|
|
Post by oldfishtowner on Jul 12, 2017 8:08:22 GMT -5
I just watched the @afrezzasaved video on converting a 4- or 8-unit cartridge into a 2-unit cartridge. If T1's are able to count carbs and determine how much insulin they sould take, and then measure out their dose and inject themselves, why not assemble their own Afrezza cartridge?
Apparently the Afrezza cartridge consists of two parts - the carrier that holds a small cube-shaped object with an open flanged top that contains the technosphere insulin and the cube iteself that easily snaps into the bottom of the carrier which is then inserted into the inhaler. If afrezzasavedmylife can disassemble Afrezza cartridges to convert larger unit cartridges into smaller ones and reassemble them, then why can't the TI cubes (containing the TI) be sold separately from the carrier that is inserted into the inhaler?
The TI containing cubes can't be more than 1 cm on each side. They could be dispensed in bulk as pills are and the carriers and inhalers dispensed separately. I know about the problem of physicians/pharmacists forgetting to provide the inhaler when it was not included in the box, but that is no excuse for considering a totally different distribution and packaging scheme.
The advantages: The TI "cubes" could be distributed in bulk and would take up much less refrigerated space than refrigerating the entire kit. Fewer carrier portions of the cartridge would be required, saving money and perhaps lowering prescription prices a bit. And prescriptions could be better tailored to the patient's needs without worrying about packaging configurations. That is, TI could be dispensed in any quantities of 4, 8, or 12- unit "cubes" and the patient provided by a sufficient number of "carriers" so a week's worth of doses could be prepared at any given time.
The cube would have to have easily removed seals on the top that are color coded and marked with the dose. The carriers similarly color coded and marked. The video shows that the cubes are easily snapped into the carrier and then correctly position and locked in by sliding the cube to the front of the carrier. Seems simple enough.
I think the Afrezza packaging is still problematic today. Separating the TI from the carrier portion of the cartridge and from the inhaler might be the solution.
Why not?
|
|
|
|
Post by oldfishtowner on Jul 12, 2017 8:23:17 GMT -5
I'm guessing the FDA would require a whole new trial to demonstrate that what you suggest is safe and effective. Why? It is the same device and the same active ingredient? The only difference is a person assembling the cartridge rather than a machine. So what is the "clinical trial" - having 100 people assemble 100 cartridges and then testing the cartridges to see if they operate properly? |
|
|
|
Post by thall on Jul 12, 2017 8:26:36 GMT -5
I deleted my comment because I misunderstood your original post; I thought you were wanting to devise a method for patients to make doses other than 4, 8, 12. But I'm afraid I don't see what you're getting at in terms of saving money. Is the packaging the main expense?
|
|
|
|
Post by matt on Jul 12, 2017 8:44:14 GMT -5
I'm guessing the FDA would require a whole new trial to demonstrate that what you suggest is safe and effective. Why? It is the same device and the same active ingredient? The only difference is a person assembling the cartridge rather than a machine. So what is the "clinical trial" - having 100 people assemble 100 cartridges and then testing the cartridges to see if they operate properly? It likely wound not need a completely new trial, but it would require more testing than you might think. Products are designed to be used in a particular way, and FDA approves them based on that design, but what you are talking about is a user invented hack. At a minimum FDA would require a human factors study to determine how often the components get assembled incorrectly as this would affect the dose delivered to the patient. Similarly, expanding the label to pediatric use would require a showing that children above a certain age can assemble the device reliably without adult supervision. So long as the manufacturer can show that the redesigned device / disposable combination gives equivalent results without an increase in medication errors FDA should allow it onto the market, but it is up to the manufacturer to demonstrate those assumptions are valid through testing with actual patients. |
|
|
|
Post by oldfishtowner on Jul 12, 2017 9:14:05 GMT -5
I deleted my comment because I misunderstood your original post; I thought you were wanting to devise a method for patients to make doses other than 4, 8, 12. But I'm afraid I don't see what you're getting at in terms of saving money. Is the packaging the main expense? The primary reason would be to simplifying dosing and writing the prescription without having to figure out which kits and how many of each comes closest to the patient's needs. And secondly to reduce the amount of refrigerated space needed in the distributor's warehouse and in the pharmacy. There should be some savings, but I am not sure significant it would be. When and if Afrezza becomes popular, it would reduce the number of "packages" needed to one bulk package of x number of "cube" blister packs of each dose size to be distributed to pharmacies with the pharmacy being able to dispense any number of each unit size as required - just as they do for pills. It just seems to me that this would simplify manufacturing, distribution and prescribing significantly over what the situation is today. |
|
|
|
Post by thall on Jul 12, 2017 9:22:00 GMT -5
Okay, I see your point. Makes sense if it's possible. "matt" raises a valid point about FDA might require some validation of users ability to accomplish proper dosing.
|
|
|
|
Post by BlueCat on Jul 12, 2017 11:13:24 GMT -5
Natural, TS insulin in Whole Foods bulk bins.
