Oral allopregnanolone coming soon to a pharmacy near you

haidut

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Kidding aside, it looks like pharma companies are starting to develop a very strong interest in oral delivery of steroids, using the technique described by Peat decades ago to bypass the first-pass metabolism in the liver. Namely, as Peat described, mixing a steroid (or another molecule) with long(er) chain fats (chain length 12 or more) enables the digestive system to incorporate said molecule and the long(er) chain fats into chylomicrons. Since the chylomicrons are too large to enter blood vessels in the GI tract, they are instead transported through the lymphatic system to the thoracic duct, at which point there are released into the systemic circulation. After claiming for more than 50 years that orally administered steroid are useless, now Big Pharma is all over this idea and several companies are working on such oral steroid formulations. Namely, an oral testosterone undecanoate (TU) formulation was recently approved by the FDA under the trade name Jatenzo. And now, this company has released a press briefing about its own pre-clinical trial with humans demonstrating that an oral formulation of allopregnanolone (AlloP) works quite well and much more bioavailable than allopregnanolone administered on its own. If approved by the FDA, they expect this new formulation (LYT-300) to be able to treat the full spectrum of neurological and psychiatric conditions. While the details on the technology are sparse, the overall principle described is the same as Jatenzo - i.e. combining the allopregnanolone with long-chain fat triglycerides so that when consumed orally, the allopregnanolone (largely) avoids the first pass metabolism through the liver and instead gets systemically delivered. In other words, Peat's approach to oral steroid delivery has been validated and is now rapidly being explored for commercial success as an alternative to IV/injection formulations. Allopregnanolone has already been approved as an injection formulation known as Zulresso, for the treatment of depression. This new company below is directly targeting not just the steroid market but potentially all other drugs currently administered by IV/injection. So, the approach of lymphatic-systemic delivery of molecules via oral route seems to be applicable to just about any molecule. The bad news about all of this is that, now that the oral-lymphatic-systemic route has been validated, I would not be surprised if many other steroids currently available as OTC supplement are soon developed as patented pharmaceutical formulations, and then taken off market by the FDA. Perhaps, this is how the FDA can go around directly banning OTC steroids such as pregnenolone, progesterone, DHEA, allopregnanolone, etc. Namely, simply wait (and maybe even encourage) for a company to develop a commercial formulation, and once said formulation is approved then all OTC analogs can be declared as unapproved prescription drugs, and withdrawn from the market by order of FDA. Let's all hope Big Pharma has bigger fish to fry and leaves (at least for now) the OTC steroids alone.

LYT-300
PureTech Presents Preclinical Proof-of-Concept Data for LYT-300 (Oral Allopregnanolone) as Potential Treatment for Neurological and Neuropsychological Conditions

"...BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced the presentation of preclinical proof-of-concept data at the 60th American College of Neuropsychopharmacology (ACNP) Annual Meeting that support the clinical advancement of LYT-300 (oral allopregnanolone), PureTech’s wholly-owned therapeutic candidate for the potential treatment of neurological and neuropsychological conditions, including depression, anxiety, sleep disorders, fragile X tremor-associated syndrome, essential tremor and epileptic disorders, among others. LYT-300 was recently advanced into a Phase 1 clinical study, which is designed to characterize the safety, tolerability and PK of orally administered LYT-300 in healthy volunteers and is expected to read out in the second half of 2022."

"...LYT-300 is an oral form of allopregnanolone. Allopregnanolone is a natural neurosteroid that is a positive allosteric modulator of γ-aminobutyric-acid type A (GABAA) receptors, which are known to play a key biological role in depression, epilepsy and other neurological and neuropsychological conditions. Natural allopregnanolone has poor oral bioavailability, thus limiting its development as a therapeutic. An injectable formulation of allopregnanolone is approved by the United States Food and Drug Administration (FDA) as a 60-hour infusion for the treatment of post-partum depression, though the method of administration has limitations. Synthetic oral analogs of allopregnanolone have had variable clinical success, and comparable activity with natural allopregnanolone remains to be established. Using PureTech’s proprietary Glyph technology platform, LYT-300 is designed to unlock the validated biology of allopregnanolone to potentially offer a new, oral treatment option for a range of conditions where there is significant patient need. The data presented at ACNP showed that systemic exposure of natural allopregnanolone was achieved after oral administration of LYT-300 in multiple preclinical models of increasing complexity. In contrast, systemic levels of allopregnanolone were not observed following oral administration of natural unmodified allopregnanolone. These results demonstrate the potential of the Glyph technology platform to enhance the systemic absorption of natural bioactive molecules and other small molecules with poor oral bioavailability."

