Pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxycodone transdermal patch system: a Phase I study.
| Autor: | Gavin PD; Phosphagenics Limited, 11 Duerdin Street, Clayton VIC 3168, Australia., Simon LS; SDG LLC, One Mifflin Place, Suite 400, Cambridge, MA 02138, USA., Schlagheck T; Analgesia, Inc. Research, Austin, TX 78735, USA., Smith AJ; Phosphagenics Limited, 11 Duerdin Street, Clayton VIC 3168, Australia., Shakib S; Royal Adelaide Hospital, University of Adelaide, Mail Delivery Point 22, North Terrace, 5000 Adelaide, Australia. |
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| Jazyk: | angličtina |
| Zdroj: | Pain management [Pain Manag] 2017 Jul; Vol. 7 (4), pp. 243-253. Date of Electronic Publication: 2017 Apr 19. |
| DOI: | 10.2217/pmt-2016-0068 |
| Abstrakt: | Aim: To characterize the pharmacokinetic profile and evaluate the safety and tolerability of a transdermal oxycodone patch containing tocopheryl phosphate mixture (TPM). Patients & Methods: Eleven healthy subjects received a single application of three TPM/oxycodone patches applied to the torso for 72 h. Results: Oxycodone was detected 8.0 ± 2.7-h postpatch administration, reaching a mean maximum plasma concentration of 3.41 ± 1.34 ng/ml at 49.3 ± 21.2 h. The safety profile was consistent with the application method and known side-effect profile of oxycodone and naltrexone. No treatment-limiting skin irritation was observed. Conclusion: A 3-day application of the TPM/oxycodone patch demonstrated an acceptable safety profile and was well tolerated by healthy subjects, with limited dermal irritation following application. |
| Databáze: | MEDLINE |
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