Pharmacokinetics, Safety and Tolerability of a Novel Tocopheryl Phosphate Mixture/Oxycodone Transdermal Patch System: A Phase I Study

References

• Chou R , FanciulloGJ , FinePGet al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain . J. Pain10 ( 2 ), 113 – 130 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Fields HL . The doctor’s dilemma: opiate analgesics and chronic pain . Neuron69 ( 4 ), 591 – 594 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Smith HS . Opioid metabolism . Mayo Clin. Proc.84 ( 7 ), 613 – 624 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Berland D , RodgersP . Rational use of opioids for management of chronic nonterminal pain . Am. Fam. Physician86 ( 3 ), 252 – 258 ( 2012 ).
   PubMed Web of Science ®Google Scholar
• Moradi M , EsmaeiliS , ShoarS , SafariS . Use of oxycodone in pain management . Anesth. Pain Med.1 ( 4 ), 262 – 264 ( 2012 ).
   PubMedGoogle Scholar
• Mandala M , MoroC , LabiancaR , CremonesiM , BarniS . Optimizing use of opiates in the management of cancer pain . Ther. Clin. Risk Manag.2 ( 4 ), 447 – 453 ( 2006 ).
   PubMedGoogle Scholar
• Leow KP , SmithMT , WilliamsB , CramondT . Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer . Clin. Pharmcol. Ther.52 ( 5 ), 487 – 495 ( 1992 ).
   PubMed Web of Science ®Google Scholar
• Pöyhiä R , SeppalaT , OlkkolaKT , KalsoE . The pharmacokinetics and metabolism of oxycodone after intramuscular and oral administration to healthy subjects . Br. J. Clin. Pharmacol.33 ( 6 ), 617 – 621 ( 1992 ).
   PubMed Web of Science ®Google Scholar
• Hoskin PJ , HanksGW , AherneGW , ChapmanD , LittletonP , FilshieJ . The bioavailability and pharmacokinetics of morphine after intravenous, oral and buccal administration in healthy volunteers . Br. J. Clin. Pharmacol.27 ( 4 ), 499 – 505 ( 1989 ).
   PubMed Web of Science ®Google Scholar
• Osborne R , JoelS , TrewD , SlevinM . Morphine and metabolite behavior after different routes of morphine administration: demonstration of the importance of the active metabolite morphine-6-glucuronide . Clin. Pharmacol. Ther.47 ( 1 ), 12 – 19 ( 1990 ).
   PubMed Web of Science ®Google Scholar
• Kim JY , LeeSH , ParkCWet al. Design and in vivo evaluation of oxycodone once-a-day controlled-release tablets . Drug Des. Devel. Ther.9 , 695 – 706 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Li Y , SunD , PalmisanoM , ZhouS . Slow drug delivery decreased total body clearance and altered bioavailability of immediate- and controlled-release oxycodone formulations . Pharmacol. Res. Perspect.4 ( 1 ), e00210 ( 2016 ).
   PubMedGoogle Scholar
• Olesen AE , StaahlC , Arendt-NielsenL , DrewesAM . Different effects of morphine and oxycodone in experimentally evoked hyperalgesia: a human translational study . Br. J. Clin. Pharmacol.70 ( 2 ), 189 – 200 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Hamunen K , PaakkariP , KalsoE . Trends in opioid consumption in the Nordic countries 2002–2006 . Eur. J. Pain13 ( 9 ), 954 – 962 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Kalso E . Oxycodone . J. Pain Symptom Manage.29 ( Suppl. 5 ), S47 – S56 ( 2005 ).
   PubMed Web of Science ®Google Scholar
• Schmidt-Hansen M , BennettMI , ArnoldS , BromhamN , HilgartJS . Oxycodone for cancer-related pain . Cochrane Database Syst. Rev.27 ( 2 ), CD003870 ( 2015 ).
   Google Scholar
• Riley J , EisenbergE , Muller-SchwefeG , DrewesAM , Arendt-NielsenL . Oxycodone: a review of its use in the management of pain . Curr. Med. Res. Opin.24 ( 1 ), 175 – 192 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Ordonez Gallego A , Gonzalez BaronM , Espinosa ArranzE . Oxycodone: a pharmacological and clinical review . Clin. Transl. Oncol.9 ( 5 ), 298 – 307 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Sehgal N , SmithHS , ManchikantiL . Peripherally acting opioids and clinical implications for pain control . Pain Physician14 ( 3 ), 249 – 258 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Coluzzi F , MattiaC . Chronic non-cancer pain: focus on once-daily tramadol formulations . Ther. Clin. Risk Manag.3 ( 5 ), 819 – 829 ( 2007 ).
   PubMedGoogle Scholar
• Czarnecki ML , JandrisevitsMD , TheilerSC , HuthMM , WeismanSJ . Controlled-release oxycodone for the management of pediatric postoperative pain . J. Pain Symptom Manage.27 ( 4 ), 379 – 386 ( 2004 ).
   PubMed Web of Science ®Google Scholar
• Coluzzi F , MattiaC . OROS(R) hydromorphone in chronic pain management: when drug delivery technology matches clinical needs . Minerva Anestesiol.76 ( 12 ), 1072 – 1084 ( 2010 ).
