메뉴 건너뛰기




Volumn 75, Issue 2, 2010, Pages 225-231

Transdermal fentanyl matrix patches Matrifen® and Durogesic® DTrans® are bioequivalent

Author keywords

Bioequivalence; Durogesic DTrans ; Fentanyl; Healthy subjects; Matrifen ; Opioid; Pain; Pharmacokinetics; Phase I; Safety

Indexed keywords

DTRANS; FENTANYL; MATRIFEN; UNCLASSIFIED DRUG;

EID: 77952922454     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2010.02.005     Document Type: Article
Times cited : (16)

References (22)
  • 1
    • 0031018574 scopus 로고    scopus 로고
    • Transdermal fentanyl. A review of its pharmacological properties and therapeutic efficacy in pain control
    • Jeal W., Benfield P. Transdermal fentanyl. A review of its pharmacological properties and therapeutic efficacy in pain control. Drugs 1997, 53:109-138.
    • (1997) Drugs , vol.53 , pp. 109-138
    • Jeal, W.1    Benfield, P.2
  • 2
    • 5444238662 scopus 로고    scopus 로고
    • Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain
    • Clark A.J., Ahmedzai S.H., Allan L.G., Camacho F., Horbay G.L., Richarz U., Simpson K. Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain. Curr. Med Res. Opin. 2004, 20:1419-1428.
    • (2004) Curr. Med Res. Opin. , vol.20 , pp. 1419-1428
    • Clark, A.J.1    Ahmedzai, S.H.2    Allan, L.G.3    Camacho, F.4    Horbay, G.L.5    Richarz, U.6    Simpson, K.7
  • 5
    • 0030909704 scopus 로고    scopus 로고
    • Transdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy, and quality of life. The TTS-fentanyl comparative trial group
    • Ahmedzai S., Brooks D. Transdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy, and quality of life. The TTS-fentanyl comparative trial group. J. Pain Symptom. Manage. 1997, 13:254-261.
    • (1997) J. Pain Symptom. Manage. , vol.13 , pp. 254-261
    • Ahmedzai, S.1    Brooks, D.2
  • 6
    • 1242269248 scopus 로고    scopus 로고
    • Incidence of constipation associated with long-acting opioid therapy: a comparative study
    • Staats P.S., Markowitz J., Schein J. Incidence of constipation associated with long-acting opioid therapy: a comparative study. South. Med. J. 2004, 97:129-134.
    • (2004) South. Med. J. , vol.97 , pp. 129-134
    • Staats, P.S.1    Markowitz, J.2    Schein, J.3
  • 7
    • 41149155227 scopus 로고    scopus 로고
    • Adverse effects of transdermal opiates treating moderate-severe cancer pain in comparison to long-acting morphine: a meta-analysis and systematic review of the literature
    • Tassinari D., Sartori S., Tamburini E., Scarpi E., Raffaeli W., Tombesi P., Maltoni M. Adverse effects of transdermal opiates treating moderate-severe cancer pain in comparison to long-acting morphine: a meta-analysis and systematic review of the literature. J. Palliative Med. 2008, 11:492-501.
    • (2008) J. Palliative Med. , vol.11 , pp. 492-501
    • Tassinari, D.1    Sartori, S.2    Tamburini, E.3    Scarpi, E.4    Raffaeli, W.5    Tombesi, P.6    Maltoni, M.7
  • 8
    • 56549092721 scopus 로고    scopus 로고
    • Control of pain in adults with cancer: summary of SIGN guidelines
    • Cormie P.J., Nairn M., Welsh J. Control of pain in adults with cancer: summary of SIGN guidelines. BMJ 2008, 337:a2154.
    • (2008) BMJ , vol.337
    • Cormie, P.J.1    Nairn, M.2    Welsh, J.3
  • 9
    • 7044245703 scopus 로고    scopus 로고
    • Opioids in renal failure and dialysis patients
    • Dean M. Opioids in renal failure and dialysis patients. J. Pain Symptom. Manage. 2004, 28:497-504.
    • (2004) J. Pain Symptom. Manage. , vol.28 , pp. 497-504
    • Dean, M.1
  • 10
    • 0142186036 scopus 로고    scopus 로고
    • Benefit-risk assessment of transdermal fentanyl for the treatment of chronic pain
    • Kornick C.A., Santiago-Palma J., Moryl N., Payne R., Obbens E.A. Benefit-risk assessment of transdermal fentanyl for the treatment of chronic pain. Drug Safety 2003, 26:951-973.
    • (2003) Drug Safety , vol.26 , pp. 951-973
    • Kornick, C.A.1    Santiago-Palma, J.2    Moryl, N.3    Payne, R.4    Obbens, E.A.5
  • 11
    • 77952895755 scopus 로고    scopus 로고
    • FDA. Information for healthcare professionals fentanyl transdermal system (marketed as Duragesic® and generics). US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER),. <> (accessed 17.07.09).
    • FDA. Information for healthcare professionals fentanyl transdermal system (marketed as Duragesic® and generics). US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2007. <> (accessed 17.07.09). http://www.ovha.vermont.gov/for-providers/i2a_fda_gov_cder_drug_infosheets_hcp_fentanyl_2007hcp.pdf.
    • (2007)
  • 12
    • 51449109808 scopus 로고    scopus 로고
    • Transdermal matrix fentanyl membrane patch (matrifen): in severe cancer-related chronic pain
