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PubMed2003

The androgen-deficient aging male: current treatment options.

All delivery forms of testosterone should be equally efficacious in treating the androgen-deficient aging male if adequate serum testosterone levels are obtained. The testosterone preparations available in North America include the oral undecanoate, injectable testosterone esters, the scrotal patch, the nonscrotal transdermal patch, and the transdermal gels. Selection of a specific testosterone preparation for replacement therapy depends on many factors, including the magnitude and pattern of serum testosterone levels produced, side effects of the particular formulation, reversibility if an adverse event should occur, convenience of use, cosmetic issues related to the preparation, and cost. In addition, potential adverse effects of testosterone therapy applicable to all forms of testosterone delivery, such as fluid retention, gynecomastia, polycythemia, worsening of sleep apnea, change in cardiovascular-disease risk, or alterations in prostate health, need to be considered both prior to therapy and during treatment monitoring.

Journal Article↗
PubMedDate not supplied

Locally applied transdermal nitrate patches for the treatment of ischaemic rest pain.

Patients with severe peripheral vascular disease may suffer considerable pain which can be difficult to control with conventional analgesics. We sought to assess the analgesic effect of transdermal nitrate patches in such patients. A prospective trial was performed in 15 patients with ischaemic rest pain due to atherosclerotic peripheral vascular disease. Pain control and oral analgesic requirement were assessed. Fourteen of the 15 had a good or moderate response to the nitrate patches with a subsequent reduction in oral analgesic requirement. The patients with primarily small vessel disease had the greatest improvement in pain control. We conclude that topical nitrates may be used to provide rapid and safe analgesia for patients with ischaemic rest pain.

Administration, Cutaneous↗
PubMed1997

Effectiveness of a 24-hour transdermal nicotine patch in conjunction with a cognitive behavioural programme: one year outcome.

Hospital-based outpatients participating in a cognitive-behavioural group programme (2 hours/week over 5 weeks) were studied to evaluate the effectiveness of a 24-hour transdermal nicotine patch in assisting smokers to stop smoking when used as an adjunct to a cognitive-behavioural group programme, and to assess weight gain following cessation, using a randomized, double-blind, placebo-controlled trial with 12 months' follow-up. The main outcome measure was a comparison between point prevalence abstinence, continuous abstinence and 12-months sustained, biochemically validated abstinence. The validated abstinence rates at 12 months for point prevalence, sustained and continuous abstinence for subjects in the active and placebo groups were all statistically significant: 28 vs. 12%; 24 vs. 11%; and 19 vs. 9%, respectively. Moderately dependent smokers using the nicotine patch were more successful than highly dependent smokers at 3 and 6 months (p < 0.05). Weight gain was greater among sustained abstainers at 12 months compared to continuing smokers (p < 0.001). When the active nicotine patch was used in combination with cognitive-behavioural therapy in an outpatient hospital clinic, 12-months sustained abstinence rates were more than double those of a placebo patch.

Administration, Cutaneous↗
PubMed1989

Hydrogel patches for transdermal drug delivery; in-vivo water exchange and skin compatibility.

Hydrogel patches based on water swellable polyacrylates have been developed for long-term transdermal drug delivery. Two properties, relevant to the performance of hydrogel patches in-vivo have been investigated in humans over five days. These were: (i) the kinetics of water exchange between the skin and the patches; (ii) the skin compatibility of the patches. It was found that initially there was a gradually increasing uptake of water from the skin by the patches, but after about 20 h the water exchange followed a regular fluctuating pattern, peaking once a day and once a night. The skin compatibility of the patches was satisfactory, in that no redness or pustulation was noticed throughout the five days. This was most likely due to the capability of the patches to exchange water with the skin.

Administration, Cutaneous↗
PubMed1990

Nicotine-replacement therapy with use of a transdermal nicotine patch--a randomized double-blind placebo-controlled trial.

The rate of smoking was significantly reduced in volunteer subjects by providing effective nicotine replacement, self-help material, and weekly visits with a nurse for 6 weeks. Nicotine-replacement therapy with a transdermal nicotine patch (Nicolan) almost doubled the 6-week smoking-cessation rate in comparison with that in a placebo group (77% versus 39%; P = 0.002) among subjects who were smoking at least 20 cigarettes per day at baseline. Although most subjects who used the active nicotine patches had skin reactions, the reactions were primarily mild. For use of both active and placebo patches, the level of patient compliance was high. Among subjects who continued to smoke, the use of cigarettes was decreased to less than 50% of the baseline smoking level in 7 of 7 with active nicotine patches and in 15 of 19 with placebo patches. Outcomes beyond 6 weeks showed a substantial relapse rate in both groups. Thus, when nicotine-replacement therapy is provided, a need exists for concurrent behavioral intervention and training for prevention of a relapse, neither of which was part of this protocol.

