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PubMed2002

The effects of transdermal nicotine on inspection time.

RATIONALE: The acute administration of nicotine via a cigarette has been demonstrated to enhance inspection time (IT), a measure of rapid visual information processing, while the nicotinic antagonist mecamylamine impairs IT. However, as transdermal nicotine patches provide a slow delivery of nicotine, it is unclear if they produce similar effects to nicotine administered by more rapid methods. OBJECTIVES: To examine the effects of transdermal nicotine on inspection time. METHODS: Ten moderate smokers were administered nicotine (21 mg/day) or placebo via a transdermal patch in a randomized, double-blind, repeated measures design. Subjects were administered the IT task at baseline, then 1, 3, and 6 h subsequent to patch application. RESULTS: The change in IT from baseline was significantly different in the nicotine condition, relative to placebo, at 3 h but not 1 or 6 h. CONCLUSIONS: The findings suggest that nicotine administered via transdermal patches improves IT, but this improvement may be subject to tolerance. Data from previous studies on tolerance to the cognitive effects of nicotine have been inconclusive. However, the slow delivery of nicotine from patches may be more likely to produce such effects.

Administration, Cutaneous↗
PubMedDate not supplied

The effect of site of application on the transcutaneous absorption of 17-beta estradiol from a transdermal delivery system (Climara).

OBJECTIVE: The effect of site of application on 17-beta estradiol bioavailability was assessed in an open-label, randomized, crossover study of a once-weekly transdermal estradiol patch (Climara). DESIGN: After placement of a transdermal patch delivering 0.1 mg/day of estradiol on either the buttocks or abdomen, serial plasma samples were obtained over 7 days and for the immediate 24 h after patch removal. Plasma estradiol concentrations were used to estimate pharmacokinetic parameters for the rate and extent of absorption between the two sites. RESULTS: Plasma estradiol concentrations were sustained at premenopausal levels over the week in most subjects. After application on the buttock, mean peak plasma concentration (Cmax) was 125.1% and mean relative bioavailability (AUC(0-168)) was 117.2% of that from the abdomen site. CONCLUSIONS: In summary, the buttocks seem to be an acceptable site for the application for this once-weekly 17-beta estradiol transdermal delivery system. Because the extent of absorption was significantly more for buttock than for abdomen application, this application site may provide an advantage in women who experience menopausal symptoms at the end of the week.

Abdomen↗
PubMed1994

Characteristics and perceptions of nicotine patch users.

BACKGROUND: Although transdermal nicotine patches are frequently prescribed to aid in smoking cessation, little information exists about their use in general medical practice. In clinical studies, nicotine patches have been found to be effective when used in conjunction with nonpharmacologic interventions, such as physician counseling and follow-up visits. This study examines the characteristics and perceptions of patients regarding treatment with nicotine patches. METHODS: Patients filling or refilling prescriptions for a nicotine patch at 17 pharmacies were asked to complete a questionnaire. RESULTS: Seventy-six questionnaires were returned. Thirty-six percent of the respondents first learned about the nicotine patch from the media, 32% from friends, family, or co-workers, and 25% from their physicians. Most respondents (87%) had requested the patch, whereas only 9% had been asked by their prescriber to try the patch. Most of the surveyed smokers were highly motivated to quit, and 86% smoked at least one pack per day. Eighty percent indicated they had received a clear message from their physicians to quit, 56% said their physician had counseled them about relapse, and 55% had follow-up arranged. A quit date had been set by 37%, and only 24% reported the use of self-help materials. Approximately one half of smokers (54%) who had started using the patch indicated that they continued to smoke. CONCLUSIONS: Most respondents were good candidates for the nicotine patch based on how much they smoked and their motivation to quit. Direct-to-consumer advertising may have influenced many smokers to request treatment with the patch. Physicians should recognize that some persons may use the patch as a "quick fix," as very few respondents used the number of nonpharmacologic interventions that have proved useful in nicotine patch clinical trials. Physicians should follow the progress of patch users to ensure that they completely stop smoking during treatment.

Administration, Cutaneous↗
PubMed1999

Absorption and bioavailability of oestradiol from a gel, a patch and a tablet.

