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Post by mnholdem on Aug 10, 2018 11:10:07 GMT -5
Application Date: January 13, 2018 Publication Date: August 9, 2018
Application Number: 15885416
(US20180221280) HEAT-STABLE DRY POWDER PHARMACEUTICAL COMPOSITIONS AND METHODS
Excerpt:
SUMMARY
The present disclosure provides dry powder compositions for inhalation which are stable at room temperature or higher temperatures for prolonged periods of time without substantially losing their biological activity. In one embodiment, a pharmaceutical formulation is provided comprising a dry powder for inhalation comprising a biologic molecule, wherein the biologic molecule comprises a peptide or a protein for systemic delivery using a dry powder inhalation system comprising an inhaler that can be used with a unit dose cartridge or capsule for multiple use, a single use inhaler with an integrally built-in container for single use, or a multi-dose inhaler provided with a plurality of doses integrally configured with the inhaler.
DETAILED DESCRIPTION
Drug delivery to the lungs offers many advantages. It is difficult to deliver drugs into the lungs due to problems in transporting the drugs past natural physical barriers in a uniform volume and weight of the drug and the drug physical and chemical characteristics. Disclosed herein are heat-stable formulations comprising, a buffer, including, citrate, and a monovalent, or divalent cation, and one or more pharmaceutically acceptable carriers and/or excipients. Embodiments disclosed herein show that the dry powder formulations are stable at high heat and humidity and thus they facilitate and overcome the storage and refrigeration challenges posed by prior art formulations. A method of making the dry powder composition for extended storage at temperatures greater than 20° C. and humid environments is also provided.
Source: patentscope.wipo.int/search/en/detail.jsf?docId=US224374923&recNum=1&maxRec=1114&office=&prevFilter=&sortOption=Pub+Date+Desc&queryString=FP%3A%28mannkind%29&tab=PCTDescription
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Post by seanismorris on Aug 10, 2018 11:17:51 GMT -5
Are Afrezza expands globally this could be useful.
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Post by boca1girl on Aug 10, 2018 12:02:25 GMT -5
Hurray !!!! I’ve been waiting for this great news. Hopefully a label change will soon follow.
This will be a great cost saving and convenience for every link in the manufacturing / distribution system and the users of all TI products.
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Post by mnholdem on Aug 10, 2018 12:12:46 GMT -5
Unfortunately, I don't think this will affect the Afrezza label. It's a different formulation, so MannKind would have to do clinical trials all over again to prove its safety and efficacy. It does bode well for future drugs though.
Having said that, MannKind can also initiate trials of their existing Afrezza formulation to prove that room-storage temperature doesn't affect Technosphere Insulin, but the clinical trials would be lengthy and expensive. |
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Post by Clement on Aug 10, 2018 12:16:12 GMT -5
Unfortunately, I don't think this will affect the Afrezza label. It's a different formulation, so MannKind would have to do clinical trials all over again to prove its safety and efficacy. It does bode well for future drugs though.
Having said that, MannKind can also initiate trials of their existing Afrezza formulation to prove that room-storage temperature doesn't affect Technosphere Insulin, but the clinical trials would be lengthy and expensive. Could Cipla do testing or trials in India for India at a reasonable price? Amphastar ... in China? |
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Post by pantaloons on Aug 10, 2018 12:17:22 GMT -5
Hurray !!!! I’ve been waiting for this great news. Hopefully a label change will soon follow. This will be a great cost saving and convenience for every link in the manufacturing / distribution system and the users of all TI products. This is positive news in that MNKD has provided credence to this important feature of TI. It is to my understanding, however, that until a controlled clinical trial is conducted, an FDA label change will not happen soon, unfortunately. Nonetheless, I think this feature will eventually add nicely to the concept that Afrezza can boost compliance amongst PWDs, i.e., it is convenient and practical to administer to carry on person everywhere. |
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Post by boca1girl on Aug 10, 2018 12:23:54 GMT -5
Unfortunately, I don't think this will affect the Afrezza label. It's a different formulation, so MannKind would have to do clinical trials all over again to prove its safety and efficacy. It does bode well for future drugs though.