    • Hair P.I., Keating G.M., McKeage K. Transdermal matrix fentanyl membrane patch (matrifen): in severe cancer-related chronic pain. Drugs 2008, 68:2001-2009.
    • (2008) Drugs , vol.68 , pp. 2001-2009
    • Hair, P.I.1    Keating, G.M.2    McKeage, K.3
  • 13
    • 49149123466 scopus 로고    scopus 로고
    • Fentanyl transdermal matrix patch (Durotep MT patch; Durogesic DTrans; Durogesic SMAT): in adults with cancer-related pain
    • Hoy S.M., Keating G.M. Fentanyl transdermal matrix patch (Durotep MT patch; Durogesic DTrans; Durogesic SMAT): in adults with cancer-related pain. Drugs 2008, 68:1711-1721.
    • (2008) Drugs , vol.68 , pp. 1711-1721
    • Hoy, S.M.1    Keating, G.M.2
  • 14
    • 77952919490 scopus 로고    scopus 로고
    • Janssen-Cilag Ltd. Durogesic® DTrans Transdermal Patch. Summary of product characteristics, (accessed 17.07.09).
    • Janssen-Cilag Ltd. Durogesic® DTrans Transdermal Patch. Summary of product characteristics, 2008. (accessed 17.07.09). http://www.medicines.ie/document.aspx?documentid=10566.
    • (2008)
  • 15
    • 77952906347 scopus 로고    scopus 로고
    • Nycomed. Matrifen® Transdermal patch. Summary of product characteristics,. (accessed 17.07.09).
    • Nycomed. Matrifen® Transdermal patch. Summary of product characteristics, 2008. (accessed 17.07.09). http://www.medicines.ie/medicine/12189/SPC/Matrifen+Transdermal+patch/.
    • (2008)
  • 16
    • 33745278000 scopus 로고    scopus 로고
    • Pharmacokinetics, tolerability, and performance of a novel matrix transdermal delivery system of fentanyl relative to the commercially available reservoir formulation in healthy subjects
    • Marier J.F., Lor M., Potvin D., Dimarco M., Morelli G., Saedder E.A. Pharmacokinetics, tolerability, and performance of a novel matrix transdermal delivery system of fentanyl relative to the commercially available reservoir formulation in healthy subjects. J. Clin. Pharmacol. 2006, 46:642-653.
    • (2006) J. Clin. Pharmacol. , vol.46 , pp. 642-653
    • Marier, J.F.1    Lor, M.2    Potvin, D.3    Dimarco, M.4    Morelli, G.5    Saedder, E.A.6
  • 17
    • 33845412248 scopus 로고    scopus 로고
    • Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation
    • Marier J.F., Lor M., Morin J., Roux L., Di Marco M., Morelli G., Saedder E.A. Comparative bioequivalence study between a novel matrix transdermal delivery system of fentanyl and a commercially available reservoir formulation. Brit. J. Clin. Pharmacol. 2007, 63:121-124.
    • (2007) Brit. J. Clin. Pharmacol. , vol.63 , pp. 121-124
    • Marier, J.F.1    Lor, M.2    Morin, J.3    Roux, L.4    Di Marco, M.5    Morelli, G.6    Saedder, E.A.7
  • 18
    • 29144442167 scopus 로고    scopus 로고
    • Evaluation of the bioequivalence of two transdermal fentanyl systems following single and repeat applications
    • Sathyan G., Guo C., Sivakumar K., Gidwani S., Gupta S. Evaluation of the bioequivalence of two transdermal fentanyl systems following single and repeat applications. Curr. Med. Res. Opin. 2005, 21:1961-1968.
    • (2005) Curr. Med. Res. Opin. , vol.21 , pp. 1961-1968
    • Sathyan, G.1    Guo, C.2    Sivakumar, K.3    Gidwani, S.4    Gupta, S.5
  • 19
    • 0032991187 scopus 로고    scopus 로고
    • Development and validation of an HPLC assay for fentanyl and related substances in fentanyl citrate injection, USP
    • Lambropoulos J., Spanos G.A., Lazaridis N.V., Ingallinera T.S., Rodriguez V.K. Development and validation of an HPLC assay for fentanyl and related substances in fentanyl citrate injection, USP. J. Pharm. Biomed. Anal. 1999, 20:705-716.
    • (1999) J. Pharm. Biomed. Anal. , vol.20 , pp. 705-716
    • Lambropoulos, J.1    Spanos, G.A.2    Lazaridis, N.V.3    Ingallinera, T.S.4    Rodriguez, V.K.5
  • 20
    • 77952896042 scopus 로고    scopus 로고
    • FDA. Draft guidance on Lidocaine (Patch/Topical). US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER),. (accessed 17.12.09).
    • FDA. Draft guidance on Lidocaine (Patch/Topical). US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2006. (accessed 17.12.09). http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm086293.pdf.
    • (2006)
  • 21
    • 77952950265 scopus 로고    scopus 로고
    • FDA. Guidance for industry. Statistical approaches to establishing bioequivalence. US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER),. (accessed 17.07.09).
    • FDA. Guidance for industry. Statistical approaches to establishing bioequivalence. US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2001. (accessed 17.07.09). http://www.fda.gov/cder/guidance/index.htm.
    • (2001)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.