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PubMed1998

Application of serum nicotine and plasma cotinine concentrations to assessment of nicotine replacement in light, moderate, and heavy smokers undergoing transdermal therapy.

As part of a clinical trial investigating the level of nicotine replacement with different doses of transdermal therapy for smoking cessation, peak and trough serum nicotine and plasma cotinine concentrations were measured in 70 subjects while they were actively smoking (baseline) and daily for 6 consecutive inpatient days while they were receiving transdermal nicotine. Subjects were randomly assigned to a daily 24-hour patch delivering a transdermal nicotine dose of 0, 11, 22, or 44 mg and stratified by self-reported smoking rate as either light (10-15 cigarettes per day), moderate (16-30 cigarettes per day), or heavy (>30 cigarettes per day). Steady-state concentrations of nicotine and cotinine were attained in 1 and 3 days, respectively, at all doses and were independent of baseline smoking rate. Mean percentage replacement of nicotine was calculated by dividing steady-state peak nicotine or cotinine concentrations by their respective baseline concentrations. Significant underreplacement occurred in subjects receiving the 11 mg/day patch regardless of baseline smoking rate. Underreplacement also occurred in moderate and heavy smokers receiving 22 mg/day and in light smokers at this same dose. Complete replacement occurred only in subjects receiving the 44 mg/day patch. These results have several implications for transdermal nicotine therapy. First, with the higher nicotine and cotinine levels observed with heavier smoking, it is inherent that one size does not fit all, and there is a need to consider more individualization of dosage for nicotine patch therapy. Second, there is substantial underreplacement with the 22 mg/day dose in moderate to heavy smokers and in some light smokers. Third, even with twice the usual dose (i.e., 44 mg/day), there was no accumulation of either nicotine or cotinine. Plasma cotinine levels after achievement of steady state (i.e., after 3 days of patch therapy) can be collected at any time and used to calculate percent replacement using baseline levels.

Administration, Cutaneous↗
PubMed2006

Transdermal buprenorphine in pain management--experiences from clinical practice: Five case studies.

Buprenorphine is a semi-synthetic opioid derived from thebaine. The transdermal formulation of buprenorphine has been available in Belgium for 3 years, during which time the Pain Clinic of the St Elisabeth of Verviers Hospital has gained experience in the use of transdermal buprenorphine for the treatment of moderate-to-severe pain. This paper presents four cases of chronic, non-malignant pain, and one case of chronic cancer pain. By starting patients on low doses and slowly titrating upwards, transdermal buprenorphine matrix patches provided effective analgesia and were well tolerated. Low doses of transdermal buprenorphine were created by cutting the smallest available matrix patch (35 mug/h) into halves or quarters. The initial dose was then gradually titrated upwards to the dose needed for optimum pain relief by the patients. No problems were encountered in switching patients from prior analgesic therapy with other opioids to transdermal buprenorphine.

Administration, Cutaneous↗
PubMed1994

Inhibition of platelet aggregation by transdermal glyceryl trinitrate.

OBJECTIVE: To determine the optimum conditions for the demonstration of an antiplatelet effect of nitric oxide and to use these conditions to elucidate the effects of a transdermal glyceryl trinitrate patch on platelet aggregation in normal volunteers. METHODS: An open prospective crossover study. The effects of nitric oxide on platelet aggregation in whole blood and platelet rich plasma as stimulated by adenosine diphosphate and U46619 was assessed in the presence and absence of iloprost and MB22948. Optimum conditions for the demonstration of an antiplatelet effect of nitric oxide were then applied to whole blood from normal volunteers in the presence and absence of a transdermal glyceryl trinitrate patch. SETTING: University hospital. SUBJECTS: Eight normal volunteers. MAIN OUTCOME MEASURES: Platelet aggregation in the presence and absence of transdermal glyceryl trinitrate. RESULTS: The optimum conditions for the demonstration of an antiplatelet effect of nitric oxide in whole blood were collecting blood into a tube containing MB22948 and citrate and stimulating platelet aggregation with adenosine diphosphate in the presence or absence of iloprost. Using this method a significant effect of transdermal glyceryl trinitrate on platelet aggregation was shown (P < 0.03) in the presence and absence of iloprost. CONCLUSIONS: These results are consistent with an inhibitory effect on platelet aggregation of nitric oxide liberated by transdermal glyceryl trinitrate. Optimum test conditions are needed to show this effect. The clinical significance of the antiplatelet effect of transdermal glyceryl trinitrate is unknown.

