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PubMedDate not supplied

High-dose fentanyl patch for cancer pain.

OBJECTIVE: To describe a successful experience with a high dose (1000 microg/hr) of transdermal fentanyl for cancer pain relief. CASE REPORT: A 62-year-old man suffering from rectal carcinoma was treated by our home care hospice unit during his last 3.5 months of life. At admission to our home care unit, he suffered mostly from severe anal pain (verbal pain scale of 10/10) due to advanced disease. He was then on 150 microg/hr transdermal fentanyl. Adjuvant therapy with amitriptyline 50 mg/day and dexamethasone 4 mg/day was added, but it did not relieve his pain. The dose of transdermal fentanyl was increased gradually to 1000 microg/hr with good pain control (verbal pain scale of 1 to 4/10 most of the time). Before his death, he was mentally alert with good pain control. CONCLUSIONS: High doses of transdermal fentanyl (1000 microg/hr; 10 patches) should be considered for pain relief in cancer patients.

Administration, Cutaneous↗
PubMed1990

Transdermal nitroglycerin (glyceryl trinitrate). A review of its pharmacology and therapeutic use.

Nitroglycerin (glyceryl trinitrate) has been used for many years via the sublingual route for treating acute anginal attacks. In recent years transdermal delivery of nitroglycerin has gained popularity for prophylaxis against angina. However, nitrate tolerance appears to be a therapeutic problem with all long-acting nitrates regardless of delivery mechanism, and it occurs in most patients with stable angina treated with continuous 24-hour application of nitroglycerin patches. Since continuous 24-hour plasma concentrations of nitroglycerin do not appear to be desirable, alternative approaches to therapy are needed. A simple method to minimise tolerance with transdermal nitroglycerin patches is to remove the patch at bedtime and reapply a new patch in the morning. Such intermittent therapy allows a patch-free period during the night, when most patients experience few angina attacks, but optimises nitrate sensitivity during the daytime. However, the place of intermittent nitroglycerin patch therapy in the treatment of stable angina needs clarification with further study, particularly comparisons with other long-acting forms of nitrates. There are insufficient data to recommend the use of transdermal nitroglycerin patches in the treatment of patients with unstable angina or congestive heart failure. In conclusion, transdermal nitroglycerin patches offer a convenient and cosmetically acceptable dosage form which has potential use in stable angina if administered as an intermittent regimen providing a patch-free period each night.

Administration, Cutaneous↗
PubMed2006

A comparison of the skin irritation potential of transdermal fentanyl versus transdermal buprenorphine in middle-aged to elderly healthy volunteers.

OBJECTIVE: Establishing local tolerability of transdermal opioid systems is important as more systems become available for use in a range of indications. We compared the skin irritation potential of a single application of transdermal fentanyl (Durogesic D-trans; DDTDF) and transdermal buprenorphine (Transtec; TDB) patches in healthy volunteers. METHODS: 46 healthy males and females (mean age [range]: 59.6 [50-69] years) with healthy skin received a single dose of both the DDTDF 25 mug/h patch and the TDB 35 mug/h patch in a randomised order under naltrexone cover. The incidence and severity of erythema was assessed at various timepoints after patch removal. RESULTS: There was a non-significant trend towards a higher incidence of erythema 60 min after patch removal with TDB compared with DDTDF. The severity of erythema at 60 min and the incidence of erythema at 72 h after patch removal were significantly higher with TDB than with DDTDF (p = 0.01 and 22% versus 4.9%, p = 0.04, respectively). In general, the results from the chromametric assessment of treated skin were in agreement. The incidence of topical adverse events (AEs) was lower with DDTDF than with TDB (one versus six events) and subjects preferred the DDTDF patch and felt it was less noticeable on the skin. The DDTDF patch was considered less painful to remove, and, consistent with that, the TDB patch was judged to have better adhesion. Twenty-one subjects reported systemic AEs with DDTDF plus naltrexone and 22 with TDB plus naltrexone, most of which were considered treatment-related, 34 and 60 AEs, respectively. CONCLUSIONS: Local tolerability of transdermal opioid systems should be considered when making a therapeutic choice. Even after a single application in healthy volunteers, differences in local tolerability, assessed both clinically and by chromametry, and patch comfort were shown between DDTDF and TDB, in favour of DDTDF.

