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Post by kc on Jul 11, 2016 11:09:42 GMT -5
Can anybody peel back the onion on this US Patent office filing on the Monash Oxytocin. I can't seem to find a link to their inhaler on it. (nasal inhalation vs Oral inhalaton?) I do not have the time to read the entire document.
www.google.com/patents/US20140294969
Publication number US20140294969 A1 Publication type Application Application number US 14/236,465 PCT number PCT/AU2011/001430 Publication date Oct 2, 2014 Filing date Nov 7, 2011 Priority date Aug 1, 2011 Also published as CA2879317A1, 4 More » Inventors Michelle McIntosh, David Morton, Tomas Sou, Livesey Olerile, Richard Prankerd Original Assignee Monash University Export Citation BiBTeX, EndNote, RefMan Patent Citations (1), Non-Patent Citations (7), Classifications (12), Legal Events (1)
External Links: USPTO, USPTO Assignment, Espacenet
Method and formulation for inhalation US 20140294969 A1
Abstract
This invention relates to drug delivery and in particular to the delivery of biologically active agents in the form of dry powders for inhalation. The invention also relates to methods for preparing such dry powder formulations and methods for their use.
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Post by Deleted on Jul 11, 2016 11:14:02 GMT -5
Can anybody peel back the onion on this US Patent office filing on the Monash Oxytocin. I can't seem to find a link to their inhaler on it. (nasal inhalation vs Oral inhalaton?) I do not have the time to read the entire document.
www.google.com/patents/US20140294969
Publication number US20140294969 A1 Publication type Application Application number US 14/236,465 PCT number PCT/AU2011/001430 Publication date Oct 2, 2014 Filing date Nov 7, 2011 Priority date Aug 1, 2011 Also published as CA2879317A1, 4 More » Inventors Michelle McIntosh, David Morton, Tomas Sou, Livesey Olerile, Richard Prankerd Original Assignee Monash University Export Citation BiBTeX, EndNote, RefMan Patent Citations (1), Non-Patent Citations (7), Classifications (12), Legal Events (1)
External Links: USPTO, USPTO Assignment, Espacenet
Method and formulation for inhalation US 20140294969 A1
Abstract
This invention relates to drug delivery and in particular to the delivery of biologically active agents in the form of dry powders for inhalation. The invention also relates to methods for preparing such dry powder formulations and methods for their use.
this is based on exubera technology.. The dry powder formulation comprised a spray dried composition, as described in example 1. This powder contained 13 units of oxytocin per mg by mass, co-spray dried with equal proportions by mass of mannitol, glycine and leucine.
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Post by mnholdem on Jul 11, 2016 11:31:39 GMT -5
Excerpt from patent link provided (above):
[0043]
Dry powder inhalers may be passive or active. Passive inhalers are those whereby the powder is aerosolised using the air flow drawn through the device by the patients inwards breath, and active devices are those whereby the powder is aerosolised by a separate source of energy, which may for example be a source of compressed gas such as the Nektar Exubera device or Vectura Aspirar device, or a form of mechanical energy such as vibration (such as the Microdose device) or impact.
[0044] The dry powder inhaler devices suitable for use in the present invention include “single dose” devices, for example the Rotahaler (trade mark), the Spinhaler (trade mark) and the Diskhaler (trade mark) in which individual doses of the powder composition are introduced into the device in, for example, single dose capsules or blisters. Devices may be presented as pre-metered for example with powder in a blister strip (as with the GSK Diskus device) where the pre-metered format comprises multiple doses) or where the patient inserts a pre-metered external dose form, such as a capsule containing the drug (for example the Boehringer Ingelheim Handihaler, or the Miat Monodose).
[0045] Alternatively, the device may be a reservoir device, where the powder dose is metered within the device from a powder reservoir during patient handling (for example the Astra Turbuhaler). Any of these inhaler device types may be used.
