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Revgenetics Tween 80 Micro Res Caps


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#31 AHE

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Posted 16 December 2008 - 05:47 AM

Is this study available on the Sirtris site?

I just can't find it... could you please give me the link to the full study?

thanks

#32 maxwatt

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Posted 17 December 2008 - 05:45 AM

Is this study available on the Sirtris site?

I just can't find it... could you please give me the link to the full study?

thanks

I think you are referring to the patent Anthony got his graphs from, USPTO Document #20060292099. The study was done in mice, whose metabolism is a bit different from humans. I believe the original Sirt1 formulation was done with Tween80, but later versions used HPMC instead, and DOSS as a stabilizer. Maybe they have some unpublished data in humans, or went with HPMC for other reasons.

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#33 smithx

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Posted 30 December 2008 - 09:58 AM

I wonder if Sirtis decided on HPMC due to Tween 80's possibly damaging effects.

5mg/kg of HPMC was proposed as a max intake per day in this study.

Polysorbate 80, according to [url="http://"cosmetics%20database%20<a%20href="http://www.cosmeticsdatabase.com/ingredient.php?ingred06=705142&refurl=/product.php?prod_id=20738&&nothanks=1""%20target="_blank">http://www.cosmetics...ien...othanks=1"</a>"]Cosmetics Database[/url], has a lot of bad effects in animals, and is limited to less than 175 mg/day as a food additive by the FDA.

Edited by smithx, 30 December 2008 - 09:58 AM.


#34 smithx

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Posted 30 December 2008 - 11:09 AM

I notice that Vivix seems to be using sorbitol as a solvent.

If this works, it would be preferable since sorbitol is naturally occurring in the body.

It may be that it has a low solubility for resveratrol, however, which could be one reason that Vivix has a fairly low concentration of resveratrol.

Anyone have data on this?

#35 drmz

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Posted 30 December 2008 - 11:48 AM

I wonder if Sirtis decided on HPMC due to Tween 80's possibly damaging effects.

5mg/kg of HPMC was proposed as a max intake per day in this study.

Polysorbate 80, according to [url="http://"cosmetics%20database%20<a%20href="http://www.cosmeticsdatabase.com/ingredient.php?ingred06=705142&refurl=/product.php?prod_id=20738&&nothanks=1""%20target="_blank">http://www.cosmetics...ien...othanks=1"</a>"]Cosmetics Database[/url], has a lot of bad effects in animals, and is limited to less than 175 mg/day as a food additive by the FDA.


Are you refering to this study smithx (possible damaging effects ?) , btw above link is not working.

http://www.cosmetics...ingred06=705137 Tween 20
http://www.cosmetics...ingred06=705142 Tween 80


Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways.Kerwin BA.
Department of Pharmaceutics, Amgen Inc., One Amgen Center Dr., Thousand Oaks, California 91320, USA. bkerwin@amgen.com

Polysorbates 20 and 80 (Tween 20 and Tween 80) are used in the formulation of biotherapeutic products for both preventing surface adsorption and as stabilizers against protein aggregation. The polysorbates are amphipathic, nonionic surfactants composed of fatty acid esters of polyoxyethylene sorbitan being polyoxyethylene sorbitan monolaurate for polysorbate 20 and polyoxyethylene sorbitan monooleate for polysorbate 80. The polysorbates used in the formulation of biopharmaceuticals are mixtures of different fatty acid esters with the monolaurate fraction of polysorbate 20 making up only 40-60% of the mixture and the monooleate fraction of polysorbate 80 making up >58% of the mixture. The polysorbates undergo autooxidation, cleavage at the ethylene oxide subunits and hydrolysis of the fatty acid ester bond. Autooxidation results in hydroperoxide formation, side-chain cleavage and eventually formation of short chain acids such as formic acid all of which could influence the stability of a biopharmaceutical product. Oxidation of the fatty acid moiety while well described in the literature has not been specifically investigated for polysorbate. This review focuses on the chemical structure of the polysorbates, factors influencing micelle formation and factors and excipients influencing stability and degradation of the polyoxyethylene and fatty acid ester linkages.

(better subscribe to imminst again so i can request the full study

Edited by drmz, 30 December 2008 - 11:51 AM.


#36 Anthony_Loera

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Posted 30 December 2008 - 03:17 PM

I wonder if Sirtis decided on HPMC due to Tween 80's possibly damaging effects.

5mg/kg of HPMC was proposed as a max intake per day in this study.

Polysorbate 80, according to [url="http://"cosmetics%20database%20<a%20href="http://www.cosmeticsdatabase.com/ingredient.php?ingred06=705142&refurl=/product.php?prod_id=20738&&nothanks=1""%20target="_blank">http://www.cosmetics...ien...othanks=1"</a>"]Cosmetics Database[/url], has a lot of bad effects in animals, and is limited to less than 175 mg/day as a food additive by the FDA.