Administration, Cutaneous↗
PubMed2005

The effect of transdermal delivery of fentanyl on activity in growing pigs.

Recently, decreased activity levels have been observed in pigs treated postoperatively with transdermal delivery of fentanyl (TD-fentanyl) after isoflurane anaesthesia. Whether the change in behaviour is related to opioid-induced sedation or to insufficient pain relief remains to be investigated. This study was therefore undertaken to evaluate the effect of TD-fentanyl 50 microg h(-1) on the activity level with and without isoflurane anaesthesia. Eight pigs (25.4 +/- 5.2 kg) were submitted to a cross-over study and given two treatments; 1) fentanyl patch applied after 30 minutes of anaesthesia (treatment A/F) and 2) fentanyl patch without anaesthesia (treatment F). The pigs' behaviour was observed from a video recording instantaneously every 10 minutes for 24 h before treatments and up to 72 h after the patch attachment. Venous blood samples were taken 1, 6, 12, 24, 48 and 72 h after the patch application. The behaviour recordings showed that TD-fentanyl did not produce sedation in any pig. No differences were found between the two treatments in activity level, weight gain or serum fentanyl concentration. This concentration measured after 24 h was 0.27 +/- 0.11 ng ml(-1) and 0.47 +/- 0.40 ng ml(-1) in the A/F and F group, respectively. In conclusion, transdermal delivery of 50 microg h(-1) fentanyl did not cause inactivity in growing pigs. However, the large variations in serum fentanyl concentration indicate that drug absorption from transdermal patches is unpredictable and sometimes deficient.

Administration, Cutaneous↗
PubMed1997

Relationship between amount of beta-blockers permeating through the stratum corneum and skin irritation after application of beta-blocker adhesive patches to guinea pig skin.

We evaluated the relationship between the cumulative amounts of 5 kinds of beta-blockers (alprenolol, oxprenolol, timolol, acebutolol and atenolol) permeating through the stratum corneum and a* values obtained by measuring the formation of erythema, a skin irritation reaction, with a chromameter after transdermal application of adhesive patches containing 2 beta-blocker to the skin of guinea pigs. The cumulative amount of beta-blocker released from each adhesive patch to the skin increased with the increase in application time. The contents of alprenolol, oxprenolol and timolol in the stratum corneum and in the stripped skin increased markedly up to 4 h after application and thereafter were maintained at high levels up to 24 h. The contents of acebutolol and atenolol, on the other hand, increased up to 24 h, but these values were low. a* values of all adhesive patches 24 h after application were higher than those before application. The correlation coefficients between the cumulative amounts of alprenolol, oxprenolol, timolol, acebutolol or atenolol permeating through the stratum corneum and (delta a* -delta a*Placebo) values were 0.739, 0.717, 0.722, 0.551 and 0.633, respectively. The correlation coefficient calculated by averaging the cumulative amounts of 6 kinds of beta-blockers permeating through the stratum corneum [including propranolol which was reported previously (Kobayashi I., et al., Biol. Pharm. Bull., 19, 839-844 (1996))] was 0.731, higher than the correlation coefficient between contents of these beta-blockers in the stripped skin and (delta a* -delta a*Placebo) values (r = 0.552). This suggests that there was a high correlation between the cumulative amounts of beta-blockers permeating through the stratum corneum and (delta a* -delta a*Placebo) values.

Acebutolol↗
PubMed1997

Transdermal nitroglycerin: clinical and pharmacokinetic consequences of renewing the patch and the application site.

OBJECTIVE: We examined whether nitroglycerin (glyceryl trinitrate, GTN) patch treatment for 24 h could induce local cutaneous changes that impaired drug delivery and clinical efficacy. METHODS: Twenty angina patients were exercise-tested after 2 and 24 h of treatment and then 2 h after patch renewal. The patch was either renewed on a new skin location or on the previous application site in a randomised, double-blind, cross-over protocol. GTN plasma concentrations and finger plethysmography were obtained before and after each exercise test. RESULTS AND CONCLUSIONS: The clinical efficacy, the effect seen on plethysmography and the GTN plasma concentrations tended to increase after patch renewal, regardless of the application site of the renewed patch. Hence, cutaneous changes of clinical importance could not be demonstrated.

