Predicting rapid analgesic onset of ibuprofen salts compared with ibuprofen acid: T_lag, T_low, T_med, and a novel parameter, T_CmaxRef

References

• Rainsford KD. Discovery, mechanisms of action and safety of ibuprofen. Int J Clin Pract Suppl 2003;135:3-8
   Google Scholar
• Rainsford KD. Ibuprofen: from invention to an OTC therapeutic mainstay. Int J Clin Pract Suppl 2013;178:9-20
   Google Scholar
• Rainsford KD. Ibuprofen: pharmacology, efficacy and safety. Inflammopharmacology 2009;17:275-342
   PubMedGoogle Scholar
• Reckitt Benckiser. Summary of product characteristics: Nurofen 200 mg tablets. PL 00063/0385. 2003. Updated 2015. EMC, Leatherhead, Surrey, UK. Available online at: https://www.medicines.org.uk/emc/medicine/24209. Accessed September 27, 2016
   Google Scholar
• Reckitt Benckiser. Summary of product characteristics: Nurofen Express 200 mg liquid capsules. PL 00063/0648. 2008. Updated 2016. EMC, Leatherhead, Surrey, UK. Available online at: https://www.medicines.org.uk/emc/medicine/23387. Accessed September 27, 2016
   Google Scholar
• Reckitt Benckiser. Summary of product characteristics: Nurofen Express 256 mg caplets (GSL). PL 00063/0374. 2008. Updated 2016. EMC, Leatherhead, Surrey, UK. Available online at: https://www.medicines.org.uk/emc/medicine/23581. Accessed September 27, 2016
   Google Scholar
• Reckitt Benckiser. Summary of product characteristics: Nurofen Express 342 mg caplets. PL 00063/0380. 2009. Updated 2012. EMC, Leatherhead, Surrey, UK. Available online at: https://www.medicines.org.uk/emc/medicine/20099. Accessed September 27, 2016
   Google Scholar
• Moore RA, Wiffen PJ, Derry S, et al. Non-prescription (OTC) oral analgesics for acute pain – an overview of Cochrane reviews. Cochrane Database Syst Rev 2015;11:CD010794
   Google Scholar
• Moore N, Pollack C, Butkerait P. Adverse drug reactions and drug–drug interactions with over-the-counter NSAIDs. Ther Clin Risk Manag 2015;11:1061-75
   PubMed Web of Science ®Google Scholar
• Duong M, Salvo F, Pariente A, et al. Usage patterns of ‘over-the-counter’ vs prescription-strength nonsteroidal anti-inflammatory drugs in France. Br J Clin Pharmacol 2014;77:887-95
   PubMed Web of Science ®Google Scholar
• Sarganas G, Buttery AK, Zhuang W, et al. Prevalence, trends, patterns and associations of analgesic use in Germany. BMC Pharmacol Toxicol 2015;16:28
   PubMed Web of Science ®Google Scholar
• Connelly D. The OTC market in Britain in 2015. Pharm J 2016;296:7887
   Google Scholar
• Statista. Leading internal analgesic tablet brands in the United States in 2017, based on sales. 2018, Hamburg, Germany. Available online at: https://www.statista.com/statistics/194510/leading-us-analgesic-tablet-brands-in-2013-based-on-sales/. Accessed April 10, 2018
   Google Scholar
• Castellsague J, Riera-Guardia N, Calingaert B, et al. Individual NSAIDs and upper gastrointestinal complications: a systematic review and meta-analysis of observational studies (the SOS project). Drug Saf 2012;35:1127-46
   PubMed Web of Science ®Google Scholar
• McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med 2011;8:e1001098
   PubMed Web of Science ®Google Scholar
• Varas-Lorenzo C, Riera-Guardia N, Calingaert B, et al. Stroke risk and NSAIDs: a systematic review of observational studies. Pharmacoepidemiol Drug Saf 2011;20:1225-36
   PubMed Web of Science ®Google Scholar
• Varas-Lorenzo C, Riera-Guardia N, Calingaert B, et al. Myocardial infarction and individual nonsteroidal anti-inflammatory drugs meta-analysis of observational studies. Pharmacoepidemiol Drug Saf 2013;22:559-70
   PubMed Web of Science ®Google Scholar
• Davies NM. Clinical pharmacokinetics of ibuprofen. The first 30 years. Clin Pharmacokinet 1998;34:101-54
   PubMed Web of Science ®Google Scholar
• Geisslinger G, Dietzel K, Bezler H, et al. Therapeutically relevant differences in the pharmacokinetical and pharmaceutical behavior of ibuprofen lysinate as compared to ibuprofen acid. Int J Clin Pharmacol Ther Toxicol 1989;27:324-8
   PubMed Web of Science ®Google Scholar
• Sorgel F, Fuhr U, Minic M, et al. Pharmacokinetics of ibuprofen sodium dihydrate and gastrointestinal tolerability of short-term treatment with a novel, rapidly absorbed formulation. Int J Clin Pharmacol Ther 2005;43:140-9
   PubMed Web of Science ®Google Scholar