Adenosine Diphosphate↗
PubMed2004

Oral transmucosal abuse of transdermal fentanyl.

Transdermal fentanyl is an opioid analgesic that is effective on chronic pain, and which appears to be advantageous due to several factors such as ease of administration, the relatively stable serum concentration and long dose intervals. Nevertheless, the danger of abuse and dependence exists among patients who are prescribed fentanyl patches. We present a case of transdermal fentanyl abuse, where the administration route of the drug was changed. Our patient, who had no history of substance abuse and who suffered from chronic nonmalignant pain, used the fentanyl transdermal patches as oral transmucosal medication, raising the dose by ten-fold. This abuse of the drug was only for analgesic purposes without seeking anxiolysis and/or euphoria. After treatment and progressive reduction of fentanyl, the patient remains in good condition, and is currently taking the initial dose of the drug transdermally, without having experienced any withdrawal symptoms.

Administration, Cutaneous↗
PubMed1997

Transdermal nicotine replacement in pregnancy: maternal pharmacokinetics and fetal effects.

OBJECTIVE: Our purpose was to measure any short-term effects that the transdermal nicotine replacement system may have in pregnancy and to verify salivary nicotine and cotinine levels during patch placement. STUDY DESIGN: After customary smoking cessation efforts had failed, six prenatal patients between 28 and 37 weeks' gestation who smoked between one and two packs per day were enrolled in this prospective study. The patients were admitted to the General Clinical Research Center for a period of 21 hours. During hospitalization we performed maternal and fetal assessments including vital signs, biophysical profile and electronic fetal monitoring, amniotic fluid index, and umbilical artery Doppler examinations. Salivary samples for cotinine and nicotine levels were collected at standard intervals. RESULTS: There were no measurable differences in fetal or maternal well-being. During patch use salivary nicotine levels increased as expected, to a mean value of 19.0 +/- 13.5 micrograms/L at 480 minutes. Salivary cotinine concentrations remained low (approximately 50 micrograms/L) and varied little during the 480-minute period that the patch was worn. Overall, patients were satisfied with the transdermal patches. CONCLUSION: There were no adverse maternal or fetal effects from the transdermal nicotine replacement system over the 6-hour period. Salivary nicotine concentrations were consistent with those seen in nonpregnant adults. Surprisingly, salivary cotinine concentrations were much lower than those seen in smoking nonpregnant adults.

Administration, Cutaneous↗
PubMed1991

Skin pretreatment and the use of transdermal clonidine.

Although therapy with transdermal clonidine is effective in bringing elevated blood pressure under control, this mode of delivery has been associated with localized dermal reactions in a small percentage of patients. Because anecdotal information suggests that a number of physicians have resorted to various dermal pretreatment strategies in an effort to alleviate or eliminate these dermal reactions, we decided to investigate the two most commonly used pretreatment strategies, to determine if they affected the pharmacokinetics and pharmacodynamics of transdermally administered clonidine. Specifically, we examined the effect of dermal pretreatment with 0.5% hydrocortisone cream and with an over-the-counter antacid, magnesium-aluminum hydroxide suspension, on the pharmacokinetics of transdermal clonidine in 10 adult hypertensive males. Patients were randomized to receive one of the two pretreatment regimens or therapy with the patch alone, and after 7 days of treatment and a 14-day washout period, patients were crossed over to receive one of the other therapies. All patients ultimately received all three therapies. We present here the results from the 10 patients enrolled in our study. Our study found a statistical difference detected in maximum plasma concentration (Cmax), steady-state plasma concentration (Css), and apparent clonidine dose delivered (Doseapp) following dermal pretreatment with hydrocortisone compared with the transdermal patch alone. The mean +/- SD relative extents of absorption (Frel) of clonidine following dermal pretreatment with hydrocortisone and magnesium-aluminum hydroxide in respect to the transdermal patch alone were 94.84 +/- 45.69% and 97.65 +/- 59.65%, respectively. No significant difference was detected in this parameter. Supine and sitting blood pressures and pulse rates were similar during treatment with clonidine alone, following dermal pretreatment with hydrocortisone cream, and following pretreatment with magnesium-aluminum hydroxide suspension. In addition, systemic side effects were evenly distributed among treatments. However, dermal side effects were less frequent following pretreatment with hydrocortisone compared with magnesium-aluminum hydroxide and the patch alone. The results of this study suggest that dermal pretreatment with 0.5 percent hydrocortisone cream may significantly alter the plasma concentrations of transdermally administered clonidine without adversely altering the pharmacodynamics.