OBJECTIVES: To compare oestradiol and oestrone concentrations and bioavailability after a single dose and at a steady state during oral oestradiol valerate, transdermal oestradiol gel and transdermal oestradiol patch treatments. METHODS: Two open, randomised, cross-over studies were conducted. In the first study, 12 healthy postmenopausal women received 1.5 mg oestradiol as a transdermal gel or a 2 mg oestradiol valerate tablet daily for 14 days. In the second study, 15 postmenopausal women were treated for 18 days with 1.5 mg oestradiol gel or a transdermal patch releasing oestradiol 50 microg/24 h (replaced every 72 h). Venous blood samples for serum oestradiol and oestrone measurements with RIA were taken until 24 or 72 h after the first and last doses. RESULTS: The tablet and the transdermal gel yielded similar serum oestradiol profiles with a peak concentration 4-5 h after administration. The patch resulted in relatively stable oestradiol levels during the mid third of the wearing time whereas much lower levels were observed in the beginning and towards the end. There was no difference in the fluctuation between the peak and trough oestradiol levels between the gel (56 or 67%) and the tablet (54%) while the fluctuation was greater with the patch (89%). The bioavailability of oestradiol from the gel was 61% as compared with the tablet and 109% as compared with the patch. The gel was not bioequivalent with the tablet or the patch. CONCLUSIONS: The doses used of the transdermal gel and the patch roughly corresponded to each other with regard to the amount of oestradiol absorbed whereas the bioavailability from the tablet was significantly higher than from the gel. The lack of bioequivalence, the different serum oestradiol profiles and the large intersubject variability suggest that individual dose adjustments may be needed when changing administration form.

Administration, Cutaneous↗
PubMedDate not supplied

Safety, tolerability, and efficacy of continuous transdermal dopaminergic stimulation with rotigotine patch in early-stage idiopathic Parkinson disease.

Rotigotine is a new dopamine agonist with transdermal patch formulation for the treatment of Parkinson disease. The aim of this study was to investigate safety and efficacy of rotigotine in patients with early-stage Parkinson disease. In this open-label, dose-escalation, safety and efficacy study, 31 patients in the early stages of idiopathic Parkinson disease received rotigotine to a maximum of 18.0 mg/day. Of the 29 patients who completed the 28-day treatment phase, 24 were maintained at the maximum dose level. The drug was well tolerated, and skin reactions were mild. A statistically significant improvement in UPDRS I, II, and III scores was observed from baseline to end of treatment for the 29 subjects who completed the trial. Mean improvement (+/- standard deviation) was -0.41 +/- 0.78 on UPDRS I (P = 0.0078), -2.76 +/- 3.31 on UPDRS II (P = 0.0001), and -4.62 +/- 5.32 on UPDRS III (P < 0.0001). When results were stratified by maximum dose achieved, significant improvements were seen on all 3 subscores for patients achieving the maximum dose. These data suggest that rotigotine is a safe, well-tolerated, and effective treatment for early-stage Parkinson disease.

Administration, Cutaneous↗
PubMed1995

Sustained-release transdermal glyceryl trinitrate patches as a treatment for primary and secondary Raynaud's phenomenon.

A randomized, double-blind, placebo controlled, cross-over study was conducted to determine the clinical efficacy of and patient tolerance to sustained-release glyceryl trinitrate (GTN) patches in the treatment of Raynaud's phenomenon. The patients studied were those with primary Raynaud's disease (n = 21) and patients with Raynaud's phenomenon secondary to systemic sclerosis (n = 21). GTN patches (0.2 mg/h) were found to be effective in reducing the number (P < 0.05) and severity of Raynaud's attacks (P < 0.05) in both groups of patients. Objective assessments by infrared thermography did not show any significant improvement when the patients were on GTN patches (P > 0.05). Headaches, refractory to treatment, led to the withdrawal of eight patients from the study and occurred in approximately 80% of the remaining patients. Thus, in spite of the subjective efficacy, the frequent headaches will limit the use of GTN patches in Raynaud's phenomenon. Elucidating the mechanism of action of the beneficial and adverse effects of GTN at the molecular level may shed light on the pathogenesis of Raynaud's phenomenon and its treatment.

Administration, Cutaneous↗
PubMed1989

Responsiveness of peripheral veins to transdermal and sublingual nitroglycerin in healthy male volunteers.