"...Glyph is PureTech’s synthetic lymphatic-targeting chemistry platform which is designed to employ the lymphatic system’s natural lipid absorption and transport process to enable the oral administration of therapeutics. Glyph reversibly links a drug to a dietary fat molecule, creating a novel prodrug. The linked fat molecule re-routes the drug’s normal path to the systemic circulation, bypassing the liver and instead moving from the gut into the lymphatic vessels that normally process dietary fats. PureTech believes this technology has the potential to (1) enable direct modulation of the immune system via drug targets present in mesenteric lymph nodes and (2) provide a broadly applicable means of enhancing the bioavailability of orally administered drugs that would otherwise be reduced by first-pass liver metabolism. PureTech is leveraging validated biology to accelerate the development of a Glyph portfolio, prioritizing highly characterized drugs to enhance with the Glyph technology based on the potential value unlocked in improving their oral bioavailability or lymphatic targeting. "
 

Drareg

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4,772
Kidding aside, it looks like pharma companies are starting to develop a very strong interest in oral delivery of steroids, using the technique described by Peat decades ago to bypass the first-pass metabolism in the liver. Namely, as Peat described, mixing a steroid (or another molecule) with long(er) chain fats (chain length 12 or more) enables the digestive system to incorporate said molecule and the long(er) chain fats into chylomicrons. Since the chylomicrons are too large to enter blood vessels in the GI tract, they are instead transported through the lymphatic system to the thoracic duct, at which point there are released into the systemic circulation. After claiming for more than 50 years that orally administered steroid are useless, now Big Pharma is all over this idea and several companies are working on such oral steroid formulations. Namely, an oral testosterone undecanoate (TU) formulation was recently approved by the FDA under the trade name Jatenzo. And now, this company has released a press briefing about its own pre-clinical trial with humans demonstrating that an oral formulation of allopregnanolone (AlloP) works quite well and much more bioavailable than allopregnanolone administered on its own. If approved by the FDA, they expect this new formulation (LYT-300) to be able to treat the full spectrum of neurological and psychiatric conditions. While the details on the technology are sparse, the overall principle described is the same as Jatenzo - i.e. combining the allopregnanolone with long-chain fat triglycerides so that when consumed orally, the allopregnanolone (largely) avoids the first pass metabolism through the liver and instead gets systemically delivered. In other words, Peat's approach to oral steroid delivery has been validated and is now rapidly being explored for commercial success as an alternative to IV/injection formulations. Allopregnanolone has already been approved as an injection formulation known as Zulresso, for the treatment of depression. This new company below is directly targeting not just the steroid market but potentially all other drugs currently administered by IV/injection. So, the approach of lymphatic-systemic delivery of molecules via oral route seems to be applicable to just about any molecule. The bad news about all of this is that, now that the oral-lymphatic-systemic route has been validated, I would not be surprised if many other steroids currently available as OTC supplement are soon developed as patented pharmaceutical formulations, and then taken off market by the FDA. Perhaps, this is how the FDA can go around directly banning OTC steroids such as pregnenolone, progesterone, DHEA, allopregnanolone, etc. Namely, simply wait (and maybe even encourage) for a company to develop a commercial formulation, and once said formulation is approved then all OTC analogs can be declared as unapproved prescription drugs, and withdrawn from the market by order of FDA. Let's all hope Big Pharma has bigger fish to fry and leaves (at least for now) the OTC steroids alone.

