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Is it safe to buy generic online during winter? 8 years 5 months ago #2997
Hi all! I want to buy Harvoni generic from India or Bangladesh using online pharmacy, but worried about stability of drug after possibly freezing during delivery. In my country winter is cold, and drugs may be frozen at post/customs during several days (or even weeks in worst case). Is Harvoni generic sufficiently stable to withstand such freezing without loss of effectiveness? I found that sofosbuvir and ledipasvir alone were tested in Europe in stressed conditions (-20 celsius degree e t.c.) and no sufficient changes were observed. (www.ema.europa.eu/docs/en_GB/document_li...3850/WC500177996.pdf):
But final product, combined sofosbuvir and ledipasvir in one tablet (Harvoni) have "room temperature below 30 celsius" storage conditions. What is reason for it? Will Harvoni lose effictiveness after freezing? What do you think about it? Thank you, Serg Probably infected in 1977 2005 - diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320 2005-2006 - PegIFN/rib 48 weeks treatment, relapse 2016 - compensated F4, MELD 8-9, ALT 100-160 2018 - compensated F4, MELD 8, ALT 91 | |
Is it safe to buy generic online during winter? 8 years 5 months ago #2998
Hello Serg, and welcome to the forum. If the active pharmaceutical ingredients (Sof & Led) can withstand extremely low temperatures, mixing the with a few inert fillers to make them into pills isn't going to change that (or any other of their) medical property. The following user(s) said Thank You: Serg | |
Worried about my meds 8 years 5 months ago #3016
Due to uncertainty and a home with no air-con I have stored my sof+dac in the fridge. I am worried that I may have damaged the chemistry by keeping at a temp too low. Thanks in advance for any advice. | |
Worried about my meds 8 years 5 months ago #3024
Do not worry, your medication will be fine. Please read: fixhepc.com/kunena-2015-11-10/faq.html and the "How do I store my medications" part. Destruction of chemical APIs occurs by heating rather than cooling. Here is the FAQ answer: The original manufacturers of Sofosbuvir, Ledipasvir, Daclatasvir say this in their CMI: Keep HARVONI tablets in a cool, dry place where it stays below 30°C Store DAKLINZA tablets in a cool dry place where the temperature stays below 30°C. More or less all medications say something like this. For reference: Sofosbuvir: Melting point. 95-100 ºC Ledipasvir: Melting Point: 186 - 190ºC Daclatasvir: Melting Point: 166-172°C So you could almost certainly store them at > 30 °C but if you follow the < 30 °C recommendations everything should be fine. The main issue with higher temperatures is that gelatine capsules will melt at 44 °C. The main issue with moisture is that both capsules and tablets are designed to fall apart in your stomach when they get wet. Refrigeration will be fine but does create moisture problems. While a fridge is cool and dry the problem occurs when you have warm moist air (room air) and then cool it causing the moisture to condense - you have probably seen this if you put hot food in the fridge with droplets of moisture rapidly replacing the steam on the lid. You should not freeze the medication although freezing theoretically increases the molecular stability of the APIs, and in fact the NMI certificates found here fixhepc.com/blog/item/16-testing-provisions-patient-safety.html state: Recommended storage When not in use, this material should be stored at or below 4 ºC in a closed container in a dry, dark area. YMMV The following user(s) said Thank You: Serg | |
Is it safe to buy generic online during winter? 8 years 5 months ago #3029
Hello Serg, I will just go out on a limb and say you should not worry - first read the bit of the FAQs about how to store the medications: fixhepc.com/kunena-2015-11-10/faq.html If you think about the science of molecular stability at absolute zero a molecule is stable almost indefinitely because there is no atomic motion and thus no capacity to break down. Heat can destroy a molecule, cold more of less can not destroy small organic molecules, although large organic molecules like for example egg white can be cooked (denatured) by putting them it into liquid nitrogen. Proteins are on a totally different scale to sofosbuvir, ledipasvir and daclatasvir which exist in a crystalline structure like sugar or salt (neither of which are destroyed by cold). Proteins are denatured because the temperature in which they "expect" to exist determines very complex conformations. The breakdown of organic matter due to freezing (say with frostbite) relates to large ice crystals rupturing cell membranes. Snap freezing things like embryos and foods works because the ice crystals formed are so small they do not rupture the cell membranes. Vitamins and co factors are of similar scale to the DAAs and we know that freezing preserves them, where as cooking with heat can damage them. So in other words severe cold can damage very large complex things, but is unlikely to damage small organic molecules like DAAs. Note that ledipasvir is by far the most unstable of the 3 common DAAs - it falls apart in chloroform for example. YMMV | |
Is it safe to buy generic online during winter? 8 years 5 months ago #3075
James, Alsdad - thank you very much! Today I received answer from Gilead about Harvoni storage conditions. They wrote that for -20 celsius acceptable duration of storage is 28 days. It seems good enough. Text of their answer:
Probably infected in 1977 2005 - diagnosed with HCV 1b, compensated F4, 15 mln viral load, ALT 320 2005-2006 - PegIFN/rib 48 weeks treatment, relapse 2016 - compensated F4, MELD 8-9, ALT 100-160 2018 - compensated F4, MELD 8, ALT 91 The following user(s) said Thank You: DrJames | |