Administration, Cutaneous↗
PubMed2003

Transdermal delivery of sex steroids for hormone replacement therapy and contraception. A review of principles and practice.

The percutaneous route is an effective method for delivery of reproductive hormones. Several transdermal therapeutic systems (TTS) releasing estrogens, progestogens and androgens from patches attached to the skin are currently in clinical use. For women, transdermal systems have been developed for hormonal replacement therapy (HRT) and recently for contraception. HRT with patches releasing only estradiol (E2) should be supplemented with a progestogen to protect the endometrium. Patches simultaneously releasing both E2 and a progestogen are also available. Combined regimens are either continuous or sequential. In the latter, estrogen-only patches are applied for 14 days, followed by 14-day application of patches releasing both hormones. Transdermal HRT successfully treats menopausal symptoms and has a bone-sparing effect. Transdermal contraceptive patches deliver ethinyl E2 in combination with the progestogen norelgestromin. This system provides an effective contraceptive and acceptable bleeding pattern not different from that of oral contraceptives. The types of adverse events experienced are approximately the same as with oral contraceptives. Reactions at the application site cause about 3% women to discontinue the use of patches. Transdermal systems also have been designed to supplement testosterone in hypogonadal men. Testosterone released from patches produces positive effects on mood and sexual behavior and significantly increases bone mass. Men using testosterone patches have to be regularly monitored for an increase in prostate volume and changes in prostate-specific antigen. Reproductive steroids delivered by the skin avoid first-pass liver metabolism, typical of oral dosing; consequently, the liver tissue is affected to a lesser degree. Other advantages include rapid onset and termination of action, noninvasive self-administration and attainment of therapeutic hormone levels with low daily doses. Reduced frequency of dosing has the potential to improve patient compliance. While compliance is important for any hormone, it is particularly important for contraceptive purposes. Like oral delivery of sex steroids, percutaneous absorption is characterized by intra- and interindividual variability. New technologies under development, combining electronics and low-frequency ultrasound, have the potential to provide precise dosing as well as drug delivery "on demand."

Administration, Cutaneous↗
PubMed2004

Combined ethinylestradiol/gestodene contraceptive patch: two-center, open-label study of ovulation inhibition, acceptability and safety over two cycles in female volunteers.

OBJECTIVES: Determination of the ovulation inhibition efficacy of a new, transparent, transdermal, combined hormonal contraceptive patch (area 10 cm2) containing 0.9 mg ethinylestradiol and 1.9 mg gestodene in an open-label study of healthy, female volunteers (aged 18-35 years). METHODS: A total of 199 volunteers from two centers were requested to use the contraceptive patch (one patch/week for 3 weeks, followed by 1 week of no treatment), throughout two menstrual cycles. Ovarian activity was monitored by transvaginal ultrasonography and serum hormone determinations, and classified according to the Hoogland score. RESULTS: Ovulation inhibition was achieved in all participants (Hoogland score < 6). Secondary efficacy measures, including suppression of serum concentrations of estradiol and progesterone, and of the mid-cycle luteinizing hormone surge, confirmed ovulation inhibition. Ovulation returned in 85.7% of participants during the first cycle after cessation of treatment. There were no abnormal changes in safety parameters. A large majority of users rated the contraceptive patch as 'very convenient'. CONCLUSIONS: This study showed that the new, combined ethinylestradiol/gestodene contraceptive patch was highly effective in reversibly inhibiting ovulation, well tolerated and regarded as 'very convenient' by the majority of users. This new, transparent, transdermal matrix patch is an attractive alternative form of contraception.

