science/article/abs/pii/S0939641119300918?via%3Dihub[/URL] 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 [URL='https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/diluent']diluent[/URL] (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 [URL='https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/benzyl-alcohol']benzyl alcohol[/URL]. 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. [ATTACH type="full"]29838[/ATTACH] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone Basics & Questions
Prefilled testosterone syringes: rubber plunger bloating!
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