Administration, Cutaneous↗
PubMed1999

Use of X-ray crystallography for the characterization of single crystals grown in steroid containing transdermal drug delivery systems.

Target of the study was to characterize crystals which had grown in steroid-containing matrix patches during short-term storage and to thereby establish a rationale for the inhibition of crystal formation in those patches in general. Matrix type transdermal drug delivery systems (TDDS) containing either 2.2% gestodene or 3.3% estradiol were free of crystals directly after their production. However, crystals of up to 800 microns in length grew during 3 months of storage at ambient temperature. The application of several analytical methods did not help to identify the crystals. This was mainly due to the fact that the adhesive matrix surrounding the crystals could not be fully removed in the course of sample preparation with routine laboratory methods and thus impaired DSC, FTIR microscopy and hot stage polarized microscopy. However, within X-ray diffractometry, the residual amorphous patch matrix did not hamper the measurement of the crystals. Thus, they were identified as estradiol hemihydrate and gestodene form I, respectively. These results suggest that steroid-containing matrix TDDS should be stabilized against drug recrystallization e.g. by the addition of suitable crystallization inhibitors. Furthermore, systems containing estradiol may be stabilized by efficient removal water.

Administration, Cutaneous↗
PubMedDate not supplied

Continuous hormone replacement therapy for menopause combining nomegestrol acetate and gel, patch, or oral estrogen: a comparison of amenorrhea rates.

This open-label, prospective, randomized, multicenter trial compared the incidence of amenorrhea in 54 postmenopausal women (mean age, 54.9 +/- 0.6 years) who underwent six 4-week cycles of continuous hormone replacement therapy combining a progestin-nomegestrol acetate 2.5 mg/d--plus one of three estrogens: percutaneous 17beta-estradiol gel (1.5 mg/d, group A), transdermal 17beta-estradiol patch (50 microg/d, group B), or oral estradiol valerate (2 mg/d, group C). Based on an intent-to-treat analysis, the rate of amenorrhea varied significantly according to which estrogen preparation was used. Calculated cycle by cycle, rates of amenorrhea were 67% to 83% for group A, 25% to 56% for group B, and 53% to 61% for group C. Overall rates of persistent amenorrhea were not statistically different between groups for cycles 1 through 3, but for cycles 4 through 6, significantly more women in groups A and C (67% and 46%, respectively) experienced amenorrhea than did those in group B (12%). Amenorrhea rates for the entire six-cycle period were 78% for group A, 48% for group B, and 60% for group C. These differences were not statistically significant. The differences in rates could not be attributed to endometrial atrophy, since when measured by transvaginal sonography, endometrial thickness did not differ significantly between groups. Of the original population, 7% withdrew prematurely because of bleeding. The data for all three groups confirmed that in two out of three women, the occurrence of amenorrhea during the first three cycles predicted continuation of amenorrhea during subsequent cycles and that for 51% of women, < or =10 days of bleeding during the first three cycles predicted amenorrhea during the last three cycles. Calculated as a function of the number of women included in the trial, the percentage of amenorrheic women (evaluated cycle by cycle or for the second three-cycle period) was highest when the progestin was combined with percutaneous 17beta-estradiol gel, although findings were similar with estradiol valerate. The percutaneous 17beta-estradiol gel was also associated with a higher percentage of amenorrheal cycles than was estradiol valerate or transdermal estrogen, although differences were significant only in comparison with the transdermal formulation. This difference may have positive clinical implications.

Amenorrhea↗
PubMed1995

[Smoking cessation with the nicotine patch].