   PubMed Web of Science ®Google Scholar
• Moorman-Li R , MotyckaCA , IngeLD , CongdonJM , HobsonS , PokropskiB . A review of abuse-deterrent opioids for chronic nonmalignant pain . P. T.37 ( 7 ), 412 – 418 ( 2012 ).
   PubMedGoogle Scholar
• Tassinari D , DrudiF , RosatiM , MaltoniM . Transdermal opioids as front line treatment of moderate to severe cancer pain: a systemic review . Palliat. Med.25 ( 5 ), 478 – 487 ( 2011 ).
   PubMed Web of Science ®Google Scholar
• Skaer TL . Transdermal opioids for cancer pain . Health Qual. Life Outcomes4 , 24 ( 2006 ).
   PubMed Web of Science ®Google Scholar
• Margetts L , SawyerR . Transdermal drug delivery: principles and opioid therapy . Continuing Education in Anaesthesia, Critical Care Pain7 ( 5 ), 171 – 176 ( 2007 ).
   Google Scholar
• Kuo A , WyseBD , MeutermansW , SmithMT . In vivo profiling of seven common opioids for antinociception, constipation and respiratory depression: no two opioids have the same profile . Br. J. Pharmacol.172 ( 2 ), 532 – 548 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Schmelz M , PausR . Opioids and the skin: ‘itchy’ perspectives beyond analgesia and abuse . J. Invest. Dermatol.127 ( 6 ), 1287 – 1289 ( 2007 ).
   PubMed Web of Science ®Google Scholar
• Gavin PD , El-TamimyM , KeahHH , BoydBJ . Tocopheryl phosphate mixture (TPM) as a novel lipid-based transdermal drug delivery carrier: formulation and evaluation . Drug Deliv. Transl. Res.7 ( 1 ), 53 – 65 ( 2016 ).
   Web of Science ®Google Scholar
• Gavin P , GriffeyA , GianelloRet al. Transdermal delivery of various molecules in vivo using alpha-tocopheryl phosphate . Drug Deliv. Tech.8 ( 9 ), 34 – 41 ( 2008 ).
   Google Scholar
• Ohmori Y . Protective effect of sodium dl-alpha-tocopheryl phosphate for UV-induced skin damage . J. Cosmet. Sci. Soc.30 ( 1 ), 18 – 22 ( 2006 ).
   Google Scholar
• Trescot AM , DattaS , LeeM , HansenH . Opioid pharmacology . Pain Physician11 ( Suppl. 2 ), S133 – S153 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Peng PW , SandlerAN . A review of the use of fentanyl analgesia in the management of acute pain in adults . Anesthesiology90 ( 2 ), 576 – 599 ( 1999 ).
   PubMed Web of Science ®Google Scholar
• Electronic Medicines Compendium, Napp Pharmaceuticals Ltd . OxyContin 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg and 120 mg prolonged release tablets . Summary of Product Characteristics ( Updated August 2016 ). www.medicines.org.uk/emc/medicine/29384 .
   Google Scholar
• Paudel KS , MilewskiM , SwadleyCL , BrogdenNK , GhoshP , StinchcombAL . Challenges and opportunities in dermal/transdermal delivery . Ther. Deliv.1 ( 1 ), 109 – 131 ( 2010 ).
   PubMedGoogle Scholar
• Smith MT , WyseBD , EdwardsSR , El-TamimyM , GaetanoG , GavinP . Topical application of a novel oxycodone gel formulation (tocopheryl phosphate mixture) in a rat model of peripheral inflammatory pain produces localized pain relief without significant systemic exposure . J. Pharm. Sci.104 ( 7 ), 2388 – 2396 ( 2015 ).
   PubMed Web of Science ®Google Scholar
• Smith HS . Peripherally-acting opioids . Pain Physician11 ( Suppl. 2 ), S121 – 132 ( 2008 ).
   PubMed Web of Science ®Google Scholar
• Ghelardini C , Di Cesare MannelliL , BianchiE . The pharmacological basis of opioids . Clin. Cases Miner. Bone Metab.12 ( 3 ), 219 – 221 ( 2015 ).
   PubMedGoogle Scholar
• Barber A , GottschlichR . Opioid agonists and antagonists: an evaluation of their peripheral actions in inflammation . Med. Res. Rev.12 ( 5 ), 525 – 562 ( 1992 ).
   PubMed Web of Science ®Google Scholar
• Stein C . The control of pain in peripheral tissue by opioids . N. Engl. J. Med.332 ( 25 ), 1685 – 1690 ( 1995 ).
   PubMed Web of Science ®Google Scholar
• Stein C . Targeting pain and inflammation by peripherally acting opioids . Front. Pharmacol.4 , 123 ( 2013 ).
   PubMed Web of Science ®Google Scholar
• Stein C , SchaferM , MachelskaH . Attacking pain at its source: new perspectives on opioids . Nat. Med.9 ( 8 ), 1003 – 1008 ( 2003 ).
   PubMed Web of Science ®Google Scholar
• Sampathkumar P , DrageLA , MartinDP . Herpes zoster (shingles) and postherpetic neuralgia . Mayo Clin. Proc.84 ( 3 ), 274 – 280 ( 2009 ).
   PubMed Web of Science ®Google Scholar
• Hahn KL . Strategies to prevent opioid misuse, abuse, and diversion that may also reduce the associated costs . Am. Health Drug Benefits4 ( 2 ), 107 – 114 ( 2011 ).
   PubMedGoogle Scholar