LYT-300
PureTech Presents Preclinical Proof-of-Concept Data for LYT-300 (Oral Allopregnanolone) as Potential Treatment for Neurological and Neuropsychological Conditions

"...BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced the presentation of preclinical proof-of-concept data at the 60th American College of Neuropsychopharmacology (ACNP) Annual Meeting that support the clinical advancement of LYT-300 (oral allopregnanolone), PureTech’s wholly-owned therapeutic candidate for the potential treatment of neurological and neuropsychological conditions, including depression, anxiety, sleep disorders, fragile X tremor-associated syndrome, essential tremor and epileptic disorders, among others. LYT-300 was recently advanced into a Phase 1 clinical study, which is designed to characterize the safety, tolerability and PK of orally administered LYT-300 in healthy volunteers and is expected to read out in the second half of 2022."

"...LYT-300 is an oral form of allopregnanolone. Allopregnanolone is a natural neurosteroid that is a positive allosteric modulator of γ-aminobutyric-acid type A (GABAA) receptors, which are known to play a key biological role in depression, epilepsy and other neurological and neuropsychological conditions. Natural allopregnanolone has poor oral bioavailability, thus limiting its development as a therapeutic. An injectable formulation of allopregnanolone is approved by the United States Food and Drug Administration (FDA) as a 60-hour infusion for the treatment of post-partum depression, though the method of administration has limitations. Synthetic oral analogs of allopregnanolone have had variable clinical success, and comparable activity with natural allopregnanolone remains to be established. Using PureTech’s proprietary Glyph technology platform, LYT-300 is designed to unlock the validated biology of allopregnanolone to potentially offer a new, oral treatment option for a range of conditions where there is significant patient need. The data presented at ACNP showed that systemic exposure of natural allopregnanolone was achieved after oral administration of LYT-300 in multiple preclinical models of increasing complexity. In contrast, systemic levels of allopregnanolone were not observed following oral administration of natural unmodified allopregnanolone. These results demonstrate the potential of the Glyph technology platform to enhance the systemic absorption of natural bioactive molecules and other small molecules with poor oral bioavailability."

"...Glyph is PureTech’s synthetic lymphatic-targeting chemistry platform which is designed to employ the lymphatic system’s natural lipid absorption and transport process to enable the oral administration of therapeutics. Glyph reversibly links a drug to a dietary fat molecule, creating a novel prodrug. The linked fat molecule re-routes the drug’s normal path to the systemic circulation, bypassing the liver and instead moving from the gut into the lymphatic vessels that normally process dietary fats. PureTech believes this technology has the potential to (1) enable direct modulation of the immune system via drug targets present in mesenteric lymph nodes and (2) provide a broadly applicable means of enhancing the bioavailability of orally administered drugs that would otherwise be reduced by first-pass liver metabolism. PureTech is leveraging validated biology to accelerate the development of a Glyph portfolio, prioritizing highly characterized drugs to enhance with the Glyph technology based on the potential value unlocked in improving their oral bioavailability or lymphatic targeting. "
They will look to monopolize the formulae via patents and profit as you say, the bright side is allopregnenolone will be used to treat depression, this may be the end of SSRI’s, this means wokism will be in retreat, this changes everything as Tim Apple would say.

This really is huge, the neural structures being constructed by SSRI’s are starting to appear outside the brain in society, said structures are clearly mad, said structures have the capacity to turn non SSRI fueled brains mad, these structures are highly seretonergic, many peaty humans are looking for new places to live to get away, we have regular posts on here asking about it, coherency should return albeit slowly.

The cringe the SSRI induced people will go through while reflecting on past behavior while taking allopregnenolone will be real, the allo should help them get through it.
How long before we can get this in the water supply? Start with California, maybe then they will notice the homeless and their psychotic hypocrisy.
 