Smoking cessation programs have become much more effective since the transdermal nicotine delivery system is available. Nicotine patches are well tolerated, have little side-effect and reduce the withdrawal symptoms of nicotine abstinence. Short- and long-term abstinence rates increase when nicotine patches are combined with behavioral therapy. This paper reports current scientific literature on placebo-controlled trials and gives treatment advices for smoking cessation using nicotine patches by general practitioners. Although nicotine patches are now available in Germany without prescription, therapeutic support by physicians, pharmacists or psychologists is indispensable for successful smoking cessation.

Administration, Cutaneous↗
PubMed1996

Short-term estradiol treatment enhances pituitary-adrenal axis and sympathetic responses to psychosocial stress in healthy young men.

Evidence from animal studies and clinical observations suggest that the activity of the pituitary-adrenal axis is under significant influence of sex steroids. The present study investigated how a short term elevation of estradiol levels affects ACTH, cortisol, norepinephrine, and heart rate responses to mental stress in healthy men. In a double blind study, 16 men received a patch delivering 0.1 mg estradiol/day transdermally, and age- and body mass index-matched control subjects received a placebo patch. Twenty-four to 48 h later, they were exposed to a brief psychosocial stressor (free speech and mental arithmetic in front of an audience). In response to the psychosocial stressor, ACTH, cortisol, norepinephrine, and heart rate were increased in both experimental groups (all P < 0.0001). However, the estradiol-treated subjects showed exaggerated peak ACTH (P < 0.001) and cortisol (P < 0.002) responses compared to the placebo group. Also, the norepinephrine area under the response curve was greater in the estradiol group (P < 0.05). Although heart rate responses differences failed to reach statistical significance, they, too, tended to be larger in the estradiol group. Neither mood ratings before or after the stressor, nor ratings of the perception of the stressor could explain the observed endocrine response differences. In conclusion, short term estradiol administration resulted in hyperresponses of the pituitary-adrenal axis and norepinephrine to psychosocial stress in healthy young men independent of psychological effects, as assessed in this study.

Adrenal Glands↗
PubMed1989

New indices in the evaluation of clonidine transdermal therapy of hypertension.

Since high blood pressure might be more harmful the higher it is and the more it remains above a determined critical value (140/90 mm Hg - 18.7/12.0 k Pa - in the present study), the hyperbaric impact, a measure of the total load exerted on the arterial walls and the total time during the day when blood pressure is elevated above the critical value, have been evaluated. Ten patients with essential hypertension underwent non-invasive automatic 24-h blood pressure monitoring three times (baseline and after three and seven days from the application on the upper chest of a transdermal self-adhesive patch delivering clonidine). The recorder was programmed to measure blood pressure every 30 min during the day and every 60 min during the night. Significantly lower values of blood pressure, hyperbaric impact and duration of elevated blood pressure have been demonstrated from the third day after the beginning of transdermal therapy.

Administration, Cutaneous↗
PubMed1995

Postoperative pain control with a new transdermal fentanyl delivery system. A multicenter trial.

BACKGROUND: A new transdermal delivery system for fentanyl is available in two strengths: 70-80 and 90-100 micrograms.kg-1.h-1 (40- and 60-cm2 patches, respectively). Their short onset and 24-h drug delivery make them attractive for postoperative pain control. METHODS: Both doses of the new transdermal fentanyl patches were evaluated for the relief of postoperative pain in 143 patients after gynecologic exploratory laparotomy. The study was conducted at four centers using a prospective, randomized, placebo-controlled, double-blind format. Patients were randomly assigned to one of three study groups: group 1 patients received two placebo patches: group 2 patients received a 40-cm2 fentanyl patch and a 60-cm2 placebo patch; and group 3 patients received a 60-cm2 fentanyl patch and a 40-cm2 placebo patch. Patient-controlled morphine use and pain, sedation, and comfort scores were assessed postoperatively every 4 h for 36 h after patch placement. RESULTS: Patients' assessment of their analgesia was significantly (P < or = 0.05) better in group 2 at 16 and 24 h and in group 3 at 8, 12, 16, 20, and 24 h postoperatively, compared with the patients in group 1. Patients in groups 2 and 3 required less supplemental morphine to maintain satisfactory analgesia than did the patients in group 1. Patients in groups 2 and 3 had greater incidences of pruritus, erythema, and respiratory depression than did those receiving placebo. CONCLUSIONS: Concern exists regarding the side effects of this this new transdermal fentanyl patch. Therefore, this new patch will need further research before it can be recommended as an adjunct in controlling postoperative pain.