Administration, Cutaneous↗
PubMed2000

Transdermal delivery of drugs for the treatment of bone diseases.

The current status of transdermal drug delivery for the treatment of bone diseases is described in this review. The structure, physiology and function of skin and their importance in determining delivery into and across skin are discussed. Special emphasis has been devoted to a description of the major pathways of transport across the skin and the quite continuing controversy over the importance of the transfollicular route. An overview of anatomic site-dependent drug absorption is also provided and is particularly relevant to determination of transdermal patch location. Brief descriptions of the criteria for selection of transdermal drug candidate, transdermal patch designs and currently marketed transdermal products are also included. Transdermal estradiol delivery systems are examined in more detail for their clinical and biological effects. Finally, the feasibility of delivering drugs such as bisphosphonates across skin is discussed.

Administration, Cutaneous↗
PubMedDate not supplied

Comparing patient telephone callback rates for different hormonal birth control delivery systems.

This study was conducted to determine the number of office telephone callbacks in the first 3 months after initiating use of the vaginal ring, the transdermal patch, or an oral contraceptive. If a patient called back, the reason for her call was noted. Patients were prospectively followed from sites in New Jersey and Florida for 3 months after initiation of hormonal contraception (oral, transdermal, vaginal) and the number of callbacks for each method was assessed. Before study recruitment, the patients had either never used or discontinued hormonal contraception for at least 1 month. All patients were given standard counseling, which included reference handouts specific to their chosen form of contraception. The number of callbacks for patients on oral contraceptives was 30/96 (26 patients, 4 of the 26 with 2 callbacks each); for the transdermal patch, 20/40 (17 patients, 3 of the 17 with 2 callbacks each); and for the vaginal ring, 11/72 (11 patients). Pearson chi2 analysis revealed that all 3 groups were significantly different from each other (P = 0.0004). Most patients called back for side effects related to their method of choice, and some patients called back more than once. Rate of callbacks after initiation of hormonal contraception was the least with the vaginal ring. Use of oral contraception, often considered the gold standard, resulted in a callback rate that was midway between the number of callbacks for the vaginal ring and the number of callbacks for the transdermal patch. The lower observed rate of callbacks with the vaginal ring compared with oral and transdermal contraception may provide clinicians the confidence that this method is well tolerated by their patients.

Administration, Cutaneous↗
PubMed2006

Development and in vitro/in vivo evaluations of bioadhesive buccal tablets for nicotine replacement therapy.

Buccal bioadhesive tablet formulations of nicotine hydrogen tartrate (NHT) for nicotine replacement therapy (NRT) were developed using chitosan and carbomer at different ratios. Magnesium hydroxide was incorporated into the formulations as pH increasing agent. In vitro release and bioadhesion properties of the tablets were investigated. Release of NHT from the tablets was increased with the increasing amount of chitosan in formulations whilst the bioadhesion of the tablet was decreased. In vivo studies were carried out in healthy, non-smoker volunteers in comparison to a commercially available transdermal patch. Plasma nicotine and cotinine levels were determined using gas chromatography-mass spectrophotometry. No significant difference was found between the maximum plasma nicotine concentrations (Cmax) obtained with the buccal tablet and the transdermal patch (p > 0.05). Time to reach the Cmax was 2.9 +/- 0.2 h and 11.5 +/- 1.3 h, and AUC0-24 values were 59.3 +/- 5.1 ng x h x mL(-1) (0-12 h) and 204.1 +/- 31.2 ng x h x mL(-1) for buccal tablet and transdermal patch, respectively.

Acrylic Resins↗
PubMed1996

Effect of 21 mg transdermal nicotine patches and smoking cessation on heart rate variability.

The effect of smoking cessation on cardiac autonomic tone, as reflected by indexes of heart rate variability (HRV), has not been reported. Current smokers (n = 54, mean +/- SD age 43 +/- 12 years) who desired to quit, and were smoking > or = 1 pack/day and had made > or = 1 prior attempt at quitting, had 24-hour electrocardiographic recordings. They then attended smoking cessation classes and used transdermal nicotine patches while abstaining from smoking. After 4 to 6 weeks of using 21 mg patches, the 24-hour electrocardiogram was repeated (n = 35). Four weeks after cessation of patch use, the 24-hour electrocardiogram was again recorded in subjects who continued to be abstinent (n = 25). Time and frequency domain measures of HRV based on normal R to R (NN) intervals were computed for all recordings. Smoking cessation significantly decreased heart rate, and increased all 24-hour time and frequency domain indexes of HRV. Part of this change occurred in the transition from smoking to the patch, and further changes occurred with cessation of patch use. For example, the standard deviation of average NN intervals was 114 +/- 28 ms at baseline, 121 +/- 41 ms with the patch, and 135 +/- 26 ms after quitting. At 4 weeks after cessation of all nicotine use, the average heart rate remained higher, and HRV remained lower than values reported for healthy, middle-aged adults.

