Posted: 5/6/2011 8:32:22 AM EDT
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How long are they good for in a stable environment? |
| Pharmacist friend say one year past expiration and it will loose strength. waiting to here back how much loss but I'm sure it will depend on storage conditions, Also asked about toxicity at older age but I don't think there is any. Think its penicillin based. Waiting to here back. |
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Lots of good information here: http://www.ar15.com/forums/topic.html?b=10&f=17&t=633930&light=antibiotic Most ABX are good past their expiration date assuming proper storage. |
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Quoted: Pharmacist friend say one year past expiration and it will loose strength. waiting to here back how much loss but I'm sure it will depend on storage conditions, Also asked about toxicity at older age but I don't think there is any. Think its penicillin based. Waiting to here back. Okay. I know that some drugs do expire on the date given but in a SHTF deal I could go past the date at least a little. Z-Paks aren't something I ever thought about rotating since they have been largely unavailable due to price. It might also help if I had more than two cans of corn in the pantry as well.  |
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Pharmacist friend say one year past expiration and it will loose strength. waiting to here back how much loss but I'm sure it will depend on storage conditions, Also asked about toxicity at older age but I don't think there is any. Think its penicillin based. Waiting to here back. Okay. I know that some drugs do expire on the date given but in a SHTF deal I could go past the date at least a little. Z-Paks aren't something I ever thought about rotating since they have been largely unavailable due to price. It might also help if I had more than two cans of corn in the pantry as well.
If you really only have two cans of corn, you may need to re-prioritize. |
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First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread.
There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. |
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Quoted:
First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread. There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. A few things to add the expiration date on the package is the date the manufacturer is liable for the potency. It can be a marketing decision not to extend the date out longer. Many times generic company’s want to get to market quickly so they will only have 24 months of real time data so that is what they will go to market with. They may extend to 36 months but that is after the launch. A brand drug may have enough data to ask for 36 months dating at the time of filing. Most drug companies will not put more than 36 months from date of manufacture due to the fact that the drugs will be moved through the supply chain before that date. If they put a longer expiration date they run the risk of having a stability failure and then a recall. Many drugs will have a potency spec of 95-105 %. There are also things called impurities and degradants that are tested throughout the shelf life. If one of them goes too high the drug fails and is considered out of spec. You can have impurities with limits of 0.1%. Sometimes the potency is the issue other times it is the impurities. As LRHogFan said storage does make a difference. The worst thing you can do is store a drug in high heat or humidity. The other thing to stress is that the original manufacturer’s container is what the studies are done on. What the pharmacists puts it in when he dispenses the meds to you is not what the manufacture does his study on. |
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First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread. There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. A few things to add the expiration date on the package is the date the manufacturer is liable for the potency. It can be a marketing decision not to extend the date out longer. Many times generic company’s want to get to market quickly so they will only have 24 months of real time data so that is what they will go to market with. They may extend to 36 months but that is after the launch. A brand drug may have enough data to ask for 36 months dating at the time of filing. Most drug companies will not put more than 36 months from date of manufacture due to the fact that the drugs will be moved through the supply chain before that date. If they put a longer expiration date they run the risk of having a stability failure and then a recall. Many drugs will have a potency spec of 95-105 %. There are also things called impurities and degradants that are tested throughout the shelf life. If one of them goes too high the drug fails and is considered out of spec. You can have impurities with limits of 0.1%. Sometimes the potency is the issue other times it is the impurities. As LRHogFan said storage does make a difference. The worst thing you can do is store a drug in high heat or humidity. The other thing to stress is that the original manufacturer’s container is what the studies are done on. What the pharmacists puts it in when he dispenses the meds to you is not what the manufacture does his study on. Listen to this man, he knows his stuff |
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First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread. There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. Gee, is it a coincidence that the USP controlled room temperature that is 68-77 degrees F... ...JUST HAPPENS to be the RECOMMENDED storage temp of Z-paks. AND the typical OFFICE environment temp! Wow, the marvels of Nature never cease to amaze me. 
Now, I wonder what the OPTIMUM storage temp for MAXIMUM shelf-life extension for a Z-pak might be, I'm guessing somewhere about 10 to 20 degrees F. 
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First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread. There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. Gee, is it a coincidence that the USP controlled room temperature that is 68-77 degrees F... ...JUST HAPPENS to be the RECOMMENDED storage temp of Z-paks. AND the typical OFFICE environment temp! Wow, the marvels of Nature never cease to amaze me.
