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PubMed1989

Transdermal nitroglycerin in angina pectoris.

The transdermal nitroglycerin patches have been very successful nitrate formulations since their introduction in 1982. Nevertheless, considerable controversy regarding efficacy and tolerance has arisen. Nitroglycerin has multiple mechanisms of action in angina pectoris. Transdermal nitroglycerin in ointment formulation has been known to be effective in angina. The patches, when used in a dose of greater than or equal to 10 mg (24 h)-1, provide classic nitrate NTG effects in angina patients. However, the problem of nitrate tolerance is significant; in acute dosing, the transdermal patches lose their efficacy by 24 h and, with chronic dosing, appear usually to have little advantage over placebo in improvement of angina. An intermittent or interval approach to transdermal patch delivery appears to be the best method of avoiding nitrate tolerance. Current data suggest using the patches for 12 or 14 h consecutively and then removing them for 10-12 h. Such dosing strategies appear to eliminate or markedly reduce the problem of nitrate tolerance.

Administration, Cutaneous↗
PubMed1998

Factors influencing quality of life in cancer patients: the role of transdermal fentanyl in the management of pain.

A transdermal fentanyl patch for the treatment of chronic cancer-related pain is available in four dosages (25, 50, 75, and 100 microg/hr). Fentanyl is released from a 72-hour reservoir by diffusion through a controlled-release membrane to the skin, through which it is absorbed into the microcirculation. The pharmacokinetics of fentanyl differ markedly as a function of the route of administration. Unlike intravenous administration, in which peak plasma levels occur within minutes and the plasma elimination half-life is 2 to 3 hours, after initial transdermal fentanyl patch application, peak levels occur within 14 hours and the elimination half-life exceeds 24 hours. When compared with oral morphine at doses effecting the same degree of pain relief, fewer gastrointestinal disturbances (nausea, vomiting, and constipation) and better alertness and sleep quality have been reported in two studies. The transdermal fentanyl patch is as effective as oral opioids in relieving cancer-related pain, with a safety and side effect profile equal to or better than that of oral opioids. The convenient, once-every-72 hours dosing regimen is easily adjusted to the individual's need for around-the-clock pain control, and provides stable and predictable therapeutic drug plasma concentrations. Patient acceptability is high and the cost is lower than other methods required to deliver parenteral opioids. The recent development of an oral transmucosal fentanyl citrate delivery system for the treatment of breakthrough pain will further expand the use of transdermal fentanyl patches for the treatment of chronic pain.

Administration, Cutaneous↗
PubMed2005

[Effect of penetration enhancers on the transdermal penetration of sinomenine liposome patch].

OBJECTIVE: To study the effect of penetration enhancers on the transdermal penetration of sinomenine liposome patch. METHODS: We firstly established the experimental method of transdermal penetration, and the methodology study was carried out at the same time. Furthermore, we added 5% Azone, 10% Oleic acid, 1% PG + 4% Azone, 2% PG + 8% Oleic acid into the patch. The cumulative penetration amounts were determined during the test of transdermal penetration and the part lagged in the skin was determined after the test. RESULTS: The cumulative penetration amounts released from the patch increased, while the part lagged in the skin decreased at the same time. CONCLUSIONS: The results indicate that penetration enhancers can facilitate drug through corneum into dermis, but can't enhance the drug' s accumulation in the corneum. It is concluded that penetration enhancers can destroy the two-molecule structure of liposomes and cause drug leakage, so penetration enhancers should not be added into liposome patch of part functions.

Administration, Cutaneous↗
PubMed1996

Effectiveness of nicotine patches in a workplace smoking cessation program. An eleven-month follow-up study.

Transdermal nicotine patches are widely prescribed as part of smoking cessation programs, but their efficacy beyond 6 months is not well established. We evaluated the efficacy of a 70-day treatment regimen among 75 subjects in an industrial setting where follow-up was conducted for 11 months. The median time free of cigarettes was 73 days, and the overall smoking abstinence rate was 9% after 11 months of follow-up. Smoking abstinence was significantly higher among those subjects who completed the full course of treatment than among those who did not (25 vs 6%, respectively). Smoking abstinence was also higher among subjects who started smoking after age 17 than among those who started at younger ages and was higher among male than female subjects. We conclude that transdermal nicotine patches are of limited efficacy in achieving long-term smoking cessation and that the relative costs and benefits of this treatment are not adequately specified.