Administration, Cutaneous↗
PubMed2005

In vitro/in vivo correlation of transdermal naltrexone prodrugs in hairless guinea pigs.

PURPOSE: The purpose of this investigation was to evaluate the in vitro and in vivo percutaneous absorption of the following prodrugs of naltrexone (NTX): 2'-ethylbutyryl-3-O-ester-NTX (ETBUT-ester), methyl-3-O-carbonate-NTX (ME-carbonate), ethyl-3-O-carbamate-NTX (ET-carbamate), and N,N-dimethyl-3-O-carbamate-NTX (DME-carbamate) in hairless guinea pigs. METHODS: In vitro fluxes of NTX and its prodrugs through guinea pig skin were determined using a flow-through diffusion cell system. The pharmacokinetics of NTX prodrugs were determined after topical application of transdermal patches in guinea pigs. RESULTS: All the prodrugs hydrolyzed to NTX on passing through the skin, and ME-carbonate provided the highest NTX flux and had the highest apparent permeability coefficient (K(p)). ME-carbonate and ET-carbamate underwent the highest extent of bioconversion to NTX upon passing through the skin as compared to ETBUT-ester and DME-carbamate. The results of the in vivo studies indicated that a significant amount of NTX was delivered after the application of transdermal patches of NTX prodrugs. A mean steady-state plasma concentration of 7.1 ng/ml was obtained after the application of transdermal patches of ME-carbonate. A good correlation was obtained between the in vitro and in vivo results. CONCLUSIONS: The results of the in vivo studies indicated that the ME-carbonate prodrug of NTX was the most promising drug candidate for transdermal delivery.

Administration, Cutaneous↗
PubMed2002

[Tolerability and efficiency of a new transdermic nitroglycerin patch in outpatients with chronic stable angina. The PATRICH Trial].

OBJECTIVE: To obtain data on local and systemic tolerability of three different doses (5 mg/24 h, 10 mg/24 h, and 15 mg/24 h) of a new model of nitroglycerin patch (Trinipatch, Sanofi-Synthelabo, S. A.) in patients with chronic stable angina. METHODS: A total of 954 patients were studied for a follow-up period of 12 weeks. Patients were distributed as follows: 132 to the 5 mg/24 h patch, 727 to the 10 mg/24 h patch, and 95 to the 15 mg/24 h patch. The local tolerability was evaluated by using the Draize scale and the systemic tolerability by recording the adverse reactions and assessing the effect on blood pressure. Furthermore, the efficiency of therapy was evaluated by means of the variations observed in the number and severity of angina crises, as well as the weekly use of sublingual nitroglycerine. RESULTS: Ninety-four patients (9.8%) showed signs of cutaneous irritation. Thirty-two patients (3.3%) showed erythema, and one patient (0.1%) showed erythema and induration. Thirty-nine patients (4.1%) had some type of systemic adverse reaction during the study. A total of 44 adverse reactions were recorded, headache being the most common (79.5%). Only one severe adverse reaction was observed (mild heart failure), which in the opinion of the researcher was not related to the medication. No dropouts were recorded on account of adverse reactions. The number of patients with angina crises and the number of weekly angina crises decreased significantly with therapy. CONCLUSIONS: The transdermic nitroglycerin patch was demonstrated to be a safe and well tolerated therapy for chronic stable angina, both in terms of local and systemic tolerability. Moreover, its efficiency was demonstrated as the number of angina crises decreased significantly.

Administration, Cutaneous↗
PubMed1998

Transdermal nicotine effects on attention.

