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Post by mnholdem on Jul 6, 2019 12:58:40 GMT -5
Preparation, characterization, and pharmacodynamics of insulin-loaded fumaryl diketopiperazine microparticle dry powder To link to this article: doi.org/10.1080/10717544.2019.1631408Excerpt: “Conclusion: To sum up, the aim was to develop a non-injection system for insulin, INS@FDKP-MPs powder inhalation with high dose, low toxicity, and good lung deposition inhalation could rapidly decrease the blood glucose level without immune stimulation, which shows remarkably potential on diabetes treatment by pulmonary delivery route.” |
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Post by letitride on Jul 6, 2019 13:20:33 GMT -5
Looks like the Chinese are working on an Afrezza knock off, and people thought Afrezza had issues.
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Post by goyocafe on Jul 6, 2019 13:54:45 GMT -5
Preparation, characterization, and pharmacodynamics of insulin-loaded fumaryl diketopiperazine microparticle dry powder To link to this article: doi.org/10.1080/10717544.2019.1631408Excerpt: “Conclusion: To sum up, the aim was to develop a non-injection system for insulin, INS@FDKP-MPs powder inhalation with high dose, low toxicity, and good lung deposition inhalation could rapidly decrease the blood glucose level without immune stimulation, which shows remarkably potential on diabetes treatment by pulmonary delivery route.” Conclusion: WTF? |
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Post by mnholdem on Jul 6, 2019 21:08:01 GMT -5
Nothing wrong with educating China before Afrezza gets there.
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Post by goyocafe on Jul 6, 2019 22:43:48 GMT -5
Nothing wrong with educating China before Afrezza gets there. Agreed. So long as they don't intend to re-invent their own version. |
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Post by rtmd on Jul 7, 2019 9:44:50 GMT -5
Nothing wrong with educating China before Afrezza gets there. Agreed. So long as they don't intend to re-invent their own version. Indeed, that was the impression I got from the article. |
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Post by chc on Jul 7, 2019 10:31:35 GMT -5
This could be good news to come at some future date. The conclusion seems to confirm the Chinese like the Technosphere Inhaled Insulin and delivery to the lungs particle. Question, are they looking to manufacture their own product? I would like to see a deal with Mannkind Corporation for Afrezza distribution in China.
Conclusion
In this study, we have demonstrated the use of FDKP, approved by the FDA for insulin delivery. FDKP as a carrier material prepared insulin lung powder inhalation not only possess good reproducibility but also has good atomization performance and effective pulmonary deposition, which is an effective therapy for the diabetes treatment.
Results in vivo clearly suggested that insulin dry powder inhalations for targeted pulmonary delivery offer advantages in providing direct access to disease sites and minimizing the occurrence of side effects compared to subcutaneous injection insulin. INS@FDKP-MPs powder inhalation could rapidly decrease the blood sugar level without immune stimulation, which shows remarkably potential for diabetes treatment by pulmonary delivery route.
Irritation test results showed that 24 h after administration, some symptoms like the trachea, bronchus, lung congestion were not observed. The alveoli show uniform size and intact structure with the thicknesses of alveolar cavity walls also keeps normal in all research groups, suggesting the safety of pulmonary delivery of INS@FDKP-MPs was satisfied.
In summary, this research demonstrated an innovative approach of formulating existing therapeutics for targeted pulmonary delivery to better manage diabetes. It also shed light on exciting opportunities to utilize existing technologies to overcome the limitations of conventional delivery routes, potentially improving both bioavailability and therapeutic efficacy.
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Post by longliner on Jul 7, 2019 11:45:02 GMT -5
It would be nice if Amphastar was driving this.
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Post by mnkdfann on Jul 7, 2019 11:52:54 GMT -5
Says the paper:
"Although the inhaled insulin powder Afrezza®, which has been marketed, can significantly reduce the incidence of hypoglycemia and relieve the pain of patients, the sales volume and the market feedback of Afrezza® is unsatisfactory as well. The reason for the poor sales of Afrezza® may be that people are still skeptical about the safety of insulin DPIs, and the price of the inhaler and its associated inhalation device is higher than that of insulin injection (Fantasia, 2015 Fantasia HC. (2015). Inhaled insulin – a new delivery for an old drug. Nurs Womens Health 19:67–70.). Compared with Afrezza®, this paper aims to optimize the preparation process of INS@FDKP-MPs by adopting a simpler and more convenient synthesis method to reduce the production cost, and by evaluating the properties of INS@FDKP-MPs, it is intended to construct an inhalable insulin preparation that is qualified in particle size, drug loading, hypoglycemic effect, and safety."
China don't want Afrezza. They say they are working on something better.