Administration, Cutaneous↗
PubMed2003

Daily transdermal administration of selegiline to guinea-pigs preferentially inhibits monoamine oxidase activity in brain when compared with intestinal and hepatic tissues.

Selegiline has been formulated in an acrylic polymer adhesive mixture to be employed as a constant release topical patch for daily transdermal administration. Application of this selegiline transdermal system (STS) to guinea-pigs resulted in an average delivery of 1.185 mg selegiline/cm(2) patch/24 h. STS dose-response curves were generated by altering patch size (cm(2)). A transdermal dose range was identified which inhibited guinea-pig brain monoamine oxidase-B (MAO-B) by greater than 95% yet provided for a dose-dependent inhibition of monoamine oxidase-A (MAO-A) activity. The ID50 for inhibition of MAO-A activity in response to a 21-day daily regimen with transdermal selegiline was approximately 7.5-fold lower for cortical and striatal brain regions compared with that obtained for duodenum; hepatic MAO-A was unaffected following the same dosing regimen. By contrast, orally administered selegiline inhibited brain and duodenal MAO-A to the same extent, and generated a shallower dose-inhibition curve for brain MAO-A inhibition. In addition, transdermal delivery was approximately 6-8-times more potent than oral selegiline for the inhibition of brain MAO-A activity. It is concluded that daily transdermal selegiline administration may provide therapeutic advantages over oral treatment, based on its preferential, dose-dependent inhibition of brain vs peripheral MAO-A activity.

Administration, Cutaneous↗
PubMed1989

Intermittent transdermal nitroglycerin therapy in the treatment of chronic stable angina.

The effectiveness of an intermittent regimen of transdermal nitroglycerin in chronic stable angina was evaluated in 206 patients using serial treadmill testing. After a placebo stabilization phase, patients were randomized to 4 weeks of double-blind treatment with transdermal nitroglycerin, 10 or 20 cm2 (equivalent to 5 or 10 mg/24 h) (Group A); transdermal nitroglycerin, 30 or 40 cm2 (equivalent to 15 or 20 mg/24 h) (Group B), or placebo. Patches were applied at 8:00 AM and removed at 8:00 PM each day throughout the study. Treadmill testing was performed 0, 4, 8 and 12 h after patch application at baseline (day 0) and on days 1, 15 and 29. After short-term application of the transdermal patches, treadmill walking time was greater for patients in both Group A and Group B than for the placebo group at all time points tested; differences from placebo were statistically significant at 12 h for Group A and at 4, 8 and 12 h for Group B. After 2 and 4 weeks of long-term therapy, treadmill walking time was again greater for Group B than for the placebo group at all postapplication time points; differences from placebo reached statistical significance at 4 h (2 weeks) and 8 h (2 and 4 weeks). The improvement in the treadmill walking time seen over the short-term in Group A was largely lost after 4 weeks of long-term therapy. Potentially important differences in the patient characteristics of the two active treatment groups, particularly the greater use of a beta-adrenergic blocker among patients in Group A, may have contributed to these observed differences in treatment effect. An unexpected finding was the ability of the placebo group to exercise longer than either active treatment group just before patch application during long-term therapy; nonetheless, absolute responsiveness to transdermal nitroglycerin after patch application remained virtually unchanged in both active treatment groups during the 4 week treatment period. Intermittent transdermal nitroglycerin therapy was well tolerated in the vast majority of patients; nine patients experienced an increase in nonexertional angina during the patch-off periods but completed the study uneventfully.

Administration, Cutaneous↗
PubMed1984

Plasma nitroglycerin concentrations and hemodynamic effects of sublingual, ointment, and controlled-release forms of nitroglycerin.