Administration, Cutaneous↗
PubMed2000

Improved patient acceptability with a transdermal drug-in-adhesive oestradiol patch.

The aim of this trial was to assess the relative patient acceptability of two transdermal oestradiol patches used in treatment of oestrogen deficiency in postmenopausal women. Thirty-five hysterectomised postmenopausal women with no previous experience of transdermal oestradiol delivery systems received treatment with either once-weekly drug-in-adhesive (DIA) patches or twice-weekly reservoir patches for 4 weeks, and were then switched to the alternative treatment for a further 4 weeks. At the end of the study, the patients completed a questionnaire to assess their relative preference for a number of characteristics of the 2 transdermal systems and, where possible, their preference for transdermal compared with oral hormone replacement therapy. Thirty-one patients completed the study; four withdrew during treatment with the reservoir patch. The DIA patch was preferred for being 'easiest to remember to apply' by 80% of patients (p < 0.01), 'easiest to open' and 'easiest to apply' by 68% (p = 0.025), and as having 'best cosmetic appearance' by 65% (p = 0.05) and 'best overall skin adhesion' by 61% (p < 0.01). While 10% of patients rated the reservoir patch as 'least irritating to the skin' (p = 0.03), only one patient found this patch 'most comfortable to wear' (p < 0.01). The DIA patch was selected by 87% of patients as their preferred treatment overall (p = 0.001). Ninety-one per cent of 22 responding patients were at least as confident of treatment with transdermal patches as with oral hormone replacement therapy (p = 0.006) and 74 % of 27 responders preferred transdermal to oral treatment (p = 0.004). The DIA patch appears to be more acceptable to patients than the reservoir patch as a transdermal oestradiol delivery system for the treatment of postmenopausal oestrogen deficiency. Characteristics of the DIA patch which may account for improved patient acceptance include ease of remembering once-weekly patch application, improved cosmetic appearance and comfort, and better adhesion.

Administration, Cutaneous↗
PubMed1995

The effects of ethanol on the clearance of estradiol in postmenopausal women.

OBJECTIVE: To determine whether acute alcohol ingestion affects the pattern of decline of circulating E2 levels after removal of transdermal E2 patches. DESIGN: A randomized, placebo-controlled, crossover study. SETTING: The study was performed in the Clinical Research Center of the Brigham and Women's Hospital. PARTICIPANTS: Twelve healthy postmenopausal women were enrolled. INTERVENTIONS: Transdermal E2 patches, 0.15 mg, were applied 13 hours before subjects ingested alcohol (1 mL/kg 95% ethanol) or carbohydrate placebo punch. The patches were removed immediately after drink ingestion. MAIN OUTCOME MEASURES: Estradiol, estrone (E1), and ethanol levels were measured. RESULTS: Serum samples were obtained for 40 minutes before drink ingestion and 5 hours after drink ingestion and E2 patch removal. At the time of patch removal, E2 levels rose acutely over 10 minutes and then decreased rapidly, suggesting a bolus effect that was more marked after ethanol ingestion. After ethanol ingestion and patch removal the half-life of E2 was calculated to be 378 minutes, and after carbohydrate punch and patch removal 245 minutes. There were no significant changes in E1 concentrations over the time course of the study between groups. CONCLUSIONS: Ethanol ingestion may decrease E2 clearance after removal of transdermal E2 patches.

Administration, Cutaneous↗
PubMed2006

A review of transdermal hormonal contraception : focus on the ethinylestradiol/norelgestromin contraceptive patch.

