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Post by ktim on Aug 2, 2021 18:32:29 GMT -5
While I have no idea about what RLS is actually doing with their "capsule", I thought it worth mentioning the obvious, capsules are often times filled with a dry powder, and Technosphere is not solely an inhalation technology... That's a route of application that was chosen for reasons that should be obvious by now, at least on this board, and a few reasons were mentioned in this thread, including the RLS pipeline's next steps, being inhalation to avoid digestive issues as well as faster response. If the capsule is filled with a Technosphere-based API, absorption enhancers would likely be needed; however, I find that pathway through the regulatory framework to be very interesting because inhalation is taken off the table for initial approval. Inhalation introduces a host of additional concerns and delays that could be avoided with an initial capsule. Once approved, the pathway from oral to inhalation might become somewhat more streamlined... Again, I am not saying that's what RLS is doing, but RLS and MNKD would be wise to at least consider this option. If proved successful, MNKD could offer additional partnership options to speed approvals along. What would be the motivation to formulate it as technosphere powder in capsule? It seems CBD is a pretty stable molecule as they are selling it in many forms already and doesn't require refrigeration. |
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Post by lakon on Aug 4, 2021 22:39:07 GMT -5
While I have no idea about what RLS is actually doing with their "capsule", I thought it worth mentioning the obvious, capsules are often times filled with a dry powder, and Technosphere is not solely an inhalation technology... That's a route of application that was chosen for reasons that should be obvious by now, at least on this board, and a few reasons were mentioned in this thread, including the RLS pipeline's next steps, being inhalation to avoid digestive issues as well as faster response. If the capsule is filled with a Technosphere-based API, absorption enhancers would likely be needed; however, I find that pathway through the regulatory framework to be very interesting because inhalation is taken off the table for initial approval. Inhalation introduces a host of additional concerns and delays that could be avoided with an initial capsule. Once approved, the pathway from oral to inhalation might become somewhat more streamlined... Again, I am not saying that's what RLS is doing, but RLS and MNKD would be wise to at least consider this option. If proved successful, MNKD could offer additional partnership options to speed approvals along. What would be the motivation to formulate it as technosphere powder in capsule? It seems CBD is a pretty stable molecule as they are selling it in many forms already and doesn't require refrigeration. Good points. IDK, but I could speculate. It might be easier to control dosage as well as the point I made about a path to inhalation. Also, how stable is it? How long does it last? You can deliver it as a paste without refrigeration, but that does not mean it would last as long as a Technosphere powder. The absorption rates would differ depending on how it's formulated. Technosphere combination therapies were investigated, including stabilizers, for non-inhaled applications. There might be cost benefits to a single manufacturing process with different fill stations... |
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Post by buyitonsale on Aug 17, 2021 21:54:31 GMT -5
www.receptorlife.comAUG 17, 2021 | Press Release Receptor Life Sciences Announces Publication of Proof-of-Principle Clinical Pharmacokinetics Study of RLS103 (Inhaled Dry Powder CBD) SEATTLE – Receptor Life Sciences (RLS), a pharmaceutical company developing innovative therapies to address central nervous system disorders, announced the publication of a manuscript in the Journal of Pharmaceutical Sciences. The paper reports cannabidiol (CBD) pharmacokinetics (PK) in healthy volunteers following inhalation of RLS103, an investigational inhaled dry powder CBD. RLS103 is being developed for the treatment of performance anxiety in patients with social anxiety disorder (SAD), and acute panic in patients with panic disorder. This PK study demonstrated that RLS103 facilitates immediate CBD delivery to the bloodstream with peak concentrations that are 71-fold greater than oral CBD on a dose-adjusted basis at approximately 3.8 minutes. The overall systemic exposure, adjusted for dose, was 9-fold greater than that following oral administration because inhalation delivery bypasses hepatic first-pass metabolism. RLS103 delivered CBD with an efficiency 7-fold greater than a vaporizer. "Based on the PK profile, RLS103 has the potential to be the first-in-class immediate-acting CBD product for time-of-need indications like performance anxiety and acute panic," said Andrea Leone-Bay, PhD, Founder and Chief Scientific Officer of Receptor Life Sciences. "Currently, there are no FDA approved treatment options available for these patients." RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation. The Journal of Pharmaceutical Sciences is a peer-reviewed scientific journal focused on pharmacology and related biotechnology research. It has been a premier journal in the field for over 100 years. Receptor's manuscript can be viewed at ",Improved Bioavailability with Dry Powder Cannabidiol Inhalation: A Phase 1 Clinical Study", Orrin Devinsky, MD; Kelly Kraft, PhD; Lorraine Rusch, PhD; Melanie Fein, MD; Andrea Leone-Bay, PhD" Panic disorder affects about 5.4 million adults in the United States, according to the National Institute of Mental Health. Social Anxiety Disorder affects about 15 million adults in the U.S. and is the second-most commonly diagnosed anxiety disorder (https://adaa.org/understanding-anxiety/social-anxiety-disorder).