The main issue with Polysorbate 80 is when it is injected, not when taken orally in a pill, or in ice cream. It is included in an enormous amount of foods in your supermarket and the FDA doesn't find an issues with it. It is considered GRAS, and used in many foods typically eaten by children .

The database you refer to, has it with a very low rating of 2 (out of 10) with 10 being of high concern.

As a comparison, the database also rates the following as the same or worse:

PEG-40 HYDROGENATED CASTOR OIL has a much higher rating of 4-6 depending on the product.
NIACINAMIDE has rating of 2
CITRIC ACID (VITAMIN C) has a rating of 4
VITAMIN A has a rating of 2
MICRONIZED ZINC OXIDE has a rating of 2-5 depending on the product
ZEA MAYS (CORN) OIL (VITAMIN D3) has a rating of 2
VITAMIN D has a rating of 3
VITAMIN D2 has a rating of 5

Again, we don't suggest opening the capsule and injecting yourself with the contents, but we do believe it is completely safe when taken orally, as you would normally do with supplements.

Cheers
A

#37 smithx

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Posted 31 December 2008 - 12:12 AM

Again, we don't suggest opening the capsule and injecting yourself with the contents, but we do believe it is completely safe when taken orally, as you would normally do with supplements.


Thanks Anthony, but given the FDA max recommended dose of 175mg/day, how much is in your capsules?

Also, what about considering using sorbitol as a solvent?

#38 Anthony_Loera

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Posted 31 December 2008 - 03:27 AM

Smithx,

again we have no problems with the FDA maximum recommended dose.



Cheers
A

Edited by Anthony_Loera, 31 December 2008 - 03:43 AM.


#39 drmz

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Posted 31 December 2008 - 07:17 AM

Seems like you need alot more of tween 80 then in the revgenetic caps to do any harm :

Evaluation of developmental neurotoxicity of polysorbate 80 in rats

The developmental neurotoxicity of polysorbate 80 (PS80) was evaluated in rats. Crl:CD(SD) rats were given drinking water containing PS80 at 0, 0.018, 0.13, 1.0, or 7.5% (0, 0.035, 0.245, 1.864, or 16.783 ml/kg bw/day) on day 0 of pregnancy through day 21 after delivery. Pregnant rats were allowed to deliver spontaneously. Potential adverse effects of pre- and post-natal exposure on the development and function of the nervous system in offspring of rats given PS80 were examined. Maternal body weight was lowered at 7.5%. Number of pups born was lowered at 7.5%. There were no compound-related effects on locomotor activity of offspring on postnatal days (PNDs) 14–15, 17–18, 20–21 and 33–37. No compound-related changes were found in developmental landmarks, sexual maturation, or reflex responses. Although decreased rate of avoidance responses was noted on PNDs 23–27 in male and female offspring at 7.5%, no compound-related changes were found in performance in the conditioned avoidance response on PNDs 60–67. Histopathological examinations of the brain revealed no toxicological changes. Lowered body weight was observed in male and female offspring at 7.5%. The NOAEL in this study was considered to be 1.0% (1.864 ml/mg/kg bw/day).

See section 11 :

Polysorbate Material Safety Datasheet

#40 smithx

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Posted 31 December 2008 - 03:21 PM

Seems like you need alot more of tween 80 then in the revgenetic caps to do any harm :


Right, but polysorbate 80 is pretty clearly not a nice thing to be ingesting if you don't have to. And the 175mg/day FDA suggested limit is quite low, especially considering that it can be present in other things that people routinely ingest, as was pointed out (such as ice cream).

And unless I'm mistaken, we don't know how much polysorbate 80 is in one of these capsules.

Also, if resveratrol is soluble in sorbitol, which is a compound which naturally occurs in the body, that would be preferable.

#41 Anthony_Loera

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Posted 31 December 2008 - 04:07 PM

Smithx,

There is no data suggesting how much resveratrol is absorbed using sorbital,
you might as well go back to buying powder & mix in a HPMC/DOSS emulsion instead.

On the other hand the data suggesting how much resveratrol is absorbed using tween 80, certainly makes this appear to be the best method for oral delivery in a liquid capsule.

There is no issue with tween 80 being used in one or multiple capsules, unless you decide to inject it into your bloodstream. But then again, most supplements, even liquid supplements cannot be injected either, so this is a non-issue simply because of this fact. Drmz has brought up a study in his post, that we evaluated before the decision took place to make this product. He is correct, you need quite a bit for issues in mice. In other studies, it was only when tween was injected that issues arose, while oral tween had no issues.

The 175mg a day limit for a vitamin/mineral substance is a good thing, however if I were to mix it in a fat soluble substance, the FDA's requirements would go up to 300mg a day. I find it interesting how that limit changes with the FDA. Either way, the substance in our capsules is below these two requirements, even when taking multiple capsules.