Imperfect use of contraceptive methods notably increases the likelihood of pregnancy. One means of improving user adherence with hormonal contraception is to minimize the dosing schedule. Two forms of hormonal contraceptive have currently achieved this goal: the transdermal patch and the vaginal ring. The first and only transdermal contraceptive patch to receive worldwide regulatory approval (ethinylestradiol/norelgestromin) is a convenient approach to contraception that has a similar efficacy to oral contraceptives (OCs), but with the benefit of once-weekly administration. In addition, transdermal delivery of contraceptive hormones eliminates variability in gastrointestinal absorption, avoids hepatic first-pass metabolism, and prevents the peaks and troughs in serum concentrations that are seen with OCs. Norelgestromin, the progestin contained in the patch, is the active metabolite of norgestimate and is structurally related to 19-nortestosterone. Norgestimate and norelgestromin mimic the physiologic effects of progesterone at the progesterone receptor; however, norelgestromin has negligible direct or indirect androgenic activity, suggesting that it may be suitable for women with disorders related to androgen excess (such as hirsutism, acne, and lipid disorders).Contraceptive effectiveness is usually a function of the efficacy of a contraceptive in combination with compliance with its dosing regimen. The efficacy of the contraceptive patch has been clearly demonstrated in three phase III trials, two of which were randomized comparisons with an OC. The likelihood of pregnancy was similar between these contraceptive methods; however, compliance with the patch was notably better, particularly in younger women. The safety and tolerability profile of the patch was similar to that of the OC. A cost-effectiveness analysis has suggested that the contraceptive patch is more cost effective than the OC, due to decreased costs related to unwanted pregnancy.

Contraception↗
PubMed1991

Pharmacodynamic effects of transdermal bupranolol and timolol in vivo: comparison of microemulsions and matrix patches as vehicle.

Transdermal administration of drugs possesses several advantages in therapy, but is limited by generally poor penetration through the skin. The aim of this study was to assess whether in vivo transdermal absorption could be enhanced by using microemulsions (ME) as vehicles. Water uptake from the occluded skin changes the water-free microemulsion base (MEB) into a ME. The increasing content of water decreases the solubility of apolar drugs. This leads to in situ formation of a super-saturated ME that possesses a particularly high absorption rate due to the enhanced diffusion pressure of the drug. A saturated solution of the model drugs bupranolol (B) and timolol (T) in a water-free microemulsion base was applied to an clipped area of the dorsal skin of rabbits with an occlusive patch. Evaluations were made in comparison to matrix patches (M) containing 1.2 mg/cm2 B or 2.0 mg/cm2 T. The beta-blocker dose applied was 2.0 mg/kg body weight throughout the study. The measured parameter of the pharmacodynamic effect was the maximal heart rate (HR) after an i.v. bolus injection of a standard dose of isoproterenol. Observations were made in different intervals over a 10-h time period after application of the patches. The response to isoproterenol was calculated as beta-blocker effect. Faster increasing effects and higher maxima for both drugs was found after application in MEB compared to M. After administration of B and T in MEB the effects were found to be identical, with a maximum (85-90%) after 2 h. Application in M showed B to be less effective (34%, 10h no plateau) than T (74%, 10h). Therefore microemulsions represent an improved vehicle for transdermal administration of test drugs.

Administration, Cutaneous↗
PubMed1989

Treatment of severe premenstrual syndrome with oestradiol patches and cyclical oral norethisterone.

40 patients with premenstrual symptoms were randomly allocated to receive placebo patches or active treatment with transdermal oestradiol patches (2 x 100 micrograms) to suppress ovulation. Norethisterone 5 mg was given in each group from day 19-26 of the cycle to ensure a regular withdrawal bleed. Treatment was for 6 months with crossover at 3 months. Patients completed the Moos menstrual distress questionnaire (MDQ) and the premenstrual distress questionnaire (PDQ) daily throughout the study. 5 patients withdrew, 4 because of skin reactions and 1 because of considerable improvement with initial (active) treatment. After 3 months, both groups showed improvement in MDQ and PDQ scores. In general, between 3 and 6 months, patients who switched from active treatment to placebo had deteriorating scores while patients who switched from placebo to active treatment maintained or improved upon their initial gains. Significant improvements occurred after changing to active treatment in five of six negative MDQ symptom clusters and in six of ten PDQ symptoms.

