Expiration of ibuprofen
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Expiration of Ibuprofen: Efficacy, Stability, and Safety
Chemical Potency and Physical Stability of Expired Ibuprofen
Research indicates that ibuprofen retains its chemical potency and physical stability for up to two years post-expiry. A study investigating various analgesic agents, including ibuprofen, found that the active ingredient remained within the accepted range as per the Indian Pharmacopoeia (IP) during the study period. This suggests that ibuprofen maintains its chemical integrity and physical properties well beyond its labeled expiration date2.
Efficacy of Expired Ibuprofen
The efficacy of expired ibuprofen has been a subject of investigation, with mixed results. One study using the fresh egg albumin-induced mice paw edema method found that expired ibuprofen showed no activity in the first hour but demonstrated some efficacy in subsequent hours. This suggests that while expired ibuprofen may still have some anti-inflammatory effects, its immediate efficacy might be compromised1. Another study using the "Radiant Heat Tail flick" and "Acetic acid-induced writhing" models found no significant difference in the analgesic efficacy of ibuprofen up to two years post-expiry, indicating that the drug retained its pain-relieving properties2.
Safety Concerns and Toxicity of Expired Ibuprofen
Safety is a critical concern when using expired medications. The same study that evaluated the efficacy of expired ibuprofen also monitored various blood parameters. It was found that expired ibuprofen caused a rise in blood urea levels and a significant drop in blood bilirubin levels, suggesting potential renal and hepatic implications1. Additionally, mechanochemical studies on expired ibuprofen revealed that prolonged milling led to the degradation of ibuprofen into various by-products, which could potentially reduce its pharmaceutical activity and toxicity3.
Conclusion
In summary, while expired ibuprofen may retain its chemical potency and some degree of efficacy for up to two years post-expiry, its immediate effectiveness and safety profile may be compromised. The rise in blood urea levels and significant changes in bilirubin levels indicate potential health risks. Therefore, while expired ibuprofen might still be effective in some cases, caution is advised due to the potential for reduced efficacy and increased toxicity.
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Most relevant research papers on this topic
Evaluation of the Effectiveness of Expired Anti-Inflammatory Medicines in Tropical Africa using Mice
Expired anti-inflammatory drugs may have different effects than their unexpired counterparts, with factors like climate, culture, and environment potentially influencing their effectiveness.
Non-RCT
Animal StudyA study to investigate the chemical potency, physical stability, and efficacy of analgesic agents over a period of two years post their expiry date.
Analgesic drugs in our study retained their chemical potency, physical stability, and analgesic efficacy up to two years after expiry, indicating that the expiry date is not an accurate reflection of its actual shelf life.
Observational StudyMechanochemistry of ibuprofen pharmaceutical.
Mechanochemistry can effectively detoxify expired pharmaceuticals by causing ibuprofen decarboxylation, resulting in the loss of both pharmaceutical activity and toxicity.
Effect of high-dose ibuprofen in patients with cystic fibrosis.
High-dose ibuprofen, taken consistently for four years, significantly slows the progression of lung disease in patients with cystic fibrosis without serious adverse effects.
RCT
Highly CitedThe prevalence of ibuprofen-sensitive asthma in children: a randomized controlled bronchoprovocation challenge study.
Ibuprofen-sensitive asthma is present in 2% of school-aged children with mild or moderate asthma, highlighting the need to consider ibuprofen-induced bronchospasm before administering ibuprofen.
RCTExcretion of ibuprofen into breast milk.
In lactating women who take up to 400 mg of ibuprofen every 6 hours, less than 1 mg of ibuprofen per day is excreted in breast milk.
Non-RCTHighly CitedEffect of Temperature on the Stability and Release Profile of Ibuprofen Microcapsules
Ibuprofen microcapsules are stable and release their drug effectively at temperatures below 4°C, with aqueous microcapsules being more stable than organic microcapsules.
Corrosion inhibition effect of expired ibuprofen drug on copper in sulfuric acid solution
Expirated ibuprofen effectively protects copper from corrosion in sulfuric acid solutions, with its inhibitory efficacy increasing with concentration.
A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain.
Intravenous ibuprofen 400 mg every 6 hours significantly reduces postoperative pain and morphine use, potentially reducing opioid requirements.
RCT
Large Human TrialHighly CitedIntravenous Ibuprofen
Intravenous ibuprofen reduces morphine consumption and provides better pain relief than placebo, with the most common adverse event being pruritus.
RCTLarge Human Trial