Shakin' head ....
|
|
|
|
Post by lakon on Jul 12, 2017 12:32:22 GMT -5
Why? It is the same device and the same active ingredient? The only difference is a person assembling the cartridge rather than a machine. So what is the "clinical trial" - having 100 people assemble 100 cartridges and then testing the cartridges to see if they operate properly? It likely wound not need a completely new trial, but it would require more testing than you might think. Products are designed to be used in a particular way, and FDA approves them based on that design, but what you are talking about is a user invented hack. At a minimum FDA would require a human factors study to determine how often the components get assembled incorrectly as this would affect the dose delivered to the patient. Similarly, expanding the label to pediatric use would require a showing that children above a certain age can assemble the device reliably without adult supervision. So long as the manufacturer can show that the redesigned device / disposable combination gives equivalent results without an increase in medication errors FDA should allow it onto the market, but it is up to the manufacturer to demonstrate those assumptions are valid through testing with actual patients. Let's be clear. The FDA does not regulate what I do. Sure, if MNKD wanted to create and market something like this, the FDA may have something to say about it, kind of like those refactored heroin overdose kits from AMPH. On the other hand, if patients and/or doctors drive change themselves, the FDA can do very little without overstepping its authority -- something unlikely to go very far under the new administration. That said, I think that people messing around with 2 IU have yet to understand what Afrezza is slowly proving about insulin -- you don't know jack, even if you read it from a book. |
|
|
|
Post by oldfishtowner on Jul 12, 2017 13:31:47 GMT -5
Why? It is the same device and the same active ingredient? The only difference is a person assembling the cartridge rather than a machine. So what is the "clinical trial" - having 100 people assemble 100 cartridges and then testing the cartridges to see if they operate properly? It likely wound not need a completely new trial, but it would require more testing than you might think. Products are designed to be used in a particular way, and FDA approves them based on that design, but what you are talking about is a user invented hack. At a minimum FDA would require a human factors study to determine how often the components get assembled incorrectly as this would affect the dose delivered to the patient. Similarly, expanding the label to pediatric use would require a showing that children above a certain age can assemble the device reliably without adult supervision. So long as the manufacturer can show that the redesigned device / disposable combination gives equivalent results without an increase in medication errors FDA should allow it onto the market, but it is up to the manufacturer to demonstrate those assumptions are valid through testing with actual patients. My response was meant to to say that the testing required would not rise to the expense or complexity of a double blind placebo controlled clinical study. Even if a human factors study is required, it should be rather straight forward. All we are asking patients or their adult care givers to do is color match (and/or match number of units) of the cube containing the TI dose with that of the empty cartridge and insert the cube into the cartridge. As for children, since when do young, children take medication without adult supervision? In a school setting, at least where I live, the school nurse dispenses meds, the students don't carry them around in their backpacks. I am also presuming that the parents could "load" the cartridge with the cube of TI, so that what the child sees is the same as the present packaging. Again, I as said before, a week's supply of cartridges could be loaded with TI at a time. Most older children (12-17 yrs old) should be able to do this themselves. I don't know about you, but when I was that age I could build a model car or airplane with very small parts and follow directions to put the pieces in the right locations. Or paint by the numbers. I don't see a particular impediment. I don't see the study as an impediment. But maybe there are other aspects I have not thought of that would be an impediment. I would particularly like to hear comments regarding whether packaging the TI itself separately from the cartridge would be an improvement or not. |
|
|
|
Post by traderdennis on Jul 12, 2017 15:48:08 GMT -5
seems like it would be a cleanliness issue to make sure that no foreign particles enter the new cartridge. Not that there is much to sue over these days, but I could see legal issues.
Also I am not a patent attorney, giving instructions on modifying their products with patents may invalidate those.
|
|