Nitroglycerin (NTG) is a potent vascular smooth muscle relaxant. With the widespread use of transdermal NTG patches for the prophylaxis of angina, two important issues have arisen: (a) the relative efficacy of transdermal NTG patches compared to other formulations of NTG, and (b) the possibility of development of tolerance to transdermal NTG. We have investigated these two issues by studying the effect of systemically administered NTG (transdermal patches, ointment, and sublingual tablets) on alpha-adrenergic receptor agonist-mediated constriction of human dorsal hand veins. Nitroglycerin patches and ointment (15-60 mg/24 h) applied for 1-4 h did not modify the sensitivity (ED50) to the alpha-adrenergic agonist, phenylephrine. However, sublingual NTG (0.15-0.60 mg) administration caused significant relaxation of partially constricted veins. Following exposure for 24 h to a NTG patch (15 mg/24 h), NTG dose-response curves were not altered suggesting there was no development of tolerance to transdermal NTG. We conclude from our observations that tolerance to transdermal NTG does not appear in veins, possibly due to the low plasma NTG concentrations produced by this preparation. Our results also indicate that high doses of transdermal NTG do not modify phenylephrine-mediated constriction of peripheral veins in humans.

Administration, Cutaneous↗
PubMed2003

Transdermal delivery of chloroquine by amidated pectin hydrogel matrix patch in the rat.

The aim of the present study was to investigate the suitability of amidated pectin matrix patch for transdermal chloroquine delivery in an effort to mask the bitter taste when orally administered. Chloroquine has easily measurable outputs that are linked to increased renal Na+ excretion. We thus monitored urinary Na+ output in separate groups intravenously administered chloroquine or topically applied pectin hydrogel chloroquine matrix patch. Male groups of anesthetized Sprague-Dawley rats were placed on a continuous jugular infusion of 0.077 M NaCl at 150 microL min(-1). After 3 h equilibration period, consecutive 20 min urine collections were made over the subsequent 4 h of 1 h control, 1 h 20 min treatment, and 1 h 40 min recovery periods for measurements of urine flow and Na+ and K+ excretion rates. The effects of intravenous chloroquine infusion or topical application of pectin hydrogel chloroquine matrix patch were examined in rats in which the drug was added to the infusate or patch applied onto the shaved area during the 1 h 20 min treatment period. The animals were switched back to the infusate alone for the final 1 h 40 min recovery period. Vehicle infused animals acted as controls. Trunk blood was collected after the treatment period from parallel groups for chloroquine measurements. The plasma chloroquine concentrations following iv chloroquine or application of pectin chloroquine hydrogel matrix patch were 9.3 +/- 0.8 mg L(-1) and 7.3 +/- 1.1 mg L(-1) respectively (n = 7 in both groups). Chloroquine infusion and pectin chloroquine patch significantly (p < 0.01) increased Na+ excretion to peak values of 14.1 +/- 0.9 micromol min(-1). and 20.35 +/- 1.0 micromol min(-1), respectively by comparison with controls (9.1 +/- 0.9 micromol min(-1)), at the corresponding period. The results suggest that the pectin chloroquine patch matrix preparation has potential applications for transdermal delivery of chloroquine and perhaps in the management of malaria.

Administration, Cutaneous↗
PubMed2000

Effects of transdermal nicotine on craving, withdrawal and premenstrual symptomatology in short-term smoking abstinence during different phases of the menstrual cycle.

Gender differences in nicotine response with regard to nicotine sensitivity and withdrawal symptomatology have been reported, with the suggestion that ovarian hormones play a role. Few studies, however, have directly assessed hormonal influences on nicotine response. This study focused on the effects of a transdermal nicotine patch in women during acute smoking abstinence when tested in different phases of their menstrual cycle. Thirty women were randomized to order of menstrual cycle phase (late luteal or follicular) and patch condition (active or placebo). Two 7-day outpatient-testing periods were conducted with 2 days of ad lib baseline smoking and 5 days of smoking abstinence. Dependent measures included scores from the Minnesota Nicotine Withdrawal Scale, Questionnaire on Smoking Urges, and Premenstrual Assessment Form, as well as weight. The severity of both premenstrual symptomatology and nicotine withdrawal symptoms was greater in the late luteal phase. Correlation coefficients confirmed overlap between premenstrual and withdrawal symptomatology, especially for the affect subscale. A significant patch effect was observed, showing diminished craving and premenstrual affect on pain subscale scores for women on active patch. Results showed that nicotine craving and premenstrual pain and water retention symptoms were diminished in women on transdermal patch, and that this effect was greatest in the late luteal phase. In addition, the greatest weight gain was demonstrated for participants in the late luteal phase, placebo condition. In summary, during short-term smoking abstinence in women, transdermal nicotine appears to have a more pronounced effect in the late luteal phase than in the follicular phase in reducing craving and certain premenstrual symptoms.