Atonewithme

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Kidding aside, it looks like pharma companies are starting to develop a very strong interest in oral delivery of steroids, using the technique described by Peat decades ago to bypass the first-pass metabolism in the liver. Namely, as Peat described, mixing a steroid (or another molecule) with long(er) chain fats (chain length 12 or more) enables the digestive system to incorporate said molecule and the long(er) chain fats into chylomicrons. Since the chylomicrons are too large to enter blood vessels in the GI tract, they are instead transported through the lymphatic system to the thoracic duct, at which point there are released into the systemic circulation. After claiming for more than 50 years that orally administered steroid are useless, now Big Pharma is all over this idea and several companies are working on such oral steroid formulations. Namely, an oral testosterone undecanoate (TU) formulation was recently approved by the FDA under the trade name Jatenzo. And now, this company has released a press briefing about its own pre-clinical trial with humans demonstrating that an oral formulation of allopregnanolone (AlloP) works quite well and much more bioavailable than allopregnanolone administered on its own. If approved by the FDA, they expect this new formulation (LYT-300) to be able to treat the full spectrum of neurological and psychiatric conditions. While the details on the technology are sparse, the overall principle described is the same as Jatenzo - i.e. combining the allopregnanolone with long-chain fat triglycerides so that when consumed orally, the allopregnanolone (largely) avoids the first pass metabolism through the liver and instead gets systemically delivered. In other words, Peat's approach to oral steroid delivery has been validated and is now rapidly being explored for commercial success as an alternative to IV/injection formulations. Allopregnanolone has already been approved as an injection formulation known as Zulresso, for the treatment of depression. This new company below is directly targeting not just the steroid market but potentially all other drugs currently administered by IV/injection. So, the approach of lymphatic-systemic delivery of molecules via oral route seems to be applicable to just about any molecule. The bad news about all of this is that, now that the oral-lymphatic-systemic route has been validated, I would not be surprised if many other steroids currently available as OTC supplement are soon developed as patented pharmaceutical formulations, and then taken off market by the FDA. Perhaps, this is how the FDA can go around directly banning OTC steroids such as pregnenolone, progesterone, DHEA, allopregnanolone, etc. Namely, simply wait (and maybe even encourage) for a company to develop a commercial formulation, and once said formulation is approved then all OTC analogs can be declared as unapproved prescription drugs, and withdrawn from the market by order of FDA. Let's all hope Big Pharma has bigger fish to fry and leaves (at least for now) the OTC steroids alone.

LYT-300
PureTech Presents Preclinical Proof-of-Concept Data for LYT-300 (Oral Allopregnanolone) as Potential Treatment for Neurological and Neuropsychological Conditions

"...BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced the presentation of preclinical proof-of-concept data at the 60th American College of Neuropsychopharmacology (ACNP) Annual Meeting that support the clinical advancement of LYT-300 (oral allopregnanolone), PureTech’s wholly-owned therapeutic candidate for the potential treatment of neurological and neuropsychological conditions, including depression, anxiety, sleep disorders, fragile X tremor-associated syndrome, essential tremor and epileptic disorders, among others. LYT-300 was recently advanced into a Phase 1 clinical study, which is designed to characterize the safety, tolerability and PK of orally administered LYT-300 in healthy volunteers and is expected to read out in the second half of 2022."

"...LYT-300 is an oral form of allopregnanolone. Allopregnanolone is a natural neurosteroid that is a positive allosteric modulator of γ-aminobutyric-acid type A (GABAA) receptors, which are known to play a key biological role in depression, epilepsy and other neurological and neuropsychological conditions. Natural allopregnanolone has poor oral bioavailability, thus limiting its development as a therapeutic. An injectable formulation of allopregnanolone is approved by the United States Food and Drug Administration (FDA) as a 60-hour infusion for the treatment of post-partum depression, though the method of administration has limitations. Synthetic oral analogs of allopregnanolone have had variable clinical success, and comparable activity with natural allopregnanolone remains to be established. Using PureTech’s proprietary Glyph technology platform, LYT-300 is designed to unlock the validated biology of allopregnanolone to potentially offer a new, oral treatment option for a range of conditions where there is significant patient need. The data presented at ACNP showed that systemic exposure of natural allopregnanolone was achieved after oral administration of LYT-300 in multiple preclinical models of increasing complexity. In contrast, systemic levels of allopregnanolone were not observed following oral administration of natural unmodified allopregnanolone. These results demonstrate the potential of the Glyph technology platform to enhance the systemic absorption of natural bioactive molecules and other small molecules with poor oral bioavailability."