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Post by goyocafe on Jul 7, 2019 12:04:21 GMT -5
Says the paper: "Although the inhaled insulin powder Afrezza®, which has been marketed, can significantly reduce the incidence of hypoglycemia and relieve the pain of patients, the sales volume and the market feedback of Afrezza® is unsatisfactory as well. The reason for the poor sales of Afrezza® may be that people are still skeptical about the safety of insulin DPIs, and the price of the inhaler and its associated inhalation device is higher than that of insulin injection (Fantasia, 2015 Fantasia HC. (2015). Inhaled insulin – a new delivery for an old drug. Nurs Womens Health 19:67–70.). Compared with Afrezza®, this paper aims to optimize the preparation process of INS@FDKP-MPs by adopting a simpler and more convenient synthesis method to reduce the production cost, and by evaluating the properties of INS@FDKP-MPs, it is intended to construct an inhalable insulin preparation that is qualified in particle size, drug loading, hypoglycemic effect, and safety." China don't want Afrezza. They say they are working on something better. Thumbs up for finding the language that concerns me, not because I like the notion.  Unless Mannkind is assisting behind the scenes and realizes changing the method for preparation in the U.S. would be daunting and plan on moving forward in China with a different process. I can only imagine the IP mote that is around Afrezza, but I also don't know that any of it would ever slow China down. |
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Post by mnkdfann on Jul 7, 2019 14:39:38 GMT -5
Says the paper: "Although the inhaled insulin powder Afrezza®, which has been marketed, can significantly reduce the incidence of hypoglycemia and relieve the pain of patients, the sales volume and the market feedback of Afrezza® is unsatisfactory as well. The reason for the poor sales of Afrezza® may be that people are still skeptical about the safety of insulin DPIs, and the price of the inhaler and its associated inhalation device is higher than that of insulin injection (Fantasia, 2015 Fantasia HC. (2015). Inhaled insulin – a new delivery for an old drug. Nurs Womens Health 19:67–70.). Compared with Afrezza®, this paper aims to optimize the preparation process of INS@FDKP-MPs by adopting a simpler and more convenient synthesis method to reduce the production cost, and by evaluating the properties of INS@FDKP-MPs, it is intended to construct an inhalable insulin preparation that is qualified in particle size, drug loading, hypoglycemic effect, and safety." China don't want Afrezza. They say they are working on something better. Thumbs up for finding the language that concerns me, not because I like the notion. Unless Mannkind is assisting behind the scenes and realizes changing the method for preparation in the U.S. would be daunting and plan on moving forward in China with a different process. I can only imagine the IP mote that is around Afrezza, but I also don't know that any of it would ever slow China down. Anything is possible, but Occam's razor suggests it is just what the article says it is. China looking for a new improved better replacement for Afrezza. (And see funding note below.) If it was Mannkind behind the scenes, why would the paper be bad-mouthing Afrezza by commenting on its relative high cost, poor sales, people worried about its safety, etc? So I'm surprised there are 'longs' over at StockTwits giving this paper a thumbs up, but nothing surprises me much any more. BTW, in case anyone missed details about the paper's funding: "This work was supported by the Ministry of Science and Technology of China (No. 2017ZX09101001-005-003), the National Natural Science Foundation of China (No. 81501579) and (No. 81673364), the Natural Science Foundation of Jiangsu Province (No. BK20150702), the Science and Technology Development Fund of Nanjing Medical University (2016NJMU105), the Priority Academic Program Development of Jiangsu Higher Education Institutions and the Postgraduate Research & Practice Innovation Program of Jiangsu Province (KYCX17_0674)." |
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Post by goyocafe on Jul 7, 2019 14:44:36 GMT -5
Thumbs up for finding the language that concerns me, not because I like the notion. Unless Mannkind is assisting behind the scenes and realizes changing the method for preparation in the U.S. would be daunting and plan on moving forward in China with a different process. I can only imagine the IP mote that is around Afrezza, but I also don't know that any of it would ever slow China down. Anything is possible, but Occam's razor suggests it is just what the article says it is. China looking for a new improved better replacement for Afrezza. (And see funding note below.) If it was Mannkind behind the scenes, why would the paper be bad-mouthing Afrezza by commenting on its relative high cost, poor sales, people worried about its safety, etc? So I'm surprised there are 'longs' over at StockTwits giving this paper a thumbs up, but nothing surprises me much any more. BTW, in case anyone missed details about the paper's funding: "This work was supported by the Ministry of Science and Technology of China (No. 2017ZX09101001-005-003), the National Natural Science Foundation of China (No. 81501579) and (No. 81673364), the Natural Science Foundation of Jiangsu Province (No. BK20150702), the Science and Technology Development Fund of Nanjing Medical University (2016NJMU105), the Priority Academic Program Development of Jiangsu Higher Education Institutions and the Postgraduate Research & Practice Innovation Program of Jiangsu Province (KYCX17_0674)." I'm sure MC is aware of this, right?!  |
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Post by letitride on Jul 7, 2019 14:49:17 GMT -5
Im not worried about china making their own version of Afrezza in a matter of a couple of years everyone will be on inhaled insulin only to discover what happens with everything from china, its hugely defective and they will have to switch to the real thing.
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Post by agedhippie on Jul 7, 2019 15:44:54 GMT -5
... Compared with Afrezza®, this paper aims to optimize the preparation process of INS@FDKP-MPs by adopting a simpler and more convenient synthesis method to reduce the production cost, and by evaluating the properties of INS@FDKP-MPs, it is intended to construct an inhalable insulin preparation that is qualified in particle size, drug loading, hypoglycemic effect, and safety." China don't want Afrezza. They say they are working on something better. Thumbs up for finding the language that concerns me, not because I like the notion. Unless Mannkind is assisting behind the scenes and realizes changing the method for preparation in the U.S. would be daunting and plan on moving forward in China with a different process. I can only imagine the IP mote that is around Afrezza, but I also don't know that any of it would ever slow China down. This is the problem with a lot of the patents Mannkind holds - they are around process and not fundamental. They have value in stopping companies from duplicating the process, but not from finding another process to achieve the same results. The prime example of this is probably Humalog and Novolog which both use the same idea, but different processes to achieve that idea. I do think you are correct though and it is not a threat to Afrezza in the US and Europe, but it probably forecloses the Chinese market and likely a lot of Asia as well. Being in a trade war with China isn't going to help with IP enforcement either. The more interesting question is if they will start using FDKP for other drugs. That might actually help because right now FDKP inhaled drugs are a bit of a backwater and China could definitely provide credibility. |
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Post by mnkdfann on Jul 7, 2019 15:52:22 GMT -5
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Unless Mannkind is assisting behind the scenes and realizes changing the method for preparation in the U.S. would be daunting and plan on moving forward in China with a different process. I can only imagine the IP mote that is around Afrezza, but I also don't know that any of it would ever slow China down.