After a sublingual test dose, 12 healthy men aged 21 to 29 yr were treated with controlled-release transdermal nitroglycerin skin patches designed to deliver 10 mg/day nitroglycerin and with nitroglycerin ointment (2%) (1-in amount from the tube spread over 50 cm2) for 24 hr in a double-blind crossover study. Assessment was by measurement of nitroglycerin in plasma, blood pressure, and pulse rate. The mean plasma concentration of nitroglycerin during ointment dosing was approximately 200% to 400% that during skin patch dosing. Levels during ointment dosing were closer to those from sublingual dosing than were those during skin patch dosing. Blood pressure and pulse rate changes were much the same during both transdermal treatments. Calculations showed that delivery of nitroglycerin from the skin patches would have to be over 40 to 80 cm2 of the skin to achieve nitroglycerin exposure of the order of that induced by 1 in of ointment spread over 50 cm2 or from sublingual dosing.

Administration, Oral↗
PubMed1995

Abnormal rheologic effects of glyceryl trinitrate in patients with non-insulin-dependent diabetes mellitus and reversal by antioxidants.

OBJECTIVE: To evaluate 1) the hemorrheologic and hemodynamic effects of glyceryl trinitrate in patients with non-insulin-dependent diabetes mellitus and 2) the influence of antioxidants on these effects. DESIGN: Case-control study. SETTING: University hospital clinic. PATIENTS: 40 patients with diabetes and no evidence of cardiovascular complications and 40 controls matched for demographic variables and body habitus. INTERVENTIONS: Sublingual glyceryl trinitrate (0.3 mg) and transdermal glyceryl trinitrate patches (10 mg/d). Vitamin E, 300 mg/d orally for 7 days, and glutathione, 600 mg intravenously or intramuscularly, were given to test the effects of antioxidant supplementation. MEASUREMENTS: Systolic, diastolic, and mean arterial pressure and heart rate; left ventricular ejection fraction; platelet aggregation, blood viscosity, and blood filterability in vitro and ex vivo. RESULTS: Compared with controls, patients with diabetes had increased platelet aggregation to adenosine diphosphate (P < 0.005), increased blood viscosity (P < 0.001), and decreased blood filterability (P = 0.041) at baseline; blood pressure, heart rate, and ejection fraction were similar in the two groups. In controls, both sublingual glyceryl trinitrate and transdermal glyceryl trinitrate patches significantly reduced platelet aggregation (-38%; 95% CI, -49% to -27%) and blood viscosity (-8%; CI, -11% to -5%) and increased blood filterability (10%; CI, 7.0% to 13.1%). Slight but significant decreases in blood pressure and ejection fraction and an increase in heart rate were also seen in controls after administration of glyceryl trinitrate (both preparations). In patients with diabetes, glyceryl trinitrate paradoxically increased platelet aggregation (24%; CI, 15% to 33%) and blood viscosity (6%; CI, 2.9% to 8.8%) and decreased blood filterability (-7%; CI, -9.5% to -4.4%); hemodynamic values did not change significantly. In both groups, rheologic responses to glyceryl trinitrate (end concentration, 100 and 200 ng/mL) in vitro were similar to those seen in ex vivo studies. Vitamin E and glutathione normalized rheologic responses to glyceryl trinitrate in patients with diabetes. CONCLUSIONS: Organic nitrates have beneficial effects on blood rheology in controls but not in patients with diabetes, in whom a paradoxical deterioration is seen. Antioxidant supplementation can normalize primary tolerance to the rheologic effects of nitrates in diabetes.

Adult↗
PubMed2002

Triclosan: release from transdermal adhesive formulations and in vitro permeation across human epidermal membranes.

Malarial resistance is an escalating global problem and consequently new and more efficacious treatments to combat malaria are urgently needed. The transdermal delivery of anti-malarials may provide an effective alternative or adjunct to conventional regimens. Triclosan is widely used as an anti-bacterial agent and it has recently been demonstrated that this compound has anti-malarial properties. Its high lipophilicity makes it a potential candidate for delivery across the skin and this paper examines in vitro the potential for the transdermal delivery of triclosan from 'drug-in-glue' formulations. Model patches were prepared using DuroTak 2287, 2516 and 2051 acrylic polymer adhesives loaded with 0, 30 and 50 mg per 0.785 cm(-2) triclosan and dissolution was measured over a 12-h period. There was no apparent difference between the adhesives at the 30 mg patch loading, but at 50 mg, the trend for increased release was 2051>2516>2287. No significant burst effect was apparent. Patches of 50 mg per 0.785 cm2 were then used to determine the permeation of triclosan across heat-separated human epidermal membranes in Franz diffusion cells, over a period of 48 h. The above general trend was reflected in the steady state flux values obtained: 2051:16.91 microg x cm(-2) x h(-1) (S.E.M. 1.29), 2516:15.05 microg x cm(-2) x h(-1) (S.E.M. 1.00), 2287 12.83 microg x cm(-2) x h(-1) (S.E.M. 2.81). Although pharmacokinetic data are not currently available to permit calculation of an efficacious patch size, the transdermal delivery of triclosan is feasible.