Now, I wonder what the OPTIMUM storage temp for MAXIMUM shelf-life extension for a Z-pak might be, I'm guessing somewhere about 10 to 20 degrees F.
If you really want to know if they have any extended stability data for different temperature ranges, call them - Pfizer Medical Information Toll Free: 800-438-1985 Otherwise, store it at recommended temperature levels and re-up when it has exceeded the expiration date. It's not like they are real expensive or anything. Probably less than $40 cash for a generic zpak. |
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First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread. There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. Well I'm a Chem E with a minor in micro, regarding lower temps cause degregation, wanna bet? Z Pak, such a catchy name, is azithromycin. In other words derived from Streptomyces. It is organic. No its not as "sell more" mercenary as some of these guys think. While pill and cap form greatly increases life of product at room temperature over liquid, the selection of recommended storage has way more to do with safety and availability than actual degregation rates. A drug that will last 1 years on a shelf at room temp is far more desirable than one that will last five in a freezer. It all goes to predictability impact from taking something out of the cold environment, how long, and what impact that has on life. Excellent advice on original packaging but you see that's all pill forms and caps really are too, packaging. Tj |
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First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread. There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. Gee, is it a coincidence that the USP controlled room temperature that is 68-77 degrees F... ...JUST HAPPENS to be the RECOMMENDED storage temp of Z-paks. AND the typical OFFICE environment temp! Wow, the marvels of Nature never cease to amaze me.
Now, I wonder what the OPTIMUM storage temp for MAXIMUM shelf-life extension for a Z-pak might be, I'm guessing somewhere about 10 to 20 degrees F.
Most drug will have USP Controled room temp as storage if they can get the data to support it. Many times storing colder the USP CRT can extend the shelf life, but not in all cases. Thats why you need real data to support it. BTW Liquids are less stable then tablets as a genearal rule. Also DO NOT STORE MEDICATIONS IN THE BATH ROOM OR NEAR THE STOVE! The heat and humidity are BAD!! |
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First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread. There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. Gee, is it a coincidence that the USP controlled room temperature that is 68-77 degrees F... ...JUST HAPPENS to be the RECOMMENDED storage temp of Z-paks. AND the typical OFFICE environment temp! Wow, the marvels of Nature never cease to amaze me.
Now, I wonder what the OPTIMUM storage temp for MAXIMUM shelf-life extension for a Z-pak might be, I'm guessing somewhere about 10 to 20 degrees F.
Most drug will have USP Controled room temp as storage if they can get the data to support it. Many times storing colder the USP CRT can extend the shelf life, but not in all cases. Thats why you need real data to support it. BTW Liquids are less stable then tablets as a genearal rule. Also DO NOT STORE MEDICATIONS IN THE BATH ROOM OR NEAR THE STOVE! The heat and humidity are BAD!! Perfect post to explain why recommendations are for what. Organics do indeed degregate faster with higher temperature likewise the opposite is true it slows with lower temperature, however once you cross the freezing point of water, chemically you're in a totally different world then. You just left slowing chemical reaction to possibly introducing a new factor, ice, which can induce sheering. You know to put this all in common understanding, biological chemicals are all just like motor oil. The rules are all very similar. Even if you don't drive your car, you should change the oil once a year. The hotter the oil environment, the more anal you need to be about changing it. That's why cars use to recommend heavier oils in summer. A pill or capsule is the equivalent of a heavier oil. It removes the moisture content you speak of so increases the shelf life at temperature for a given chemical. Where I can tell you dropping your storage temp 20 degrees or so from room temperature can only help, I most certainly can't once you cross the freezing point. Using my simple example, even motor oil below freezing point what pure moisture content it has at a certain point will freeze. Those ice crystals then will introduce at a minimum sheering (splitting). Thus the problem of the old liquid antibiotics. Every time you take it out and put it back in, it will degregate. Now a pharmacy or a hospital is a controlled environment, while at home its not and gramdma may leave it out too long speeding up the process. Tj |
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First of all, I am a pharmacist and feel that I am capable of answering most of the questions in this thread. There seems to be a little misinformation about storage and expiration of drugs. Most medications are to be stored at USP controlled room temperature. That is 68-77 degrees F, with excursions allowed from 59-86 degrees F. Think about it, when you walk into a pharmacy, are their drugs stored on the shelf, or in a refrigerator. Most of them are stored on a shelf at controlled room temperature. There are a few drugs that are kept refrigerated, but most of those are biologics or other type medications that require refrigeration. I can't say for certain, but keeping azithromycin or Zpaks in the fridge, may actually shorten their life expectancy. From the Zithromax package insert - ZITHROMAX tablets should be stored between 15 to 30C (59 to 86F).