I attribute the exact formulation and absorption to the Capsugel formulators, who are experienced in both supplement formulations as well as med formulations. The final formulation was not done by an inexperienced team who were not concerned about safety.

It was performed by a team who has the experience for this type of application.

Cheers
A

#42 smithx

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Posted 01 January 2009 - 12:30 AM

The 175mg a day limit for a vitamin/mineral substance is a good thing, however if I were to mix it in a fat soluble substance, the FDA's requirements would go up to 300mg a day.



I think you're misunderstanding. The 175mg/day is the FDA's recommended maximum quantity of polysorbate 80 to ingest, based on their interpretation of safety data. It's not a vitamin/mineral limit but a maximum exposure limit to a potentially harmful substance.

And I notice that you still haven't specified how much polysorbate 80 is in each of your capsules.

BTW, if you'd hire someone like Hedgehog to do a test, it would be quite easy to find absorption data for resveratrol dissolved in sorbitol. It's probable that this was done by Sinclair / Shaklee but wasn't published.

Edited by smithx, 01 January 2009 - 12:31 AM.


#43 zorba990

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Posted 01 January 2009 - 03:16 AM

The 175mg a day limit for a vitamin/mineral substance is a good thing, however if I were to mix it in a fat soluble substance, the FDA's requirements would go up to 300mg a day.



I think you're misunderstanding. The 175mg/day is the FDA's recommended maximum quantity of polysorbate 80 to ingest, based on their interpretation of safety data. It's not a vitamin/mineral limit but a maximum exposure limit to a potentially harmful substance.

And I notice that you still haven't specified how much polysorbate 80 is in each of your capsules.

BTW, if you'd hire someone like Hedgehog to do a test, it would be quite easy to find absorption data for resveratrol dissolved in sorbitol. It's probable that this was done by Sinclair / Shaklee but wasn't published.


Sorbitol is a powerful laxative. Here's an article on PEGylated liposomes
http://www.life-enha...ate.asp?ID=1097

#44 smithx

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Posted 01 January 2009 - 05:21 AM

Sorbitol is a powerful laxative. Here's an article on PEGylated liposomes
http://www.life-enha...ate.asp?ID=1097


Yes, if you take about 9gm of it or more:

http://www.cspinet.o...g_sorbitol.html

That's quite different from an advised maximum of 175mg.

#45 Anthony_Loera

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Posted 01 January 2009 - 05:02 PM

Hi smithx,

you are right, I haven't mentioned the exact amount because it is not considered an active component of the formulation.
The same reason "Sorbital" is listed without an amount on the Vivi* packaging. So we also don't know how much is used in that product.

Tell you what, if you can get the Vivi* folks to tell you how much sorbital is in vivi*, I will gladly provide you my numbers for tween 80.

I can probably bet it may be considered a trade secret...

Thanks
A

#46 Ringostarr

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Posted 01 January 2009 - 06:11 PM

Hi smithx,

you are right, I haven't mentioned the exact amount because it is not considered an active component of the formulation.
The same reason "Sorbital" is listed without an amount on the Vivi* packaging. So we also don't know how much is used in that product.

Tell you what, if you can get the Vivi* folks to tell you how much sorbital is in vivi*, I will gladly provide you my numbers for tween 80.

I can probably bet it may be considered a trade secret...

Thanks
A


The great thing about trade secrets is that they can Legally be reverse engineered. Granted, that can be a bit of trouble, but it is always possability for the curious.
Happy New Year to All!

#47 neil_patmore

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Posted 11 January 2009 - 01:16 PM

I must admit this thread has put me off the tween 80 mix.
I guess the million dollar question is 'Why did Sirtris go with HPMC/DOSS and not Tween80?'. Maybe we'll never know!

#48 Anthony_Loera

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Posted 11 January 2009 - 03:41 PM

I must admit this thread has put me off the tween 80 mix.
I guess the million dollar question is 'Why did Sirtris go with HPMC/DOSS and not Tween80?'. Maybe we'll never know!


Hi Neil,

we don't know if Sirtris went with the HPMC/DOSS and micronized resveratrol.
As far as I know the patent was for cyclodextrin and micronized resveratrol, not HPMCC/DOSS and micronized resveratrol.

Tween 80 is safe to take orally, however for vegetarians and folks who do want to make their own mixtures, bulk micronized resveratrol is available for folks to consider... and cheaper than the Tween 80 Nitrogen filled capsules on a gram per gram basis.

Cheers
A

Edited by Anthony_Loera, 11 January 2009 - 03:42 PM.


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#49 neil_patmore

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Posted 11 January 2009 - 10:50 PM

Thanks for that Anthony, I already placed an order with you yesterday for powder. ;)




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