Administration, Cutaneous↗
PubMedDate not supplied

[Effects of transdermal nicotine as an adjunct in smoking cessation therapy. A double-blind randomized study controlled with placebo].

To assess the smoking cessation efficacy of transdermal nicotine patches an adjunct to low-intervention therapy, we conducted a double-blind, placebo-controlled trial in 158 smokers. Participants were randomly assigned to one of the following three study regimens that required daily application of two 15-cm2 patches: 1) 24-hour nicotine delivery, 2) nicotine delivery during wakeful hours only, and 3) placebo. The impact of the three regimens on smoking cessation rates and tobacco withdrawal symptoms was examined. During the last 2 weeks of the trial, 39% of the 24-hour nicotine regimen delivery group, 35% of those on wakeful hour nicotine regimens, and 13.5% of the placebo treatment group achieved abstinence. Self-reported quit rates for the two nicotine patch-wearing regimens, as compared with that for the placebo group, continued to be significantly higher at 6 months. Moreover, compared with placebo, the transdermal nicotine patches significantly reduced tobacco withdrawal symptoms during the first few weeks of quitting. The differences in quit rates and tobacco withdrawal symptoms between the to active groups were not statistically significant. The patches were well tolerated both topically and systemically. We concluded that transdermal nicotine, when used as an adjunct to low-intervention therapy, significantly reduced tobacco withdrawal symptoms and enhanced smoking cessation rates.

Administration, Cutaneous↗
PubMed1991

Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy. A randomized, placebo-controlled, double-blind study.

To assess the smoking cessation efficacy of transdermal nicotine patches as an adjunct to low-intervention therapy, we conducted a double-blind, placebo-controlled trial in 158 smokers. Participants were randomly assigned to one of the following three study regimens that required daily application of two 15-cm2 patches: (1) 24-hour nicotine delivery, (2) nicotine delivery during wakeful hours only, and (3) placebo. The impact of the three regimens on smoking cessation rates and tobacco withdrawal symptoms was examined. During the last 2 weeks of the trial, 39% of the 24-hour nicotine regimen delivery group, 35% of those on wakeful hour nicotine regimens, and 13.5% of the placebo treatment group achieved abstinence. Self-reported quit rates for the two nicotine patch-wearing regimens, as compared with that for the placebo group, continued to be significantly higher at 6 months. Moreover, compared with placebo, the transdermal nicotine patches significantly reduced tobacco withdrawal symptoms during the first few weeks of quitting. The differences in quit rates and tobacco withdrawal symptoms between the two active groups were not statistically significant. The patches were well tolerated both topically and systemically. We concluded that transdermal nicotine, when used as an adjunct to low-intervention therapy, significantly reduced tobacco withdrawal symptoms and enhanced smoking cessation rates.

Administration, Cutaneous↗
PubMed2005

Transdermal buprenorphine in the treatment of chronic pain.

The transdermal matrix patch formulation of buprenorphine has been shown to be effective in managing moderate-to-severe cancer pain and severe pain unresponsive to nonopioid analgesics. Clinical trials have revealed that it is possible to switch from weak opioids or low doses of step III opioids to transdermal buprenorphine without any problems. With buprenorphine patches, the sublingual buprenorphine intake was dose-dependently reduced and was superior to placebo in this respect. The proportion of responders increased with the buprenorphine dose, and a higher proportion of patients receiving buprenorphine patches reported uninterrupted sleep for longer than 6 h compared with those receiving placebo. In a long-term, open, follow-up study in which the mean duration of treatment was 7.5 months, analgesia was rated as at least satisfactory by 90% of patients. Almost 60% of patients could manage their pain with one patch alone or with one additional sublingual tablet a day during the whole period of treatment, indicating a low incidence of tolerance development. The buprenorphine transdermal patch was assessed as user friendly by 94.6% of patients. In a postmarketing surveillance study, pain relief with transdermal buprenorphine was rated as good or very good by 70% of the responders. Postmarketing surveillance studies have shown that transdermal buprenorphine is also effective in the management of nociceptive and neuropathic pain, which some studies have shown to be relatively insensitive to mu-opioid analgesics, such as morphine. Transdermal buprenorphine was well tolerated. Most adverse events were either local reactions to the patch that generally subsided within 24 h or systemic events typical of treatment with opioid analgesics, such as nausea, vomiting and constipation.