Administration, Cutaneous↗
PubMed1997

Effects of intermittent transdermal nitroglycerin on occurrence of ischemia after patch removal: results of the second transdermal intermittent dosing evaluation study (TIDES-II).

OBJECTIVES: We sought to evaluate the effects of intermittent transdermal nitroglycerin (TD-NTG) on the occurrence of ischemia during patch-off hours in patients with stable angina pectoris receiving a beta-adrenergic blocking agent or calcium antagonist, or both. BACKGROUND: The current recommendations for the use of intermittent TD-NTG may be associated with the occurrence of rebound ischemia. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, crossover trial with three study periods. Tolerability to TD-NTG was assessed in Period I. Seventy-two patients were assigned to receive either double-blind transdermal placebo or maximally tolerated TD-NTG for 2 weeks (Period II) and were then crossed over to the alternative treatment for another 2 weeks (Period III). The patients were instructed to apply medication daily at 8 AM, to remove it at 10 PM and to note symptoms and sublingual nitroglycerin (SL-NTG) use in a diary. The occurrence of ischemia was assessed from patient-perceived angina, symptom-limited exercise treadmill test (ETT) and 48-h ambulatory electrocardiographic (AECG) monitoring. RESULTS: Transdermal NTG (0.2 to 0.4 mg/h) significantly reduced the magnitude of ST segment depression at angina onset during ETT compared with placebo. Total angina frequency was not significantly different between TD-NTG (mean [+/-SD] 3.2 +/- 4.2) and placebo (3.3 +/- 5.2). During patch-off hours, angina frequency increased with TD-NTG (1.1 +/- 2.1) compared with placebo (0.7 +/- 1.6) (p = 0.03). Similar trends for an increase in ischemia after TD-NTG were also observed from AECG analyses. Specifically, ischemia frequency tended to be lower during patch-off hours for placebo than with TD-NTG (0.05 +/- 0.09 vs. 0.08 +/- 0.20 episodes/h, respectively, p = 0.08), even though frequency of ischemia tended to be higher during patch-on hours for placebo than with TD-NTG (0.12 +/- 0.19 vs. 0.07 +/- 0.15 episodes/h, respectively, p = 0.11). During placebo, ischemia frequency decreased 58% (patch-on to patch-off, p = 0.01) compared with a 14% increase with TD-NTG. These changes attenuate the usual circadian variation in ischemia. CONCLUSIONS: An increase in ischemia frequency during patch-off hours after use of intermittent TD-NTG was perceived by patients, and this subjective finding was supported by a corresponding trend for AECG ischemia to increase during these same hours.

Administration, Cutaneous↗
PubMed2003

Acrylate-based transdermal therapeutic system of nitrendipine.

The objective of the present research investigation was to fabricate an acrylate-based transdermal therapeutic system (TTS) of nitrendipine, which could deliver drug at maximum input rate so as to deliver drug in minimum patch size. Transdermal patches were fabricated using synthesized acrylate pressure-sensitive adhesives (PSAs): PSA1, PSA2, and commercially available PSA3 and PSA4 using d-limonene as permeation enhancer. Effect of concentration of d-limonene on permeation kinetics of nitrendipine in PSAs was studied. Fabricated TTS in mentioned PSAs were evaluated for in-vitro release and permeation kinetics through guinea-pig skin. Cumulative release of drug in PSA1, PSA2, PSA3, and PSA4 was observed to be 45%, 40%, 25%, and 25%, respectively, upto 24 hr. Flux of drug through guinea-pig skin calculated at 48 hr in PSA1, PSA2, PSA3, and PSA4, with and without d-limonene, was observed to be 0.346+/-0.10, 0.435+/-0.17, 0.410+/-0.17, and 0.162+/-0.06, and 0.625+/-0.19, 1.161+/-0.46, 0.506+/-0.17, and 0.520+/-0.18 (microg/cm2/hr), respectively. The TTS in PSA2 showed comparatively high flux and could deliver drug at high input rate through transdermal route. PSA2 was found to have good rate-controlling property and could be successfully employed in transdermal delivery of nitrendipine.

Acrylates↗
PubMed1987

Transdermal scopolamine: effects of single and repeated patches upon psychological task performance.

