Fimaporfin
Hi
This is more for supporting Snøffelen earlier statement regarding stability and robustness of fimaporfin in terms of storage, shipment ...etc, below you ll find a link to read on technical information of Fimaporfin
https://www.medkoo.com/products/5474
Appearance: Solid powder
Purity: >98% (or refer to the Certificate of Analysis)
Shipping Condition: Shipped under ambient temperature as non-hazardous chemical. This product is stable enough for a few weeks during ordinary shipping and time spent in Customs.
Storage Condition: Dry, dark and at 0 - 4 C for short term (days to weeks) or -20 C for long term (months to years).
Solubility: Soluble in DMSO, not in water
Shelf Life: >2 years if stored properly
Drug Formulation: This drug may be formulated in DMSO
Stock Solution Storage: 0 - 4 C for short term (days to weeks), or -20 C for long term (months).
Harmonized System Code: 293490
This is also interesting:
“PCI using TPCS(2a) was shown to be very effective, and a synergistic increase in saporin toxicity was achieved in HN5 cells where viability was significantly reduced after light exposure compared to saporin (25 nM) treatment alone. The results demonstrate the favourable photophysical and photobiological properties of TPCS(2a) for PCI, which induces the relocalisation of a macromolecular anti-cancer toxin inside cells and significantly enhances cell death. ( Photochem Photobiol Sci. 2013 Mar;12(3):519-26.)”
This is more for supporting Snøffelen earlier statement regarding stability and robustness of fimaporfin in terms of storage, shipment ...etc, below you ll find a link to read on technical information of Fimaporfin
https://www.medkoo.com/products/5474
Appearance: Solid powder
Purity: >98% (or refer to the Certificate of Analysis)
Shipping Condition: Shipped under ambient temperature as non-hazardous chemical. This product is stable enough for a few weeks during ordinary shipping and time spent in Customs.
Storage Condition: Dry, dark and at 0 - 4 C for short term (days to weeks) or -20 C for long term (months to years).
Solubility: Soluble in DMSO, not in water
Shelf Life: >2 years if stored properly
Drug Formulation: This drug may be formulated in DMSO
Stock Solution Storage: 0 - 4 C for short term (days to weeks), or -20 C for long term (months).
Harmonized System Code: 293490
This is also interesting:
“PCI using TPCS(2a) was shown to be very effective, and a synergistic increase in saporin toxicity was achieved in HN5 cells where viability was significantly reduced after light exposure compared to saporin (25 nM) treatment alone. The results demonstrate the favourable photophysical and photobiological properties of TPCS(2a) for PCI, which induces the relocalisation of a macromolecular anti-cancer toxin inside cells and significantly enhances cell death. ( Photochem Photobiol Sci. 2013 Mar;12(3):519-26.)”
Redigert 20.01.2021 kl 10:14
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fabian2
15.08.2018 kl 23:17
2203
Thanks…! . Wonderful to have people like U writing here , you give us useful info almost every day :)
Stock DZ
16.08.2018 kl 11:37
1987
Snøffelen was kind enough to post this on tekinvestor today in response to my post on fimaporfin:
Snøffelen:
StockDZ said:
"This is more for supporting Snøffelen earlier statement on HO regarding stability and robustness of fimaporfin in terms of storage, shipment …etc, below you ll find a link to read on technical information of Fimaporfin
https://www.medkoo.com/products/5474 "
Just some corrections here. Fimaporfin is the drug substance (DS) or active pharmaceutical ingredient (API) in the drug product (DP) Amphinex.
Fimaporfin is a dry powder, but Amphinex is a formulation containg choosen ingredients to have certain properties.
Even if a drug substance is stable and have long shelf life, in room temperature, a drug substance in a drug product formulation do not have to.
The beauty of the API Fimaprofin is that is is very stable and easily handled also in its formulation or drug product (Amphinex).