Administration, Cutaneous↗
PubMed1997

Patterns of use of a free nicotine patch program for Medicaid and uninsured patients.

This study assessed the use and effectiveness of a free nicotine patch program among Medicaid and uninsured smokers. Patterns of patch use, associated behaviors with quit attempt, side effects, and self-reported abstinence from smoking for 6 months were evaluated prospectively among patients from five urban family practice offices and a nicotine dependence clinic located in a comprehensive cancer center in Western New York. Results indicated that the majority of participants used the program as intended, and 90% of the participants found the patch useful in their quit attempt. Fourteen percent of participants were abstinent for 6 months or more. We found no support for inappropriate use of transdermal nicotine patches among patients with no health insurance or those on Medicaid. Transdermal nicotine patches are an effective cessation aid for smokers. Given the tall of the consequences of smoking on health costs, barriers to access to effective treatment for smoking cessation among individuals covered by Medicaid for health insurance need to be eliminated.

Administration, Cutaneous↗
PubMed2004

[Restlessness in intensive care unit: think to the nicotinic withdrawal syndrome].

We report a case of tobacco-addicted woman who has been hospitalized in intensive care unit. During mechanical ventilation, management of sedation was difficult, when she was awake, we observed restlessness associated with failure of the mechanical ventilation weaning. The improvement of restlessness and mechanical ventilation were obtained when we set a transdermal nicotine patch. This observation suggests that the nicotine withdrawal syndrome is an unrecognized cause of restlessness and that the transdermal nicotine patch should be a diagnosis means which is safe, cheap and easy to use.

Administration, Cutaneous↗
PubMed1997

Plasma levels of nicotine and safety of smokers wearing transdermal delivery systems during multiple simultaneous intake of nicotine and during exercise.

Although transdermal nicotine patches have been studied extensively under recommended conditions, the present studies were designed to assess the nicotine plasma levels and the safety of transdermal nicotine patches in smokers undergoing situations suspected to result in increased nicotine plasma levels. The first study examined the effects of increasing nicotine intake through sequential administration of a nicotine patch (day 2), a patch followed by consumption of nicotine gum (day 3), and a patch followed by gum consumption and cigarette smoking (day 4). In this study, nicotine plasma levels increased transiently after the addition of each nicotine source. Mean areas under the concentration-time curves from 0 to 24 hours (AUC0-24) for nicotine were 453 +/- 120 ng.hr/mL (day 2), 489 +/- 143 ng.hr/mL (day 3), and 485 +/- 143 ng.hr/mL (day 4). The second study evaluated the effects of physical exercise on the kinetics and the safety of two different types of nicotine transdermal devices: Nicoderm and Habitrol. The mean delivered dose of nicotine was higher with Nicoderm compared with Habitrol, and the two products were not considered to be bioequivalent. During a 20-minute exercise period, nicotine plasma levels increased by 13 +/- 9% for Nicoderm and 30 +/- 20% for Habitrol. This increase in nicotine plasma levels was probably related to the exercise-induced increase in peripheral circulation at the patch site. Results from both studies indicate a clinically nonsignificant increase in blood pressure and heart rate after the administration of nicotine. After exercise, subjects taking Habitrol tended to have a higher incidence of adverse events compared with baseline values. Safety profiles remained acceptable in both studies despite the increases in nicotine plasma levels. It was concluded that both superimposed nicotine sources and physical exertion result in short-lived plasma nicotine elevations and temporarily increase nicotine pharmacodynamic parameters without increased risk to the volunteers.

Administration, Cutaneous↗
PubMed2003

The pharmacokinetics of transdermal fentanyl delivered with and without controlled heat.