Having said that, MannKind can also initiate trials of their existing Afrezza formulation to prove that room-storage temperature doesn't affect Technosphere Insulin, but the clinical trials would be lengthy and expensive. MN, you certainly know how to burst a girl’s (my) bubble. 😢 How do you know that it wouldn’t apply to Afrezza? Is it because of the particle size? |
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Post by tinkusr8215 on Aug 10, 2018 13:02:53 GMT -5
Unfortunately, I don't think this will affect the Afrezza label. It's a different formulation, so MannKind would have to do clinical trials all over again to prove its safety and efficacy. It does bode well for future drugs though.
Having said that, MannKind can also initiate trials of their existing Afrezza formulation to prove that room-storage temperature doesn't affect Technosphere Insulin, but the clinical trials would be lengthy and expensive. MN, you certainly know how to burst a girl’s (my) bubble. 😢 How do you know that it wouldn’t apply to Afrezza? Is it because of the particle size? I guess its Afrezza thats approved by FDA and administered and not technosphere. Any label change requires studies and results presented to FDA and approved. |
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Post by peppy on Aug 10, 2018 14:11:16 GMT -5
Unfortunately, I don't think this will affect the Afrezza label. It's a different formulation, so MannKind would have to do clinical trials all over again to prove its safety and efficacy. It does bode well for future drugs though.
Having said that, MannKind can also initiate trials of their existing Afrezza formulation to prove that room-storage temperature doesn't affect Technosphere Insulin, but the clinical trials would be lengthy and expensive. I know, I know, let's put Afrezza in a green house for a few months and try it. That particular video is not posted on youtube by Matt B. www.youtube.com/results?search_query=matt+bendall+afrezza |
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Post by mnholdem on Aug 10, 2018 14:23:00 GMT -5
Unfortunately, I don't think this will affect the Afrezza label. It's a different formulation, so MannKind would have to do clinical trials all over again to prove its safety and efficacy. It does bode well for future drugs though.
Having said that, MannKind can also initiate trials of their existing Afrezza formulation to prove that room-storage temperature doesn't affect Technosphere Insulin, but the clinical trials would be lengthy and expensive. MN, you certainly know how to burst a girl’s (my) bubble. 😢 How do you know that it wouldn’t apply to Afrezza? Is it because of the particle size? Sorry to be a heartbreaker. The chemicals used to make the particles is different. |
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Post by peppy on Aug 10, 2018 14:25:37 GMT -5
MN, you certainly know how to burst a girl’s (my) bubble. 😢 How do you know that it wouldn’t apply to Afrezza? Is it because of the particle size? Sorry to be a heartbreaker. The chemicals used to make the particles is different. RLS different? The devil Made me ask. www.screencast.com/t/tRMaq7iL |
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Post by harryx1 on Aug 10, 2018 14:29:43 GMT -5
Unfortunately, I don't think this will affect the Afrezza label. It's a different formulation, so MannKind would have to do clinical trials all over again to prove its safety and efficacy. It does bode well for future drugs though.
Having said that, MannKind can also initiate trials of their existing Afrezza formulation to prove that room-storage temperature doesn't affect Technosphere Insulin, but the clinical trials would be lengthy and expensive. I know, I know, let's put Afrezza in a green house for a few months and try it. That particular video is not posted on youtube by Matt B. www.youtube.com/results?search_query=matt+bendall+afrezza |
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Post by hammer on Aug 11, 2018 15:43:23 GMT -5
So Mannkind has developed a different formulation which can provide room temperature storage for a prolonged period of time.
My question is can the powder be reconstituted for injection? If so this IP is beneficial for both Mannkind and BP. Sold for reconstitution purposes only could attract a few suitors and their money.
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Post by peppy on Aug 11, 2018 15:54:19 GMT -5
"Disclosed herein are heat-stable formulations comprising, a buffer, including, citrate, and a monovalent, or divalent cation, and one or more pharmaceutically acceptable carriers and/or excipients."
when I see buffer, I think, "oral" ; or a formulation that needs a buffer. I barely understand PKA.
buff me.
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