[0046] The device may preferably be a single use device, or one which is designed for use with a small number of doses, and may be disposable. For example, the Twincer device, the Direct Haler device, the TwinCaps device or the Puff-haler. An advantage of these devices is their simplicity, small number of components and low cost. Preferably a device with fewer than 10 independent components is preferred. More preferably, 5 or fewer, most preferably 3 or fewer.
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It would appear that the patent is on the formulation only and does not include any specific delivery device.
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Post by peppy on Jul 11, 2016 11:37:35 GMT -5
Excerpt from patent link provided (above):
[0043]
Dry powder inhalers may be passive or active. Passive inhalers are those whereby the powder is aerosolised using the air flow drawn through the device by the patients inwards breath, and active devices are those whereby the powder is aerosolised by a separate source of energy, which may for example be a source of compressed gas such as the Nektar Exubera device or Vectura Aspirar device, or a form of mechanical energy such as vibration (such as the Microdose device) or impact.
[0044] The dry powder inhaler devices suitable for use in the present invention include “single dose” devices, for example the Rotahaler (trade mark), the Spinhaler (trade mark) and the Diskhaler (trade mark) in which individual doses of the powder composition are introduced into the device in, for example, single dose capsules or blisters. Devices may be presented as pre-metered for example with powder in a blister strip (as with the GSK Diskus device) where the pre-metered format comprises multiple doses) or where the patient inserts a pre-metered external dose form, such as a capsule containing the drug (for example the Boehringer Ingelheim Handihaler, or the Miat Monodose).
[0045] Alternatively, the device may be a reservoir device, where the powder dose is metered within the device from a powder reservoir during patient handling (for example the Astra Turbuhaler). Any of these inhaler device types may be used.
[0046] The device may preferably be a single use device, or one which is designed for use with a small number of doses, and may be disposable. For example, the Twincer device, the Direct Haler device, the TwinCaps device or the Puff-haler. An advantage of these devices is their simplicity, small number of components and low cost. Preferably a device with fewer than 10 independent components is preferred. More preferably, 5 or fewer, most preferably 3 or fewer.
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It would appear that the patent is on the formulation only and does not include any specific delivery device. mn, didn't a delivery device patent to GSK pass through here 6 months ago? remember it?
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Post by ilovekauai on Jul 11, 2016 11:40:29 GMT -5
Well, it seems pretty obvious that the device he is holding is the Dreamboat Technosphere. However based on listening to the u tube that was provided in another post, I'm not holding my breath that this is coming to market anytime soon. I mean the guy was literally asking for help. This doesn't add up to much in my book but hey, what the hell do I know. Aloha.
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Post by brentie on Jul 11, 2016 11:46:16 GMT -5
Thanks KC, that worked. If anyone else is interested here it is. It's about a year old. www.amge.ch/2015/06/22/accoucher-sans-danger/(I thought that this would show the english version but apparently you'll have to use Google translate on the page I provided a link to.)