Preliminary reports have demonstrated that the application of local heat to the transdermal fentanyl patch significantly increased systemic delivery of fentanyl. The objective of this study was to further evaluate the pharmacokinetic effect of local heat administration on fentanyl drug delivery through the transdermal fentanyl patch delivery system in volunteers. In addition, the study was intended to document the effect of heat on steady-state transdermal fentanyl delivery. This was an open, 3-period, crossover study that evaluated the pharmacokinetics and safety of 25 microg/h transdermal fentanyl administered with and without local heat. During Sessions A and B, subjects received transdermal fentanyl for a 30-hour period. During Session A, heat was applied for 1 hour at the 24-hour time point during the 30-hour period. During Session B, heat was applied for the first 4 hours and then again for 1 hour at the 24-hour time point during the 30-hour period. The order of Sessions A and B was randomized, and a minimum of 2 weeks separated the sessions. Five of the 10 subjects returned to participate in Session C. During Session C, subjects received transdermal fentanyl 25 microg/h for 18 hours. Heat was applied during the first 4 hours of administration and then again for 15-minute periods at the 12- and 16-hour time points. Arterial blood samples for determination of serum fentanyl concentration were collected. Maximum concentration (C(max)), time to maximum concentration (t(max)), and area under the curve (AUC) were determined for each treatment period. Sedation, vital signs, oxygen saturation, and adverse events were recorded. During a period of 36 hours, there were no significant differences in C(max), AUC, or T(max) between transdermal fentanyl delivery with no heat and heat. However, significant differences were seen during the first 4 hours, with C(max) and AUC values almost 3 times higher for the heated administrations than for the administrations without heat. With heat, the mean C(max) was 0.63 ng/mL compared with a C(max) of 0.24 ng/mL without heat (P =.007). With early heat, the mean AUC was 1.22 ng/mL. h compared with 0.42 ng/mL. h without heat (P =.003). There was no statistically significant difference between the median times to achieve peak values (T(max)) during the first 4 hours. The addition of heat at 24 hours resulted in rapid increases in serum fentanyl concentrations for both groups and higher serum fentanyl concentrations for the administration that did not receive heat previously. Applying heat for 15 minutes at the 12-hour and 16-hour time points produced a rapid but short duration increase in serum fentanyl concentrations. The results suggest controlled heat might be used to significantly shorten the time needed to reach clinically important fentanyl concentrations. Controlled heat might be useful to produce rapid increases in serum concentrations for the rapid treatment of breakthrough pain.

Administration, Cutaneous↗
PubMed1998

Half-life of estradiol in postmenopausal women.

Estrogen replacement is often advised for postmenopausal women to prevent menopausal symptoms, osteoporosis and heart disease. However, little information is available concerning the half-life of estradiol (E2) in postmenopausal women. This study was designed to determine the half-life and metabolism of transdermal E2. A prospective clinical study of 8 healthy postmenopausal women was performed in the Clinical Research Center of the Brigham and Women's Hospital. A transdermal E2 patch 0.10 mg was placed on the abdominal wall. Thirteen hours later, after an overnight fast, the E2 patch was removed and frequent blood sampling was performed over 6 h. Serum samples were assayed for E2, estrone (E1) and estrone sulfate (E1S). Serum samples were taken before E2 patch placement, for 30 min before patch removal, and for 6 h after patch removal. The basal E2 level of women prior to use of transdermal E2 was 19 +/- 2 pg/ml (mean +/- SE). Thirteen hours after transdermal E2 placement, steady state levels had been reached, with a mean E2 of 112 +/- 6 pg/ml. The mean half-life of E2 after removal of transdermal E2 was 161 min (range 107-221 min). There was a direct relationship between the subjects' weight and the half-life of E2 (r = 0.79, p = 0.02). Mean basal E1 levels were 23 +/- 5 pg/ml and mean E1 steady-state levels after E2 patch placement were 39 +/- 0.6 pg/ml. E1S levels rose from mean basal levels of 1.5 +/- 0.3 ng/ml to mean steady-state levels of 3.1 +/- 0.1 ng/ml after placement of the E2 patch. The apparent half-life of E2 after discontinuing a transdermal E2 patch is 2.7 h or 161 min.

Administration, Cutaneous↗