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Marine-Derived Omega-3 Fatty Acids and Cardiovascular Disease
Published in Stephen T. Sinatra, Mark C. Houston, Nutritional and Integrative Strategies in Cardiovascular Medicine, 2022
Thomas G. Guilliams, Jørn Dyerberg
Fish oil oxidation is measured using two methods. The first measures oxidized fatty acids directly as a peroxide value (PV or POV). Since these peroxides are transient and can form secondary oxidized molecules, such as aldehydes, a second test is used to detect these oxidized compounds: the anisidine (or p-anisidine) test. By adding the anisidine value to twice the peroxide value (AV+2PV), we get the TOTOX value, which allows for evaluating an oil’s rancidity.97 To control the oxidation of the oil raw material and finished product, most manufacturers add a variety of antioxidants. The most popular are vitamin E, vitamin A, flavonoids, and rosemary or other spice extracts; synthetic antioxidants are rarely used. Most commercially available products contain one or more of these antioxidants, at very low doses, in the finished product. Manufacturers of liquid-filled bottles or softgel capsules also utilize nitrogen (to purge available oxygen), low light and cold temperatures in the manufacturing process to reduce oxidation and extend shelf life. Products that have passed their expiration date should be thrown away, as oxidized fish oil can act as a pro-oxidant and limit the benefits realized if consumed.98,99
RADIESSE®
Published in Jani van Loghem, Calcium Hydroxylapatite Soft Tissue Fillers, 2020
Oumama Draoui, Jani van Loghem, Wouter J. Peeters, Pieter Siebenga
Packaged RADIESSE injectable implant should be stored at a controlled room temperature between 15°C and 32°C (59°F and 90°F). Do not use if the expiration date has been exceeded. The expiration date is printed on the product labels.
Quality Control and Quality Assurance
Published in Niel T. Constantine, Johnny D. Callahan, Douglas M. Watts, Retroviral Testing, 2020
Niel T. Constantine, Johnny D. Callahan, Douglas M. Watts
If the laboratory would like to assign a lot number and expiration date to the pool, the following suggestion may be useful: a 1-year supply of a borderline reactor control that was prepared on 7 Dec 91 could be assigned lot number BR71291 (the number corresponds to the preparation date) and given an expiration date of 7 Dec 92. Under the proper storage conditions of -20°C, the control is actually stable for longer periods. The expiration date, in this case, serves only as an indicator as to when the new batch should be prepared, and does not indicate that the control will actually deteriorate on that date.
Device Development for Biosimilars: Human Factor Engineering for a Teriparatide Pen
Published in Expert Opinion on Biological Therapy, 2022
Ronak Patel, Pravin Nair, Meenal Bhatnagar, Sridevi Khambhampaty, Suresh Gupta
The analysis of the use errors observed with the safety critical and essential tasks suggested that the likelihood of actual harm or a compromised dose caused by these use errors was not significant. For most of the use errors observed in the study, a sequence of other failures needed to happen before the use errors could actually result in any harm or compromise to the patients or other users. For example, if a user forgets to check the expiration date on the pen, it is less likely that the user would inadvertently administer expired medicine to themselves causing systemic reaction because, for this harm to happen, a sequence of other failures have to happen, e.g. their pharmacist would provide them with a product whose expiry date is closer to 28 days and the user would use the pen for more than 28 days (which is not recommended). Furthermore, even if the user injects themselves with a pen whose expiration date has passed, the drug may not degrade to a harmful level to cause systemic reaction. Therefore, the likelihood of the observed use errors resulting in actual harm or compromised treatment was relatively low.
Quality Assessment of Expired Naloxone Products from First-Responders’ Supplies
Published in Prehospital Emergency Care, 2019
Schuyler Pruyn, Justin Frey, Benjamin Baker, Michael Brodeur, Carla Graichen, Heather Long, Haian Zheng, Michael Winter Dailey
The implication of effectiveness and safety of a medication beyond its expiration date brings a reasonable solution to potential future drug shortages and costs. Additionally, once we deploy medications including naloxone into an uncontrolled environment and to people who use drugs, their family and friends, as well as law enforcement, it increases the need for drug stability research under controlled challenging environments, to simulate the real situations in cars, ambulances, garages, or extremes of weather. Also, with new formulations of naloxone becoming available, there must be testing to assure the universality of these findings. Because of the demonstrated apparent stability of naloxone and subsequently its potential ability to maintain a longer shelf life, there is the opportunity to decrease the cost burden to both the public in the distribution of this medication and increase public access.
Expired Epinephrine Maintains Chemical Concentration and Sterility
Published in Prehospital Emergency Care, 2018
William Bradley Weir, Linda Y. Fred, Matthew Pike, Stanislav S. Rubakhin, Tyler J. Ludwig, Ashley M. Shar, Lingyang Zhu, Ann Frederick, Ike Uzoaru, Lin Wang, Jonathan V. Sweedler
Our data have additional support from results of the Shelf Life Extension Program (SLEP), which has also shown that many medications are viable past their labeled expiration dates (5). The SLEP is a federal program to extend the expiration date of medications for use by the Department of Defense and the Strategic National Stockpile by routinely testing samples from the appropriate medication lots. Over 50% of the medications tested by the SLEP have their expiration date extended by at least a year but the program has found a significant amount of lot-to-lot variability for any specific medication (5).