• Dewland PM, Reader S, Berry P. Bioavailability of ibuprofen following oral administration of standard ibuprofen, sodium ibuprofen or ibuprofen acid incorporating poloxamer in healthy volunteers. BMC Clin Pharmacol 2009;9:19
   PubMedGoogle Scholar
• Norholt SE, Hallmer F, Hartlev J, et al. Analgesic efficacy with rapidly absorbed ibuprofen sodium dihydrate in postsurgical dental pain: results from the randomized QUIKK trial. Int J Clin Pharmacol Ther 2011;49:722-9
   PubMed Web of Science ®Google Scholar
• Moore RA, Derry S, Straube S, et al. Faster, higher, stronger? Evidence for formulation and efficacy for ibuprofen in acute pain. Pain 2014;155:14-21
   PubMed Web of Science ®Google Scholar
• Nerella NG, Block LH, Noonan PK. The impact of lag time on the estimation of pharmacokinetic parameters. I. One-compartment open model. Pharm Res 1993;10:1031-6
   PubMed Web of Science ®Google Scholar
• Endrenyi L, Tothfalusi L. Metrics for the evaluation of bioequivalence of modified-release formulations. AAPS J 2012;14:813-9
   PubMed Web of Science ®Google Scholar
• Mehlisch DR, Sykes J. Ibuprofen blood plasma levels and onset of analgesia. Int J Clin Pract Suppl 2013;178:3-8
   Google Scholar
• World Medical Association. Declaration of Helsinki – ethical principles for medical research involving human subjects. 1964. Updated 2013. Ferney-Voltaire, France. Available online at: http://www.wma.net/en/30publications/10policies/b3/. Accessed September 27, 2016
   Google Scholar
• International Council for Harmonisation. ICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice E6 (R1). 1996. Geneva, Switzerland. Available online at: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf. Accessed September 27, 2016
   Google Scholar
• Williams E. Experimental designs balanced for the estimation of residual effects of treatments. Aus J Sci Res 1949;2:149-68
   Google Scholar
• Stillings M, Little S, Sykes J. Common cold and influenza symptom management: the use of pharmacokinetic considerations to predict the efficacy of a twice-daily treatment for colds and flu. Curr Med Res Opin 2003;19:791-9
   PubMed Web of Science ®Google Scholar
• Dollery C. Acetaminophen monograph. In: Dollery C, editor. Therapeutic drugs. 2nd ed. London: Churchill Livingstone; 1999. p A19-21
   Google Scholar
• Rumack BH. Aspirin versus acetaminophen: a comparative view. Pediatrics 1978;62(5 Pt 2 Suppl):943-6
   PubMed Web of Science ®Google Scholar
• Wilcoxon F. Individual comparisons by ranking methods. Biom Bull 1945;1:80-3
   Google Scholar
• Hodges J, Lehmann E. Estimates of location based on rank tests. Ann Math Statist 1963;34:598-611
   Google Scholar
• Lipton RB, Hamelsky SW, Dayno JM. What do patients with migraine want from acute migraine treatment? Headache 2002;42(Suppl 1):3-9
   PubMed Web of Science ®Google Scholar
• Schleier P, Prochnau A, Schmidt-Westhausen AM, et al. Ibuprofen sodium dihydrate, an ibuprofen formulation with improved absorption characteristics, provides faster and greater pain relief than ibuprofen acid. Int J Clin Pharmacol Ther 2007;45:89-97
   PubMed Web of Science ®Google Scholar
• Bjarnason I, Sancak O, Crossley A, et al. Differing disintegration and dissolution rates, pharmacokinetic profiles and gastrointestinal tolerability of over the counter ibuprofen formulations. J Pharm Pharmacol 2018;70:223-33
   PubMed Web of Science ®Google Scholar
• Moore A, Crossley A, Ng B, et al. Use of multicriteria decision analysis for assessing the benefit and risk of over-the-counter analgesics. J Pharm Pharmacol 2017;69:1364-73
   PubMed Web of Science ®Google Scholar
• Bookstaver PB, Miller AD, Rudisill CN, et al. Intravenous ibuprofen: the first injectable product for the treatment of pain and fever. J Pain Res 2010;3:67-79
   PubMedGoogle Scholar
• Smith HS, Voss B. Pharmacokinetics of intravenous ibuprofen: implications of time of infusion in the treatment of pain and fever. Drugs 2012;72:327-37
   PubMed Web of Science ®Google Scholar
• Bergese SD, Candiotti K, Ayad SS, et al. The shortened infusion time of intravenous ibuprofen part 1: a multicenter, open-label, surveillance trial to evaluate safety and efficacy. Clin Ther 2015;37:360-7
   PubMed Web of Science ®Google Scholar
• Laska EM, Sunshine A, Marrero I, et al. The correlation between blood levels of ibuprofen and clinical analgesic response. Clin Pharmacol Ther 1986;40:1-7
   PubMed Web of Science ®Google Scholar