ABSTRACT
AIM: Characterize the pharmacokinetic profile and tolerability of two tocopheryl phosphate mixture/oxymorphone patch formulations in healthy subjects, and the active metabolite (6-OH-oxymorphone). MATERIALS & METHODS: Fifteen participants received a single application of oxymorphone patches +/- capsaicin for 72 h and were crossed-over for another 72 h. RESULTS: Plasma oxymorphone was detected approximately 7 h and 6-OH-oxymorphone after approximately 18-19 h postapplication of both formulations, respectively. For oxymorphone, median tmax was 24 h, and Cmax/Cmin ratio was approximately 2.4. The most frequently reported treatment-related adverse event was application site reaction, mainly with capsaicin formulation. CONCLUSION: Tocopheryl phosphate mixture/oxymorphone transdermal patches can successfully deliver therapeutic amounts of oxymorphone in a sustained manner over 72 h and are well tolerated. ANZCTR registration number: ACTRN12614000613606.
Subject(s)
Analgesics, Opioid/adverse effects , Analgesics, Opioid/pharmacokinetics , Oxymorphone/adverse effects , Oxymorphone/pharmacokinetics , alpha-Tocopherol/analogs & derivatives , Adult , Analgesics, Opioid/blood , Capsaicin/adverse effects , Capsaicin/pharmacokinetics , Cross-Over Studies , Drug Combinations , Humans , Male , Oxymorphone/blood , Pain Management/methods , Transdermal Patch , Young Adult , alpha-Tocopherol/adverse effects , alpha-Tocopherol/pharmacokineticsABSTRACT
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.
Subject(s)
Analgesics, Opioid , Oxycodone , Transdermal Patch , alpha-Tocopherol/analogs & derivatives , Adult , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/adverse effects , Analgesics, Opioid/pharmacokinetics , Drug Combinations , Female , Healthy Volunteers , Humans , Male , Oxycodone/administration & dosage , Oxycodone/adverse effects , Oxycodone/pharmacokinetics , Transdermal Patch/adverse effects , alpha-Tocopherol/administration & dosage , alpha-Tocopherol/adverse effects , alpha-Tocopherol/pharmacokineticsABSTRACT
A 64-year-old man with Waardenburg syndrome presented with anuria and was subsequently discovered by renal ultrasound to have unilateral renal agenesis. The patient is one of three generations with incidental finding of renal agenesis also marked by the presence of Waardenburg syndrome. To our knowledge, there has been no mention elsewhere in the scientific literature of a variant of Waardenburg syndrome with associated renal agenesis.