As far as the expiration goes, the product expiration dates are determined by the company during degradation studies. As I was taught in school, the expiration date on the bottle or package reflects the point that the drug can be expected to reach 90% of it's original stated strength. Optimally, you would want to purchase the medication in quantities so that you can get an original unopened container, this will ensure that it does not degrade at a faster rate due to introduction of moisture or sunlight into the container. Both of those environmental factors can speed up the degradation process. I may have missed some points, but if you have any questions, please feel free to ask. Well I'm a Chem E with a minor in micro, regarding lower temps cause degregation, wanna bet? Z Pak, such a catchy name, is azithromycin. In other words derived from Streptomyces. It is organic. No its not as "sell more" mercenary as some of these guys think. While pill and cap form greatly increases life of product at room temperature over liquid, the selection of recommended storage has way more to do with safety and availability than actual degregation rates. A drug that will last 1 years on a shelf at room temp is far more desirable than one that will last five in a freezer. It all goes to predictability impact from taking something out of the cold environment, how long, and what impact that has on life. Excellent advice on original packaging but you see that's all pill forms and caps really are too, packaging. Tj Nowhere above did I say for certain that azithromycin degraded faster at lower temps. I said that it "may" degrade faster. I don't have any data either way, just letting people know what the manufacturer's recommended storage ranges are. Take your chemistry degree and learn to spell degrade. |
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<snip> Nowhere above did I say for certain that azithromycin degraded faster at lower temps. I said that it "may" degrade faster. I don't have any data either way, just letting people know what the manufacturer's recommended storage ranges are. Take your chemistry degree and learn to spell degrade. Not very nice there, over a typo, eh? We generally try not to snark at each other here in the SF––it's not GD after all. It's fine to 'agree to disagree', but we do our best to keep things civil. Word to the wise.
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Something that LRHog hit on that may alter the shelf life of drugs is the temp swings that occur with fridges. Most lay peoples fridges have drastic swings in temp with use and are generally not suitable for long term drug storage. I know that every facility I have worked at there were specially designated drug fridges that were monitored to ensure that the temps remained constant.
Even though we may not be able to rationalize why something is done a certain way in medicine as lay people does not mean there are not reasons and hat it is ok to do or not do something. Pharmacists are experts in drug dispensing and handling, considering every physician I have ever worked with has always deferred to the pharmacist's recommendations I would place great trust in their thoughts when it concerns medications. To blow off an expert's opinion in their field of expertise strikes me as pure hubris. I would like to thank all the medical professionals for devoting their time to further the survival forums efforts. Evidence based practice is the motto of medicine for good reason. My two cents. MrHunterAZ RN, Infusion Therapy (Sorry for the grammar, posted via mobile.) |
| I wonder how packing in a mylar bag with O2 absorbers would affect longevity? If O2 was responsible for degradation of the item in any small way, this would really slow that down. Not to mention a humidity and light barrier. The plastic bottles in much of the pharm don't seem to be very O2 resistant. |
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<snip> Nowhere above did I say for certain that azithromycin degraded faster at lower temps. I said that it "may" degrade faster. I don't have any data either way, just letting people know what the manufacturer's recommended storage ranges are. Take your chemistry degree and learn to spell degrade. Not very nice there, over a typo, eh? We generally try not to snark at each other here in the SF––it's not GD after all. It's fine to 'agree to disagree', but we do our best to keep things civil. Word to the wise.
I apologize for my snappy reply, I will do my best to maintain a degree of civility in this sub-forum. |
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Just a few more things to add:
The manufacturer may do a freeze thaw study during development. If there is an issue you would very likely see a “do not freeze” on the package. Generally, it is not a good idea to freeze RX drugs. As for the O2 Absorbers if the product is sensitive to o2 there should be one in the MANUFACURERS bottle. However I don’t think it would typically hurt anything. The manufacturers do not like to add them if they do not have to since it is one more thing to add in production and adds cost. There are desiccants added to many bottles if the product is sensitive to humidity. Another thing that is sometimes done is to bottle is to add a nitrogen blanket. Also they would have a foil seal on the bottle. If you are looking to store see if you can get the manufacturers bottle with the seal intact. Many drugs are sold by the manufacture in a 90 and 30 counts. |
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You might also want to look into the Army's Shelf Life Extension Program (SLEP.)