Scopolamine and placebo transdermal patches were applied on alternating days to 12 normal volunteer subjects. Psychological performance tasks, physiological assessments, a subjective feeling state questionnaire, and a sleep questionnaire were completed each day. Transdermal scopolamine produced significant decrements in memory task performance, daytime feelings of alertness, ease of waking, and alertness following waking, while resting heart rates were lowered. Significant drug x patch number interaction effects were present with memory for new information, letter cancellation omission errors, rapid visual information processing reaction time, and self-rated ease of getting to sleep, but there was no consistent pattern to the changes following successive patches. Visual problems (blurred vision, longer visual near point) increased following successive scopolamine patches, but the changes in task performance were not related to these visual changes.

Administration, Cutaneous↗
PubMedDate not supplied

Progress in contraception: new technology.

Unintended pregnancy continues to be a major public health issue in this country. Approximately 50% of pregnancies in the United States are unintended, and, of these, half end in abortion. Although tubal sterilization is highly effective, many women subsequently express regret and remorse. Oral contraceptives represent an effective, reversible method. However, many women have difficulty using them consistently and correctly. Recently, four new delivery systems for hormonal contraception have become available in the United States: the monthly injection, the levonorgestrel intrauterine system, the combination hormonal contraceptive vaginal ring, and the transdermal contraceptive patch. All four new methods are effective, readily reversible, generally discreet, and reduce daily compliance challenges. The monthly injection, vaginal ring, and transdermal patch can be discontinued without the need for an office visit. This expanded menu of effective contraceptive options should help women find a method that suits their particular life style.

Administration, Intravaginal↗
PubMed1992

Postoperative pain control by transdermal fentanyl. Preliminary comparison of two dosages to a fixed-interval i.m. morphine regimen.

The efficacy of postoperative pain control with two doses of transdermal fentanyl were compared to a fixed-interval intramuscular (i.m.) morphine regimen in 21 patients undergoing orthopedic surgical procedures. The two transdermal fentanyl patches with delivery rates of 70-80 micrograms/hr and 90-100 micrograms/hr, groups one and two, respectively, were compared to an i.m. morphine regimen of 150 micrograms/kg every 6h, group three. Transdermal patches were applied one hour prior to surgery and removed after 24h. Analgesia, safety scores, side effects, and a global postoperative evaluation were recorded by a blinded physician at frequent intervals up to 36h. No significant difference in pain intensity, evaluated by the visual analog scale, were found between the three groups. Group two had the lowest discomfort score. Groups one and two had a significantly lower respiratory rate than group three. Although there were isolated significant differences in peripheral hemoglobin saturations, these differences were not consistent. This is the first study in which transdermal fentanyl was compared to a fixed-interval i.m. morphine protocol without supplementation with other narcotics. The results show that fentanyl by a transdermal route can provide analgesia comparable to i.m. morphine. No clinically important adverse side effects were found in any of the study groups.

Administration, Cutaneous↗
PubMed2001

A safe and effective method for converting cancer patients from intravenous to transdermal fentanyl.

BACKGROUND: Therapeutic fentanyl blood levels are reached approximately 12-16 hours after the initial application of transdermal fentanyl patches. For this reason, fentanyl patches should not be used to treat acute exacerbations of cancer pain. Acute cancer-related pain can be treated with fentanyl administered by continuous intravenous infusion (CII) in combination with patient-controlled analgesia (PCA). Patients then can be switched from intravenous (IV) to transdermal fentanyl once stable pain relief has been achieved. The objective of the current case series was to evaluate and describe the safety and effectiveness of a method for converting hospitalized patients with cancer-related pain from IV to transdermal fentanyl. METHODS: The authors prospectively evaluated 15 consecutive cancer patients during the conversion from IV to transdermal fentanyl. In all patients, a transdermal patch delivering fentanyl at a rate equivalent to that of the final continuous IV infusion was applied. The CII rate was decreased by 50% 6 hours after application of the fentanyl patch and then discontinued after another 6 hours. Demand boluses of IV fentanyl equivalent in dosage to 50-100% of the final CII rate remained available via PCA during the 24 hours after patch application. Pain intensity (on a scale of 0-10), sedation (on a scale of 0-3), and hourly PCA administration (microg/hr) were assessed and recorded immediately prior to application of the fentanyl patch and 6, 12, 18, and 24 hours thereafter. RESULTS: Pain intensity, sedation, and hourly PCA administration appeared to remain stable throughout the transition from IV to transdermal fentanyl. CONCLUSIONS: The results of the current study demonstrate that the conversion from IV to transdermal fentanyl can be accomplished safely and effectively using a 1:1 (IV:transdermal) conversion ratio and a two-step taper of the CII over 12 hours.

Administration, Cutaneous↗