The Amphinex formulation you can find here:
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2018069536&recNum=1&maxRec=70&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=amphinex&tab=PCTDescription 2
“Vehicle for Amphinex: 3 % Tween-80; 2.8 % mannitol; 50 mM Tris pH 8.5”
Tween-80 is a emulsifier which probably helps the solution to be stable and helps problably Amphinex to be dissolved, and stay dissolved., until administraion
https://en.m.wikipedia.org/wiki/Polysorbate_80
mannitol is a very normal excipient in very many pharmaceutical formulations. Mannitol is a naturally occurring sugar alcohol used clinically primarily for its osmotic diuretic properties.
And TRIS is a buffer to balance pH.
https://en.m.wikipedia.org/wiki/Polysorbate_80
In other words, the Amphinex solution contains very normal excipients, and Fimaporfin is very stable in that solution.
The mere fact that the solution can be autoclaved and is stable in room temperature says quite a bit. It is probably stable in many years, also the fimaVACC-application.
Remember, many vaccines must be stored at 80 minus and must be used within hours after taken out of the freezer.
Also, even a drug substance can easily be more unstable in a solution than in its dry form, excipients can help stabilize the API.
For example indicates PCIBs results for Amphinex that fimaporfin is far more stable in its Amphinex formulation than in its dry pure form.
Other things can also be difficult to understand. Your link says that fimaporfin can not be dissolved in water, but can be dissolved in DMSO.
But a liqiud drug product for intravenous injection must of course be dissolved in water, an Amphinx is obviously and of course in water.
If you heat fimaporfin in a water solution under pressure it can often be dissolved anyway, and adding different excipients also hepls to dissolve.
Much chemistry here, the main point is however that that Amphinex solution has excellent stablity in room temperature.
Snøffelen:
StockDZ said:
"This is more for supporting Snøffelen earlier statement on HO regarding stability and robustness of fimaporfin in terms of storage, shipment …etc, below you ll find a link to read on technical information of Fimaporfin
https://www.medkoo.com/products/5474 "
Just some corrections here. Fimaporfin is the drug substance (DS) or active pharmaceutical ingredient (API) in the drug product (DP) Amphinex.
Fimaporfin is a dry powder, but Amphinex is a formulation containg choosen ingredients to have certain properties.
Even if a drug substance is stable and have long shelf life, in room temperature, a drug substance in a drug product formulation do not have to.
The beauty of the API Fimaprofin is that is is very stable and easily handled also in its formulation or drug product (Amphinex).
The Amphinex formulation you can find here:
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2018069536&recNum=1&maxRec=70&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=amphinex&tab=PCTDescription 2
“Vehicle for Amphinex: 3 % Tween-80; 2.8 % mannitol; 50 mM Tris pH 8.5”
Tween-80 is a emulsifier which probably helps the solution to be stable and helps problably Amphinex to be dissolved, and stay dissolved., until administraion
https://en.m.wikipedia.org/wiki/Polysorbate_80
mannitol is a very normal excipient in very many pharmaceutical formulations. Mannitol is a naturally occurring sugar alcohol used clinically primarily for its osmotic diuretic properties.
And TRIS is a buffer to balance pH.
https://en.m.wikipedia.org/wiki/Polysorbate_80
In other words, the Amphinex solution contains very normal excipients, and Fimaporfin is very stable in that solution.
The mere fact that the solution can be autoclaved and is stable in room temperature says quite a bit. It is probably stable in many years, also the fimaVACC-application.
Remember, many vaccines must be stored at 80 minus and must be used within hours after taken out of the freezer.
Also, even a drug substance can easily be more unstable in a solution than in its dry form, excipients can help stabilize the API.
For example indicates PCIBs results for Amphinex that fimaporfin is far more stable in its Amphinex formulation than in its dry pure form.
Other things can also be difficult to understand. Your link says that fimaporfin can not be dissolved in water, but can be dissolved in DMSO.
But a liqiud drug product for intravenous injection must of course be dissolved in water, an Amphinx is obviously and of course in water.
If you heat fimaporfin in a water solution under pressure it can often be dissolved anyway, and adding different excipients also hepls to dissolve.
Much chemistry here, the main point is however that that Amphinex solution has excellent stablity in room temperature.