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Review

Co-crystal of tramadol-celecoxib: preclinical and clinical evaluation of a novel analgesic

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Pages 399-409 | Received 03 Dec 2018, Accepted 20 Mar 2019, Published online: 03 May 2019

References

  • Goldberg DS, McGee SJ. Pain as a global public health priority. BMC Public Health. 2011;11:770.
  • Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009;9:723–744.
  • Turk DC, Wilson HD, Cahana A. Treatment of chronic non-cancer pain. Lancet. 2011;377:2226–2235.
  • Chang HY, Daubresse M, Kruszewski SP, et al. Prevalence and treatment of pain in EDs in the United States, 2000 to 2010. Am J Emerg Med. 2014;32:421–431.
  • Pletcher MJ, Kertesz SG, Kohn MA, et al. Trends in opioid prescribing by race/ethnicity for patients seeking care in US emergency departments. JAMA. 2008;299:70–78.
  • Mura P, Serra E, Marinangeli F, et al. Prospective study on prevalence, intensity, type, and therapy of acute pain in a second-level urban emergency department. J Pain Res. 2017;10:2781–2788.
  • Sinatra R. Causes and consequences of inadequate management of acute pain. Pain Med. 2010;11:1859–1871.
  • Todd KH, Ducharme J, Choiniere M, et al. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007;8:460–466.
  • Brown JC, Klein EJ, Lewis CW, et al. Emergency department analgesia for fracture pain. Ann Emerg Med. 2003;42:197–205.
  • Gregory J, McGowan L. An examination of the prevalence of acute pain for hospitalised adult patients: a systematic review. J Clin Nurs. 2016;25:583–598.
  • Apfelbaum JL, Chen C, Mehta SS, et al. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97:534–540.
  • Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006;367:1618–1625.
  • Raffa RB, Pergolizzi JV Jr., Tallarida RJ. The determination and application of fixed-dose analgesic combinations for treating multimodal pain. J Pain. 2010;11:701–709.
  • Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists‘ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17:131–157.
  • Polomano RC, Fillman M, Giordano NA, et al. Multimodal analgesia for acute postoperative and trauma-related pain. Am J Nurs. 2017;117:S12–26.
  • Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010;23:697–703.
  • O‘Brien J, Pergolizzi J Jr., van de Laar M, et al. Fixed-dose combinations at the front line of multimodal pain management: perspective of the nurse-prescriber. Nurs Res Rev. 2013;3:9–22.
  • Thipparaboina R, Kumar D, Chavan RB, et al. Multidrug co-crystals: towards the development of effective therapeutic hybrids. Drug Discov Today. 2016;21:481–490.
  • Duggirala NK, Perry ML, Almarsson O, et al. Pharmaceutical cocrystals: along the path to improved medicines. Chem Commun (Camb). 2016;52:640–655.
  • Thakuria R, Delori A, Jones W, et al. Pharmaceutical cocrystals and poorly soluble drugs. Int J Pharm. 2013;453:101–125.
  • Cheney ML, Shan N, Healey ER, et al. Effects of crystal form on solubility and pharmacokinetics: a crystal engineering case study of lamotrigine. Cryst Growth Des. 2010;10:394–405.
  • Shan N, Perry ML, Weyna DR, et al. Impact of pharmaceutical cocrystals: the effects on drug pharmacokinetics. Expert Opin Drug Metab Toxicol. 2014;10:1255–1271.
  • Sherman B, Solid substances comprising valproic acid and sodium valproate. U.S. Patent 6077542. 2000
  • Maeno Y, Fukami T, Kawahata M, et al. Novel pharmaceutical cocrystal consisting of paracetamol and trimethylglycine, a new promising cocrystal former. Int J Pharm. 2014;473:179–186.
  • Videla S, Lahjou M, Vaque A, et al. Single-dose pharmacokinetics of co-crystal of tramadol-celecoxib: results of a four-way randomized open-label phase I clinical trial in healthy subjects. Br J Clin Pharmacol. 2017;83:2718–2728.
  • Almansa C, Mercè R, Tesson N, et al. Co-crystal of Tramadol Hydrochloride–celecoxib (ctc): a novel API–API co-crystal for the treatment of pain. Cryst Growth Des. 2017;17:1884–1892.
  • Issa MG, Ferraz HG. Intrinsic dissolution as a tool for evaluating drug solubility in accordance with the Biopharmaceutics Classification System. Dissolution Technol. 2011;18:6–13.
  • Videla S, Lahjou M, Vaque A, et al. Pharmacokinetics of multiple doses of Co-Crystal of Tramadol-Celecoxib: findings from a 4-way randomized open-label phase I clinical trial. Br J Clin Pharmacol. 2018;84:64–78.
  • Tallarida RJ. Drug synergism: its detection and applications. J Pharmacol Exp Ther. 2001;298:865–872.
  • Tallarida RJ. An overview of drug combination analysis with isobolograms. J Pharmacol Exp Ther. 2006;319:1–7.
  • Brennan TJ, Vandermeulen EP, Gebhart GF. Characterization of a rat model of incisional pain. Pain. 1996;64:493–501.
  • Gregory NS, Harris AL, Robinson CR, et al. An overview of animal models of pain: disease models and outcome measures. J Pain. 2013;14:1255–1269.
  • Whiteside GT, Harrison J, Boulet J, et al. Pharmacological characterisation of a rat model of incisional pain. Br J Pharmacol. 2004;141:85–91.
  • Merlos M, Portillo-Salido E, Brenchat A, et al. Administration of a co-crystal of tramadol and celecoxib in a 1:1 molecular ratio produces synergistic antinociceptive effects in a postoperative pain model in rats. Eur J Pharmacol. 2018;833:370–378.
  • Encina G, Encabo M, Escriche M, et al. The effect of food on tramadol and celecoxib bioavailability following oral administration of Co-Crystal of Tramadol-Celecoxib (CTC): A randomised, open-label, single dose, crossover study in healthy volunteers. Clin Drug Investig. 2018;38:819-827.
  • Dooner H, Mundin G, Mersmann S, et al. Pharmacokinetics of tramadol and celecoxib in Japanese and Caucasian subjects following administration of Co-Crystal of Tramadol-Celecoxib (CTC): a randomised, open-label study. Eur J Drug Metab Pharmacokinet. 2019;44:63-75.
  • Pfizer Ltd. Summary of product characteristics for Celebrex 100 mg capsule. 2018. [cited 2018 Apr 30]. Available from: http://www.medicines.org.uk/emc/medicine/14534.
  • Accord-UK Ltd. Summary of product characteristics for tramadol hydrochloride 50 mg capsules. 2017. [cited 2018 May 01]. Available from: http://www.medicines.org.uk/EMC/medicine/24186/SPC.
  • López-Cedrún J, Videla S, Burgueño M, et al. Co-crystal of Tramadol–celecoxib in patients with moderate to severe acute post-surgical oral pain: a dose-finding, randomised, double-blind, placebo- and active-controlled, multicentre, phase II trial. Drugs R D. 2018;18:137–148.
  • Barden J, Edwards JE, McQuay HJ, et al. Pain and analgesic response after third molar extraction and other postsurgical pain. Pain. 2004;107:86–90.
  • Dastros-Pitei D, Videla S, López-Cedrún JL, et al. CTC provides high analgesic efficacy in patients with severe baseline pain. Analgesic effects of Co-Crystal of Tramadol-Celecoxib in patients with moderate or severe pain at baseline: Subgroup analysis of a randomised, double-blind, phase II clinical trial in patients with acute pain after dental surgery. ESA 2017; Bucharest, Romania: Abstract 08AP01-7

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