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Post by peppy on Jul 11, 2016 11:54:09 GMT -5
Thanks KC, that worked. If anyone else is interested here it is. It's about a year old. www.amge.ch/2015/06/22/accoucher-sans-danger/(I thought that this would show the english version but apparently you'll have to use Google translate on the page I provided a link to.) Refurbished in powder form, a drug could save the lives of many mothers in developing countries
"Every year, 140,000 women die because of uncontrolled bleeding after childbirth. Most - 99% - in developing countries, said Robin Offord, Honorary Professor at the Faculty of Medicine of the University of Geneva (UNIGE) and executive director of the Mintaka Foundation. Some 1.6 million mothers survive this disease, but are severely anemic, with serious consequences for their infants and their families. "
Yet there is a simple and effective drug against postpartum hemorrhage: oxytocin, a hormone naturally secreted during childbirth, which has the ability to contract the uterus and thus enable stopping bleeding. "In Switzerland, we are injecting this molecule women systematically preventively just after the baby is born, says Professor Begoña Martinez de Tejada, Associate Assistant doctor, head of the obstetrics unit at high risk at the University Hospitals of Geneva ( HUG). This minimizes the bleeding. If we do not administer this drug this dangerous complication affects 5% of women giving birth, making it the leading cause of maternal death during pregnancy in the world. "
Less than a dollar a dose Problem: oxytocin keeps evil. "This compound supports neither heat nor humidity. It degrades very quickly in these conditions, reports Robin Offord. To use it, we must have fridges in hospitals and chain of cold suitable for transport in remote areas. But very often tropical countries do not have such infrastructures. "
To remedy the problem, Robin Offord had the idea to change the form of the drug. "At a conference on a different subject, I have heard of insulin inhalation powder, a product developed by the company MannKind Corporation to replace injections in the treatment of diabetes type 1 and 2, says the professor. I immediately said, "This is the solution for postpartum hemorrhage." Oxytocin is indeed available in liquid form, but it would be more stable powder. So I contacted the company MannKind to whether it would be possible to develop such a product. They said they did not have the means but, perhaps, some of their employees agree to work on the topic as volunteers. This is how the adventure began. "
It will take three years for scientists to reach a result. "Initially, our oxytocin powder was less stable than the liquid version smiles Oliver Hartley, master teaching and research at the Faculty of Medicine of the University of Geneva and Scientific Director of the Mintaka Foundation. But now we are there. Our drug remains 98% pure, after eight months in harsh conditions, up to 40 ° C and 75% relative humidity. "
To administer it to patients, researchers might use a small plastic inhaler. "The simplicity of this system and its low cost - less than a dollar each - allow mothers to use anywhere in the world, welcomes Robin Offord. Even in the absence of medical personnel, anyone can use an inhaler. While injections require knowledge. "For Begoña Martinez de Tejada," This innovation has the potential to save many lives. In Switzerland, we do not need this product, but for developing countries, this is a huge opportunity. "
Clinical trials to lead The inhaler of oxytocin powder imagined by Mintaka received last November, the Innovation Award 2014 HUG. However, the hard part is done. "The company has tested our MannKind inhaler on a machine that simulates lung function. It seems that the molecule is found both in blood at concentrations comparable to those observed when the drug is injected, continues Offord. But to be sure that it works and that there are no adverse side effects, we must now conduct clinical trials of Phase I. "
Research that has a cost: between 200 000 and 400 000 dollars, not counting the production of the drug. "We will start seeking financing, smiled Robin Offord. But this is not the first time. I am sure we will find "In this process, the team received significant support. HUG, who are very interested in participating in research.
"We are ready to do clinical trials of phase I, reports Professor Jules Desmeules, head of the Clinical Investigation Unit of the University Hospitals of Geneva. We have already written a research protocol. It must now be approved by the Ethics Commission and then by Swissmedic, the body that controls drugs in Switzerland. If all goes well, Phase I could be completed within a year. In addition, for phases II and III will require that a pharmaceutical company takes over. "
But the powder inhaled oxytocin happens or not one day on the market, the Mintaka Foundation opened a new promising way: "Many therapeutic molecules exist only in liquid form, which makes them unstable to heat and moisture. Many drugs could therefore benefit from our technology and move in solid form, to be better adapted to South climatic conditions. " Bertrand Beauty
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Post by kc on Jul 11, 2016 12:46:38 GMT -5
Well, it seems pretty obvious that the device he is holding is the Dreamboat Technosphere. However based on listening to the u tube that was provided in another post, I'm not holding my breath that this is coming to market anytime soon. I mean the guy was literally asking for help. This doesn't add up to much in my book but hey, what the hell do I know. Aloha. Denise,
Monash is competing against Mintaka with the same idea concept on Inhaled oxytocin. Monash appears to be funded by GSK. Both Mintaka and Monash have been working with USAID/ Gates Foundation and other world health groups on this project. Who brings it to market first will be who has the funding to get it done.
Could both groups partner together? Perhaps or perhaps not.
Mintaka was in Round 5. but not in Round 6.
Monash invited to Round 6. July 2016 but was not in Round 5.
Who Knows?
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