"...Glyph is PureTech’s synthetic lymphatic-targeting chemistry platform which is designed to employ the lymphatic system’s natural lipid absorption and transport process to enable the oral administration of therapeutics. Glyph reversibly links a drug to a dietary fat molecule, creating a novel prodrug. The linked fat molecule re-routes the drug’s normal path to the systemic circulation, bypassing the liver and instead moving from the gut into the lymphatic vessels that normally process dietary fats. PureTech believes this technology has the potential to (1) enable direct modulation of the immune system via drug targets present in mesenteric lymph nodes and (2) provide a broadly applicable means of enhancing the bioavailability of orally administered drugs that would otherwise be reduced by first-pass liver metabolism. PureTech is leveraging validated biology to accelerate the development of a Glyph portfolio, prioritizing highly characterized drugs to enhance with the Glyph technology based on the potential value unlocked in improving their oral bioavailability or lymphatic targeting. "
Well L-methyl folate was still available in lower doses despite a prescription form being developed and sold by a drug company. Im sure there was another push to regulate supplements at the time. Of course, the cost was horrible for some time and I relied on free samples from my functional doc or I would have had trouble paying for any form of it.
 
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haidut

haidut

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They will look to monopolize the formulae via patents and profit as you say, the bright side is allopregnenolone will be used to treat depression, this may be the end of SSRI’s, this means wokism will be in retreat, this changes everything as Tim Apple would say.

This really is huge, the neural structures being constructed by SSRI’s are starting to appear outside the brain in society, said structures are clearly mad, said structures have the capacity to turn non SSRI fueled brains mad, these structures are highly seretonergic, many peaty humans are looking for new places to live to get away, we have regular posts on here asking about it, coherency should return albeit slowly.

The cringe the SSRI induced people will go through while reflecting on past behavior while taking allopregnenolone will be real, the allo should help them get through it.
How long before we can get this in the water supply? Start with California, maybe then they will notice the homeless and their psychotic hypocrisy.

Yep, I think the "law of unintended consequences" may apply here and eventually undermine Big Pharma precisely due to its insatiable glut for profit. They are so desperate to find any new "blockbuster" drug, considering the scam of SSRI cannot be concealed for too much longer, they may end up putting a drug on the market that actually works and leads to a higher consciousness of sorts that will allow a large number of people to simultaneously realize what kind of hell they have been living in, and immediately try to change it. It is not just allopregnanolone. Since testosterone is a also a potent antidepressant, the recent approval of Jatenzo I mentioned in the post may have similar effects, especially in males. Once beneficial steroid supplementation becomes more widespread, it would undermine several pillars of the current genocidal agenda - learned helplessness, mass psychosis, the soyboy/snowflake phenomenon, hypometabolism and all of its low-energy servile/autocratic/sociopathic personality type manifestations, etc, At that point, if enough people have woken up, the system will find it very hard to ban steroids, as everybody will be seeking and using them - i.e. it would be a failure bigger than the "War on Drugs".
 

Drareg

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Yep, I think the "law of unintended consequences" may apply here and eventually undermine Big Pharma precisely due to its insatiable glut for profit. They are so desperate to find any new "blockbuster" drug, considering the scam of SSRI cannot be concealed for too much longer, they may end up putting a drug on the market that actually works and leads to a higher consciousness of sorts that will allow a large number of people to simultaneously realize what kind of hell they have been living in, and immediately try to change it. It is not just allopregnanolone. Since testosterone is a also a potent antidepressant, the recent approval of Jatenzo I mentioned in the post may have similar effects, especially in males. Once beneficial steroid supplementation becomes more widespread, it would undermine several pillars of the current genocidal agenda - learned helplessness, mass psychosis, the soyboy/snowflake phenomenon, hypometabolism and all of its low-energy servile/autocratic/sociopathic personality type manifestations, etc, At that point, if enough people have woken up, the system will find it very hard to ban steroids, as everybody will be seeking and using them - i.e. it would be a failure bigger than the "War on Drugs".
When people inject testosterone undecanoate based in castor oil will this not increase tissue conversion to estrogen? Or maybe there is an initial inflammatory effect like PUFA that could be temporarily beneficial.
 