They've worked with the FDA to track drug efficacy after extended storage. I know several antibiotics had no failures (ie tested after storage as within acceptable limits) around 5 years past expiration. Storage environment was key, and repackaged medicines did far worse than original packages, but the documentation I read didn't describe what, if any, steps were taking to preserve repackaged meds. Cipro, for example, is apparently very stable. With "normal" storage (i.e. nothing other than standard storage guidlines, room temps, etc.) The FDA SLEP tested a batch of Cipro made in 1989 in 1999, and endorsed another two-year extension to their shelf life –– so 12 years, with no special storage. In a story I read about this particular set of tests, Bayer went on record that they'd expect the shelf life to be much longer than marked on the package, and that the package marked expiration date had more to do with legal liability and making sure the printed documentation with the Cipro was up-to-date than due to its chemical stability! I've packed away some Cipro among others, and while I've found plenty of warnings not to freeze, I've never found any reason outside of the packaging supporting the warning. I have found documentation supporting that freezing caused no harmful effects to samples down to -20C, so I'm comfortable with the choice to freeze. In any case, based on chemistry and SLEP data, none of my research turned up any reason conventional dry-form antibiotics couldn't be taken down to near-freezing in a refrigerator and enjoy a significant extension to shelf life. YMMV, of course –– I'm not a professional pharmicist or chemist, but I am a professional in technical research and analysis. FYI, freezing a huge no-no for liquid form antibiotics, however. |
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From the big antibiotic thread: Quoted: Quoted: Quoted: Quoted: I have cipro and some doxycycline among others....If kept in a cool dry cabnet how long past the exp date are they good for? Double zip lock bag them in the original bottles and placed in your freezer they will last 10 years or more. Why would you freeze them??? Not to be rude, but please don't make statements that aren't true. DO NOT freeze them. Keep at room temp, as the bottle/manufacturer indicates. Drug degradation rate is highly dependent on temperature as well as moisture, light exposure, excipients etc. The colder you can store them the longer they will last. There are a few exceptions such as in liquid formulations where freezing can cause drug precipitation and result in reduced oral absorption. In the case of biologic based drugs (proteins, antibodies etc) freezing can lead to denaturation with complete loss of activity. The vast majority of drugs provided in pill/capsule form can be stored frozen and the colder the better. By the way, I’m a medicinal chemist who has spent the last 25 years or so designing and synthesizing new drugs in the anti-infective and oncology disease areas. |
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Just a few more things to add: The manufacturer may do a freeze thaw study during development. If there is an issue you would very likely see a “do not freeze” on the package. Generally, it is not a good idea to freeze RX drugs. Z packs are allready frozen. I have no idea what temperature they melt at, I'd gesss well above 500 degrees F. Freezing is generally a problem for only 3 reasons: 1) the freezing causes percipitation out of solution (liquids) or seperation (gells/ointment), 2) The freezing causing loss of packaging integrity (injectables typically, but it could well be burst packets of ointment). 3) The freezing causes some change to the unit dose (gel caps rupture, microspheres in time release drugs ruptures, etc). Despite lots of looking, I have never found a case of freezing having any effect on solid dose froms. There was a huge review of literature financed by the army because of the concerns of pushing drugs towards the front lines during a war in a cold climate (ie Korea). They found no issues for solid does forms. I've talking to several pf the PharmDs workign for CDC on the Strategic National Stockpile and they don't know of any issues. As to the 90% rule, the expiration date isn't when it reaches 90%, it's that every batch must be proven not to be less then 90% at the end of the expiration date. Some drugs have know know mechanism to degrade. What date would you put on saline? 10 years? 1000 years? 10 million years? It's the packaging thats going to fail first, so you put a reasonable number on it and prove that number. As to cold making drugs fail faster, for solid dose froms, there i no evidence of that. Specifically, CDC, the USPS, state departments of public health and the military routinly store drugs under conditions below USP. These drugs are periodically tested under the service life extension program (SLEP) many of the drugs have been extended, none have been found to have shorter lives. Not to mention there is no known mechanism that would cause the resuced life (except loss of packaging integrity, which I have been told is a minor concern for IV bags that may be handled by forklift. |