Administration, Cutaneous↗
PubMedDate not supplied

A randomized study to compare the effectiveness, tolerability, and acceptability of two different transdermal estradiol replacement therapies. The Transdermal HRT Investigators Group.

This randomized trial was designed to assess the efficacy, tolerability, and acceptability of two different transdermal estradiol replacement therapies: Cilag Estradiol-TTS (a matrix system) and Ciba-Geigy Estradiol-TTS (a reservoir system). Five hundred and fourteen patients were evaluable for efficacy, and all patients who had received the study medications were evaluated for safety (n = 530). Both treatments significantly improved systemic and urogenital symptoms as evidenced by a decrease in the number of hot flushes and the Kupperman Index score; there was no difference in effectiveness between the two treatments. Safety evaluation revealed a low incidence of adverse events, mainly compatible with exogenously administered estrogen and progestagen. Endometrial biopsies at the end of treatment were similar between groups and consistent with balanced hormone replacement therapy. Analyses of acceptability data revealed a low incidence of skin reactions and an added benefit with the Cilag-Estradiol-TTS patch in terms of convenience owing to the adhesiveness of the patch. In conclusion, both transdermal estradiol replacement therapies were effective and well tolerated in the treatment of postmenopausal estrogen deficiency symptoms, and the Cilag Estradiol-TTS patch had an advantage in terms of convenience and adhesiveness.

Administration, Cutaneous↗
PubMed1999

Future drug delivery research in South Korea.

According to the Science Citation Index database, over 50 papers related to drug delivery have been published from South Korea during the last 3 years. For the purpose of this presentation, some of the recently carried out research in our department will be introduced and future research directions presented. Proliposomes are free flowing particles which are composed of drugs, phospholipids and a water soluble porous powder, and immediately form a liposomal dispersion upon hydration. The preparation can be stored sterilized in a dried state and, by controlling the size of the porous powder in proliposomes, relatively narrow range of reconstituted liposome size can be obtained. Because of these properties, proliposomes appear to be a potential alternative to liposomes in design and fabrication of liposomal dosage forms. Thus, we tested the feasibility of this preparation as a sustained transdermal dosage form. Proliposomes containing varying amount of nicotine, a model drug, were prepared using sorbitol and lecithin. Microscopic observation revealed that this preparation is converted to liposomes almost completely within minutes following contact with water. The release pattern of the model drug from this preparation was apparently similar to that of the Exodus((R)) patch, a commercially available transdermal nicotine formulation. Compared with nicotine powder, the nicotine flux across rat skin from proliposomes was initially retarded, and appeared to remain constant. This observation indicated that sustained transdermal delivery of nicotine is feasible using proliposomal formulations under occluded condition. In addition to the investigation of the potential application of proliposomes, we were also interested in the role of the stratum corneum (SC) in the enhanced delivery of drugs from liposomes. Thus, liposome-gel formulation containing hydrocortisone (HC), a model hydrophobic drug, was prepared and used in this study. The study was carried out on both normal and stratum corneum removed skins. Percutaneous absorption of HC across SC removed skin was significantly faster than that across normal skin, suggesting that SC behaves as a penetration barrier for the liposome-bound drugs. Interestingly, the liposome-gel in this study reduced the skin absorption of HC, compared with the conventional ointment formulation. The amount of HC absorbed from the liposome-gel after 8 h into the SC-removed skin was less than one third of that from the conventional ointment. Despite the reduced absorption, a higher and sustained skin concentrations of HC were achieved for the liposome-gel. Drug concentration in both viable and deep skin reached a maximum within 0.5 h. However, drug concentrations in these tissues declined as a function of time for conventional ointment, while those from the liposome-gel were greatly sustained, resulting in a 5-fold higher viable skin drug level was obtained at 8 h after the application. In contrast, plasma concentration of HC at 4 h from the liposome-gel was only one-fourth the value from the conventional ointment in the SC-removed skin. Therefore, the higher and sustained drug concentration in the viable skin appeared not to be due to the enhanced percutaneous absorption but due to retarded diffusion of the drug from the skin.