Nicotine has been shown to improve attentiveness in smokers and attenuate attentional deficits in Alzheimer's disease patients, schizophrenics and adults with attention-deficit/hyperactivity disorder (ADHD). The current study was conducted to determine whether nicotine administered via transdermal patches would improve attentiveness in non-smoking adults without attentional deficits. The subjects underwent the nicotine and placebo exposure in a counterbalanced double-blind manner. Measures of treatment effect included the Profile of Mood States (POMS), Conners' computerized Continuous Performance Test (CPT) of attentiveness and a computerized interval-timing task. The subjects were administered a 7 mg/day nicotine transdermal patch for 4.5 h during a morning session. Nicotine significantly increased self-perceived vigor as measured by the POMS test. On the CPT, nicotine significantly decreased the number of errors of omission without causing increases in either errors of commission or correct hit reaction time. Nicotine also significantly decreased the variance of hit reaction time and the composite measure of attentiveness. This study shows that, in addition to reducing attentional impairment, nicotine administered via transdermal patches can improve attentiveness in normal adult non-smokers.

Administration, Cutaneous↗
PubMed2002

Allergic reactions to glyceryl trinitrate and isosorbide dinitrate demonstrating cross-sensitivity.

Glyceryl trinitrate (nitroglycerin) has been in use for relief of angina for over a hundred years, but allergic reactions to it or to other organic nitrates rarely feature in the medical literature. Most of the case reports describe reactions to transdermally applied nitroglycerin. We report a case of a localized allergic reaction to nitroglycerin transdermal patches that developed when these were worn for the first time after 7 days of uneventful treatment with intravenous isosorbide dinitrate. The reaction evolved into a severe and generalized maculopapular rash with facial swelling when intravenous isosorbide dinitrate was re-administered 10 days later. Subsequent patch testing with a transdermal nitroglycerin patch and a placebo nitroglycerin-free patch provoked a reaction to the nitroglycerin patch but not to the placebo, thus excluding allergy to other constituents of the nitroglycerin patch.

Administration, Cutaneous↗
PubMed1996

Importance of baseline cotinine plasma values in smoking cessation: results from a double-blind study with nicotine patch.

Nicotine replacement by transdermal patches is more effective than placebo in smoking cessation, but has a low success rate after one year (9-18%). We tested whether this was attributed to insufficient nicotine replacement. We conducted a randomized trial to investigate the effect on outcome of different doses of transdermal nicotine replacement after stratification according to baseline plasma cotinine values. Two hundred and ninety seven adult smokers were enrolled. Those with baseline cotinine < or = 250 ng.ml-1 (low cotinine) were randomly assigned to placebo (LC-P) or to 15 mg 16 h nicotine patches (LC-15), and those with baseline cotinine > 250 ng.mL-1 (high cotinine) were randomly assigned to 15 mg (HC-15) or 25 mg (HC-25) 16 h nicotine patches. Plasma nicotine and cotinine values, expired carbon monoxide and withdrawal symptoms were measured at scheduled intervals during treatment. Smokers in the LC-15 group had a significantly higher success rate than placebo (28 vs 9%). Smokers with high baseline cotinine had lower success rates, and a high dose of nicotine did not increase success rate (HC-25 9% vs HC-15 11%). Subjects in the HC-15 group had the lowest percentage of nicotine replacement and a higher prevalence of withdrawal symptoms than the HC-25 group. Replacement was similar in groups LC-15 and HC-25, but the success rate was significantly lower in HC-25 group, despite similar levels of withdrawal symptoms. We conclude that a higher success rate was obtained after one year in smokers with low baseline plasma cotinine values. Determination of plasma cotinine values may be, thus, helpful in identifying smokers who could benefit from transdermal nicotine replacement.

Adult↗
PubMedDate not supplied

Efficacy and safety of a seven-day, transdermal estradiol drug-delivery system: comparison with conjugated estrogens and placebo. The Transdermal Estradiol Patch Study Group.

OBJECTIVE: To evaluate the efficacy and safety of a new, seven-day, transdermal estradiol system in healthy postmenopausal women with hot flushes. METHODS: Two studies are described. In the first study, subjects were randomized to treatment with a 0.05 mg/day estradiol patch, a 0.1 mg/day estradiol patch, or a placebo patch; and in the second study, to treatment with either of the two estradiol patches or oral conjugated estrogens (as Premarin) 0.625 mg/day. Efficacy was evaluated on the basis of diary entries recording hot-flush frequency and severity. Subjects' and investigators' global assessments of treatment efficacy were recorded at follow-up visits. RESULTS: In Study 1, both the 0.05-mg and 0.1-mg estradiol patches were significantly more effective than placebo in reducing hot flushes and were associated with higher global assessments. In Study 2, all three active treatments produced a significant reduction in the number of hot flushes compared with base-line. There were no statistically significant between-group differences, although the response to the 0.1-mg estradiol patch was greater, and to the 0.05-mg estradiol patch less, than the response to conjugated estrogens. The patches were generally well tolerated. Skin irritation from the patch was the most common adverse experience in both studies. CONCLUSIONS: The new, seven-day, transdermal system effectively and safely treats post-menopausal vasomotor symptoms.