Shackles

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When people inject testosterone undecanoate based in castor oil will this not increase tissue conversion to estrogen? Or maybe there is an initial inflammatory effect like PUFA that could be temporarily beneficial.
But we are speaking about the spread of this certain formula based on long chained fats being integrated into chylomicrons. That would definitely trump injection-based steroids because it is easier to take a few mg of Testosterone base which would be an addition to your panel, not surpression
 

Drareg

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But we are speaking about the spread of this certain formula based on long chained fats being integrated into chylomicrons. That would definitely trump injection-based steroids because it is easier to take a few mg of Testosterone base which would be an addition to your panel, not surpression
It would trump, it may lessen estrogen conversion also, that’s why asked about PUFA mixed in with intramuscular preparations.
 
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haidut

haidut

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When people inject testosterone undecanoate based in castor oil will this not increase tissue conversion to estrogen? Or maybe there is an initial inflammatory effect like PUFA that could be temporarily beneficial.
Jatenzo is an oral T product and my comments were in regards to it, not the injectable forms that have PUFA. Since pills have the potential to become a much more mass-consumed product compared to injections, I was thinking that Jatenzo, the oral allopreganolone and any other oral steroid product with beneficial effects would quickly become very popular and replace many other mood drugs, as well as other forms of HRT, and thus could lead to a large number of people basically snapping out of their zombification. I would not be surprised if the next product to be (quietly) announced is an oral version of Andractim (DHT), and possibly pregnenolone as well. A company has already developed a patented pregnenolone version, which is nothing but a methyl ether of plain pregnenolone and has identical effects. They are also pushing it for depression, but given pregnenolone's effects on consciousness, it could truly become a mass-produced and mass-consumed "Red Pill" that Alex Jones is selling even today. The combined potential users/market of oral T, allopregnanolone, DHT, pregnenolone, etc is huge and this is more than enough people to cause major changes in the corrupt system if they truly wake up.
 

Yucca

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Make your own : 5mg DHT / 20mg test base / 80mg preg. Don’t know for allopreg…

Works even better in suppository form (from coco oil, all easily home made)
 

Yucca

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Not allop, but a mix with melatonin, preg and test, yes. And very soon some curcumin added. My lab rats seems to appreciate them.
 

golder

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Make your own : 5mg DHT / 20mg test base / 80mg preg. Don’t know for allopreg…

Works even better in suppository form (from coco oil, all easily home made)
How do we make suppositories?
 

Yucca

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Precision scale, wax heater (less than $20 on Amazon), suppository molds (usually on essential oils sites), a pipette to transfer the mix, a small kitchen stirrer.
You can use pure organic coco oil. Keep the molds in the fridge after .
Very easy.
 

golder

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Precision scale, wax heater (less than $20 on Amazon), suppository molds (usually on essential oils sites), a pipette to transfer the mix, a small kitchen stirrer.
You can use pure organic coco oil. Keep the molds in the fridge after .
Very easy.
Thanks man. Why do you choose suppository over oral?
 

Yucca

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100% absorption, exactly where it’s needed for anti inflammatory effects (melatonin/curcumin) and gut repair.
If you compare vs oral, melatonin is only absorbed at a 2-3% rate, curcumin even much less, and I guess by experience test base is about 30-50% if taken orally (seems it can be quite different between people)

So you get all you need, with your own custom mix, perfectly absorbed, in a convenient once daily intake only.
 

golder

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100% absorption, exactly where it’s needed for anti inflammatory effects (melatonin/curcumin) and gut repair.
If you compare vs oral, melatonin is only absorbed at a 2-3% rate, curcumin even much less, and I guess by experience test base is about 30-50% if taken orally (seems it can be quite different between people)

So you get all you need, with your own custom mix, perfectly absorbed, in a convenient once daily intake only.
I really think you're on to something here. Definitely going to give this a try! Thanks.
 
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