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Post by goyocafe on Aug 18, 2021 5:23:11 GMT -5
www.receptorlife.comAUG 17, 2021 | Press Release Receptor Life Sciences Announces Publication of Proof-of-Principle Clinical Pharmacokinetics Study of RLS103 (Inhaled Dry Powder CBD) SEATTLE – Receptor Life Sciences (RLS), a pharmaceutical company developing innovative therapies to address central nervous system disorders, announced the publication of a manuscript in the Journal of Pharmaceutical Sciences. The paper reports cannabidiol (CBD) pharmacokinetics (PK) in healthy volunteers following inhalation of RLS103, an investigational inhaled dry powder CBD. RLS103 is being developed for the treatment of performance anxiety in patients with social anxiety disorder (SAD), and acute panic in patients with panic disorder. This PK study demonstrated that RLS103 facilitates immediate CBD delivery to the bloodstream with peak concentrations that are 71-fold greater than oral CBD on a dose-adjusted basis at approximately 3.8 minutes. The overall systemic exposure, adjusted for dose, was 9-fold greater than that following oral administration because inhalation delivery bypasses hepatic first-pass metabolism. RLS103 delivered CBD with an efficiency 7-fold greater than a vaporizer. "Based on the PK profile, RLS103 has the potential to be the first-in-class immediate-acting CBD product for time-of-need indications like performance anxiety and acute panic," said Andrea Leone-Bay, PhD, Founder and Chief Scientific Officer of Receptor Life Sciences. "Currently, there are no FDA approved treatment options available for these patients." RLS103 is a drug-device combination product based on the Technosphere® dry powder inhalation system licensed from MannKind Corporation. The Journal of Pharmaceutical Sciences is a peer-reviewed scientific journal focused on pharmacology and related biotechnology research. It has been a premier journal in the field for over 100 years. Receptor's manuscript can be viewed at ",Improved Bioavailability with Dry Powder Cannabidiol Inhalation: A Phase 1 Clinical Study", Orrin Devinsky, MD; Kelly Kraft, PhD; Lorraine Rusch, PhD; Melanie Fein, MD; Andrea Leone-Bay, PhD" Panic disorder affects about 5.4 million adults in the United States, according to the National Institute of Mental Health. Social Anxiety Disorder affects about 15 million adults in the U.S. and is the second-most commonly diagnosed anxiety disorder (https://adaa.org/understanding-anxiety/social-anxiety-disorder). why so little fanfare about such a significant study? Why fly this one under the radar when we hear all about a race car and other events with questionable merit? |
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Post by uvula on Aug 18, 2021 9:03:38 GMT -5
Mnkd probably has an agreement that RLS gets to announce RLS stuff before MNKD can.
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Post by cretin11 on Aug 18, 2021 9:27:08 GMT -5
Does anyone know what dosages are being contemplated with this product?
Typical dosage amounts for currently available oral CBD products (whether spray, tincture, gummy, capsule, flower, etc.) range from 10 mg to 100 mg. The RLS release above mentions higher concentrations, so I’m wondering how many mgs.
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Post by peppy on Aug 18, 2021 9:32:19 GMT -5
Does anyone know what dosages are being contemplated with this product? Typical dosage amounts for currently available oral CBD products (whether spray, tincture, gummy, capsule, flower, etc.) range from 10 mg to 100 mg. The RLS release above mentions higher concentrations, so I’m wondering how many mgs. wasn't it, higher blood level concentrations of CBD with less product? itellthefuture777 added, itell posted this from the study. Following a single dose of Epidiolex or DPI CBD (n=10 PK evaluable participants each), the maximum CBD concentration for the inhaled powder was 71-fold higher than that of Epidiolex while administering 24-fold less CBD. The mean time to reach maximum concentration was 3.8 minutes for the DPI CBD formulation compared with 122 minutes for Epidiolex. Both Epidiolex and DPI CBD were generally safe and well-tolerated The study, published in Journal of Pharmaceutical Sciences www.sciencedirect.com/science/article/pii/S0022354921004135(I just checked in to see what condition my condition is in.) |
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Post by cretin11 on Aug 18, 2021 10:25:37 GMT -5
Correct, higher blood level concentrations with less product.