Adhesives↗
PubMed1994

Use of transdermal nicotine in a state-level prescription plan for the elderly. A first look at 'real-world' patch users.

OBJECTIVE: To assess transdermal nicotine use patterns and outcomes in a population of low-income older smokers. DESIGN: A 6-month telephone follow-up survey of smokers filling prescriptions for transdermal nicotine in the first 3 months of 1992. SETTING: Pennsylvania's Pharmaceutical Assistance Plan for the Elderly, the nation's largest state-level prescription plan for the elderly. POPULATION: A total of 1070 noninstitutionalized male and female smokers aged 65 through 74 years. MAIN OUTCOME MEASURES: Self-reported physician/pharmacist advice and adjunctive treatments, concomitant smoking, and 6-month smoking abstinence. RESULTS: Respondents were predominantly long-term heavy smokers. They used nicotine patches for an average of 5 weeks, with few reporting use beyond 3 months or recalling bothersome side effects. Most of those with previous quit attempts rated quitting with the patch "easier." The 29% self-reported 6-month quit rate observed is encouraging. However, compliance with patch use guidelines was far from ideal in this high-risk population: only 54% of respondents received any initial advice or materials from their physicians or pharmacists, fewer than 2% took part in a formal clinic or one-to-one treatment program, and almost half (47%) smoked while using the patch, including 20% who smoked every day. Concomitant smoking was strongly associated with failure to achieve abstinence (P < .001). More frequent contact with physicians and/or pharmacists was associated with less concomitant smoking (P < .001) and higher quit rates (P = .005). CONCLUSIONS: This survey offers an important first look at problems and prospects for nicotine patch therapy in older adults, with implications for other groups as well. Prospective studies are needed to clarify optimal treatment regimens and adjuncts.

Administration, Cutaneous↗
PubMed1984

Adverse dermatologic reaction to transdermal nitroglycerin.

The incidence of adverse effects from transdermal nitroglycerin systems is reported to be very low. A cutaneous reaction from Transderm-Nitro is described. The patient in this case was a 63-year-old male with a history of chronic obstructive lung disease, adult onset diabetes mellitus, peptic ulcer disease, congestive heart failure, and angina pectoris. Seven weeks after having used a Transderm-Nitro-5 patch daily, the patient was found to have two macular erythematous areas on his chest that corresponded to the exact sites of the nitroglycerin patch. Follow-up with the same patient, using a placebo Transderm-Nitro, elicited a reaction similar in appearance. The exact causative agent is unknown, but it is believed to be from the transdermal delivery system and not the nitroglycerin.

Dermatitis, Contact↗
PubMed1985

Effects of transdermal scopolamine upon psychological test performance at sea.

The effects of transdermal scopolamine upon objective psychological performance assessments and self reports of feeling states, were investigated with volunteer subjects at sea. Scopolamine and placebo patches were administered on consecutive days in a counterbalanced order. Psychological performance was assessed 24 h following each transdermal patch. Choice reaction time and code substitution performance levels were not significantly changed, but letter cancellation errors were significantly more frequent following transdermal scopolamine. Transdermal scopolamine caused significantly more reports of dry mouth. More subjects were also unable to undertake the performance tests following scopolamine than placebo, due to difficulties in focusing on the test materials. However despite deleterious side effects with some personnel, others responded positively to the scopolamine patch. As noted by other workers, responses to the transdermal scopolamine patch seem to be quite variable.

Adolescent↗