Administration, Cutaneous↗
PubMed2000

Water-activated, pH-controlled patch in transdermal administration of timolol. II. Drug absorption and skin irritation.

The feasibility of the water-activated, pH-controlled silicone reservoir devices for transdermal administration was investigated using timolol maleate as a model drug. Timolol patches were applied to the arm of 12 volunteers for 81 h, two patches per subject. Timolol absorption from patches was compared to that from a peroral timolol tablet formulation (Blocanol((R)) 10 mg). Furthermore, in vivo plasma levels of timolol were compared with those predicted by kinetic simulations. Skin irritation induced by timolol patches was assessed by visual scoring and color reflectance measurements. With water-activated, pH-controlled patches both steady-state concentrations of timolol in plasma and its duration could be controlled. However, a considerable, inter-individual variability in the transdermal absorption of timolol was observed. This is due to the high fractional skin control in timolol delivery. Timolol patches were well tolerated by subjects. Skin irritation induced by the combination of timolol with long-term occlusion was mild, and after removal of the patches, skin changes were practically reversed in 24 h. Simulation model was useful in prediction of timolol levels in plasma after transdermal administration.

Administration, Cutaneous↗
PubMed2000

Estradiol pharmacokinetics after transdermal application of patches to postmenopausal women: matrix versus reservoir patches.

OBJECTIVE: A new matrix 17 beta-estradiol transdermal patch incorporating lauric acid to improve estradiol skin absorption has been designed for hormone replacement therapy. Estradiol pharmacokinetics obtained with the prototype, its industrial counterpart, a matrix-type, System 50, and a reservoir-type, Estraderm TTS 50, transdermal patch have been compared. Each device delivers 50 micrograms estradiol daily. METHODS: Twenty postmenopausal women received each of the four formulations for 3 days in a Latin-square design and with a minimum 4-day wash-out period between treatments. Estradiol plasma concentrations were measured by radioimmunoassay at 6, 12, 24, 48 and 72 h after application. RESULTS: The prototype patch and its industrial counterpart showed no significant difference in estradiol delivery, with 72-h systemic exposure to estradiol similar to that of the reservoir patch but greater than that of the reference matrix formulation, with average baseline-corrected concentrations (SEM) of 35 (4), 32 (3), 32 (2) and 19 (1.8) pg/ml, respectively. In addition, they ensured more stable delivery, with coefficients of variation of plasma estradiol concentrations (12-72 h) of 29, 41, 63 and 84%, respectively. All matrix patches demonstrated the same patients to be poor estradiol absorbers, different from those encountered with the reservoir patch type, despite an improved estradiol bioavailability with the lauric acid-containing matrix patch. CONCLUSION: Matrix patches incorporating lauric acid led to estradiol plasma levels more stable than with the reference matrix and reservoir patches, and greater than those with the reference matrix patch.

Administration, Cutaneous↗
PubMed2003

Chronic transdermal nicotine patch treatment effects on cognitive performance in age-associated memory impairment.

OBJECTIVES: Chronic transdermal nicotine has been found to improve attentional performance in patients with Alzheimer's disease (AD), but little is known about chronic nicotine effects in age-associated memory impairment (AAMI), a milder form of cognitive dysfunction. The current study was performed to determine the clinical and neuropsychological effects of chronic transdermal nicotine in AAMI subjects over a 4-week period. DESIGN: The double-blind, placebo-controlled, cross-over study consisted of two 4-week periods separated by a 2-week washout period. SETTING: An outpatient setting was used. PARTICIPANTS: The subjects ( n=11) met criteria for AAMI. INTERVENTIONS: The subjects were given nicotine patches (Nicotrol) to wear for 16 h a day at the following doses: 5 mg/day during week 1, 10 mg/day during week 2 and week 3 and 5 mg/day during week 4. MEASUREMENTS: The effects of nicotine treatment were determined with the clinical global impressions questionnaire, Conners' Continuous Performance test, and the automated neuropsychologic assessment metrics (ANAM) computerized neuropsychology battery. RESULTS: Nicotine significantly improved the clinical global impression score as assessed by participants, as well as objective tests of attentional function on the Connors' Continuous Performance Test and decision reaction time on the neuropsychology test battery. Nicotine did not improve performance on other tests measuring motor and memory function. CONCLUSION: Chronic transdermal nicotine treatment in AAMI subjects caused a sustained improvement in clinical symptoms and objective computerized tests of attention. These results support the further investigation of nicotinic treatment as a promising therapy for AAMI.

Administration, Cutaneous↗