Animals↗
PubMed1998

Changes in plasma and urinary norepinephrine following transdermal clonidine in spontaneously hypertensive rats.

To support a long-lasting antihypertensive effect of transdermal clonidine (CAS 4205-90-7), changes in plasma norepinephrine (NE) levels and urinary NE excretion as indices of the sympathetic nervous activities were investigated following transdermal and oral clonidine in conscious spontaneously hypertensive rats. Plasma NE levels were significantly reduced for 24 h during transdermal application of clonidine patch at 1.5 and 4.5 mg/kg on the back of each rat. Oral clonidine at 100 microgram/kg also lowered plasma NE levels. However, significant falls in the levels lasted only for 4 h after oral dosing. Urinary NE excretion was significantly decreased during both 4-8 and 8-24 h periods, and during an 8-24 h period following transdermal clonidine at 1.5 and 4.5 mg/kg, respectively. Significant decrease in urinary NE excretion was also produced during a 4-8 h period following oral clonidine at 100 micrograms/kg. Total urinary NE excretion during a 0-24 h period was dose-dependently reduced following transdermal clonidine, but was not altered following oral dosing. These findings suggest that the sympathoinhibitory effect of transdermal clonidine is more persistent than that of oral clonidine. Therefore, long-lasting antihypertensive effect of transdermal clonidine is closely associated with the sustained suppression of the sympathetic nervous activity.

Administration, Cutaneous↗
PubMed2002

[The use of nitroglycerin as nitric oxide donor for treatment of preterm labour].

OBJECTIVE: The aim of this study was the analysis of the effectiveness and safety of glyceryl trinitrate as a nitric oxide donor for treatment of preterm labour. PATIENTS AND METHODS: The study was carried out on 50 patients in preterm labour between 28 and 34 weeks of gestation receiving transdermal glyceryl trinitrate (GTN) patches (drug Nitroderm TTS 5 produced by Novartis Pharma AG, Bazylea). RESULTS: GTN patches appear to be a non-invasive method of suppressing uterine contractions in preterm labour. MAP and systolic blood pressure decreased significantly during the use of nitroglycerin. Diastolic blood pressure and maternal heart rate did not change during the treatment. Neither were significant changes in fetal heart rate or in fetal cardiotocographic recordings detected during or after the treatment. CONCLUSION: Transdermal glyceryl trinitrate (5 mg/day) may be promising as a safe and effective drug for treatment of preterm labour, especially in patients with higher blood pressure.

Administration, Cutaneous↗
PubMed1995

Postoperative analgesia and plasma levels after transdermal fentanyl for orthopedic surgery: double-blind comparison with placebo.

STUDY OBJECTIVE: To determine whether transdermal fentanyl can provide a significant component of postoperative analgesia. DESIGN: Randomized, double-blind study. SETTING: Inpatient surgery in a university hospital. PATIENTS: 40 adult patients scheduled for orthopedic surgery with general anesthesia. INTERVENTIONS: 20 patients in each group had general anesthesia with propofol, isoflurane in nitrous oxide and oxygen (O2), and small boli of alfentanil or sufentanil. Preoperatively, the first group (F) received a transdermal therapeutic system fentanyl patch (75 micrograms/hr) for 72 hours, and the second group (P) received a placebo patch. Morphine was given postoperatively according to clinical necessity. MEASUREMENTS AND MAIN RESULTS: Morphine consumption, pain visual analog scale, and eventual sedation were assessed, as well as respiratory rate and blood pressure. Plasma fentanyl concentrations were determined. Only 11 Group F patients needed morphine compared with 19 Group P patients, and mean morphine dose was significantly lower in Group F. One Group F patient had decreased O2 saturation and intense sedation, necessitating administration of naloxone. The mean maximum plasma fentanyl concentration in Group F was 1.63 ng/ml. CONCLUSION: Efficacy of transdermal fentanyl for postoperative pain relief is shown, but intense respiratory depression is sometimes seen.

Administration, Cutaneous↗