CBD users know how much dosage they like based on mgs. What I’m wondering is the dosage level needed to deal with a panic attack (or any other use contemplated by the RLS product), to put that in perspective. It is made trickier to compare by the apparent increase in efficiency of delivery by the TS platform. But that’s a great “problem” to have.
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Post by peppy on Aug 18, 2021 10:29:23 GMT -5
Correct, higher blood level concentrations with less product. CBD users know how much dosage they like based on mgs. What I’m wondering is the dosage level needed to deal with a panic attack (or any other use contemplated by the RLS product), to put that in perspective. It is made trickier to compare by the apparent increase in efficiency of delivery by the TS platform. But that’s a great “problem” to have. isn't the comparator, oral? (what condition my condition is in) |
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Post by cretin11 on Aug 18, 2021 14:26:44 GMT -5
Not sure I understand the question, but yes oral is the comparison I think, though oral ingestion of CBD can come in various forms including sprays, tinctures, gummies, capsules, etc. All of those are measured in milligrams so I’m wondering if that will be the same for the RLS product and if so, how many mgs.
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Post by peppy on Aug 18, 2021 14:28:34 GMT -5
Not sure I understand the question, but yes oral is the comparison I think, though oral ingestion of CBD can come in various forms including sprays, tinctures, gummies, capsules, etc. All of those are measured in milligrams so I’m wondering if that will be the same for the RLS product and if so, how many mgs. Think about it cretin, oral vs IV. I just checked in to see..... want condition..... because when I go to the hospital, they start an oral..... (?) |
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Post by cretin11 on Aug 18, 2021 14:43:13 GMT -5
Not sure I understand the question, but yes oral is the comparison I think, though oral ingestion of CBD can come in various forms including sprays, tinctures, gummies, capsules, etc. All of those are measured in milligrams so I’m wondering if that will be the same for the RLS product and if so, how many mgs. Think about it cretin, oral vs IV. I just checked in to see..... want condition..... because when I go to the hospital, they start an oral..... (?) Is there a peppy-to-English translator out there? 😆 peppy: what point are you trying to make about IV? This is about oral application, not IV, or smoking, or other applications. And regardless, all those can be measured in milligrams (getting back to my original question). |
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Post by peppy on Aug 18, 2021 15:11:09 GMT -5
Think about it cretin, oral vs IV. I just checked in to see..... want condition..... because when I go to the hospital, they start an oral..... (?) Is there a peppy-to-English translator out there? 😆 peppy: what point are you trying to make about IV? This is about oral application, not IV, or smoking, or other applications. And regardless, all those can be measured in milligrams (getting back to my original question). I want you to notice the respect. Cretin, look at the delivery system of the dreamboat. Right into the circulation. An IV is directly into the circulation. This is the end of this conservation with me now.  |
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Post by cretin11 on Aug 18, 2021 15:37:22 GMT -5
peppy, I posed a fairly simple question six hours ago. You responded several times without answering the question. That’s fine, it’s entertaining in a way, and perhaps someone else can answer my simple question (or I could do the research myself, but I’m pretty lazy about that stuff).
Some of your responses contained nonsensical language, hence my “peppy-to-English translator” joke. It was meant in jest, my apologies if it came across as disrespectful. I’m used to people making fun of me (after all, I’m a cretin) and it doesn’t bother me a bit, but that doesn’t give me license to make fun of you.
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Post by casualinvestor on Aug 19, 2021 9:37:10 GMT -5
Being a nerd, I found the manufacture process interesting. But more importantly, the PK graph for CBD was faster than what I remember for insulin. Oral has essentially no effect on blood CBD concentration for 15-20 minutes. Inhaled peaked at ~3m at 15000 as they said (the graph is hard to get exact times from), but was down to ~2500 15-20 minutes after dosing.
MNKD is focusing on lung-delivery and therapeutics for lung diseases. That's ok, they have a full plate right now. But speed-of-onset delivery is going to become another selling point some time down the line (first panic attacks, later migraines maybe, etc)
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