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PubMed1995

Combined use of nicotine patch and gum in smoking cessation: a placebo-controlled clinical trial.

BACKGROUND: Smoking is considered as an addiction to nicotine for most subjects consuming 10 cigarettes or more per day. Hence, nicotine replacement therapy by way of gum, patch, or spray has been advocated. The rationale of this study is to evaluate the possible beneficial effects of adding nicotine gum to the routine of subjects using the nicotine patch. The effect of the nicotine patch against the placebo, both groups receiving placebo nicotine gum, has also been assessed. METHODS: Healthy subjects (374) were randomized at their work-setting in a 1-year double-blind placebo-controlled trial: 149 subjects to active nicotine patch + active gum (group 1), 150 to active nicotine patch + placebo gum (group 2), and 75 to placebo patch + gum (group 3). Treatment duration was 12 weeks with a 16-hr transdermal patch of 15 mg, followed by a 6 + 6-weeks weaning period on respectively 10 and 5 mg patches. Gum use was not restricted during the first 6 months, with recommendations to use at least four pieces a day. A strict definition of smoking abstinence was used in this study, which did not allow smoking any cigarette after Week 1. Nonsmoking status at each visit, as reported by the subjects, was verified by CO below 10 ppm in expired air. RESULTS: Abstinence rates in group 1 against group 2 were 34.2 and 22.7% (P = 0.027) at 12 weeks, 27.5 and 15.3% (P = 0.010) at 24 weeks, and 18.1 and 12.7% (P = 0.191) at 52 weeks. In group 3, abstinence rates were 17.3, 14.7, and 13.3% respectively at 12, 24, and 52 weeks. Using logistic regression with adjustment for six baseline covariates, odds ratios for abstinence (with 95% CI) were computed. For group 1/group 2, OR at 12, 24, and 52 weeks were 1.72 (1.03-2.94) (P = 0.039), 2.04 (1.14-3.57) (P = 0.018), and 1.47 (0.76-2.76) (P = 0.125). No significant differences in OR were observed when comparing groups 2 and 3. Time to relapse is significantly longer in group 1 as compared to that of group 2 (P = 0.041), whereas no significant differences between groups 2 and 3 were observed. No significant differences between the three groups in systemic and local adverse drug events were observed. CONCLUSION: Adding active gum use to active patch use in subjects smoking 10 cigarettes or more a day increased abstinence rates, which are statistically significant up to 24 weeks.

Administration, Cutaneous↗
PubMed1994

Transdermal scopolamine for the reduction of postoperative nausea in outpatient ear surgery: a double-blind, randomized study.

We evaluated the effect of transdermal scopolamine on the incidence of postoperative nausea and vertigo after outpatient ear surgery (exploratory tympanotomy, mastoidectomy, or endolymphatic sac and oval and round window surgery) in a double-blind, placebo-controlled study. A transdermal patch containing either scopolamine (n = 19) or placebo (n = 20) was placed behind the nonsurgical ear 2 h before surgery. Anesthesia was induced with thiopental (4-6 mg/kg intravenously [i.v.]), sufentanil (0.5 microgram/kg i.v.), and vecuronium (0.1 mg/kg i.v.) and maintained with isoflurane (0.2%-2%) and nitrous oxide (70%) in oxygen. Patients were observed postoperatively in the recovery room and after discharge for 72 h. There was no significant difference between groups with respect to time in recovery room, time to discharge, incidence of in-house nausea, vomiting, amount of antiemetics required, or postoperative visual analog scale (VAS) scores while in the hospital. After discharge, there were lower VAS nausea scores (by repeat measures analysis, P < 0.05) and a lower reported incidence of nausea (31% vs 62%; P < 0.05) and vertigo (6.2% vs 25%; P < 0.05) in the active patch group versus the placebo group. There was a higher incidence of dry mouth in the active patch group (44% vs 25%). Seven patients did not complete the study due to failure to keep the patch in place or failure to return the diary from home; and one patient from the placebo patch group was admitted for uncontrolled nausea and vomiting. The authors concluded that transdermal scopolamine is effective in reducing, but not eliminating, postoperative nausea and vertigo after discharge in outpatient ear surgery.

Administration, Cutaneous↗
PubMed2001

Development of patches for the controlled release of dehydroepiandrosterone.

Dehydroepiandrosterone (DHEA) and its sulfate conjugate (DHEAS) are the major secretory steroidal products of the adrenal gland. Some epidemiologic studies have found an association between low DHEA serum levels in patients and many important diseases. To prevent all such pathological conditions and, in any case, in aging, a DHEA supplementation has been proposed. DHEA shows a low oral bioavailability; taking the bioavailability obtained by the subcutaneous route as 100%, it was estimated that the potencies of DHEA by the percutaneous and oral routes were approximately 33% and 3%, respectively. Thus, transdermal patches could be considered a promising formulation as a continuous and controlled delivery of DHEA in replacement therapy is desired. With the aim of evaluating the effect of the matrix composition in terms of polymers and enhancers on the DHEA skin permeation flux, 10 types of monolayer self-adhesive patches containing 0.25mg/cm2 of active ingredient were designed. The matrices were based on three different acrylic copolymers: an acrylate-vinylacetate copolymer, a polyaminomethylmethacrylate (PAMA), and a polymethylmethacrylate. Transcutol (TR), mint essential oil, Lauroglycol, Brij 58, and propylene glycol (PG) were evaluated as DHEA skin permeation enhancers. All prepared patches were characterized by drug content, light microscopy, and in vitro skin permeation, performed using a modified Franz-type diffusion cell and human stratum corneum and epidermis as a membrane. The in vitro skin permeation studies are particularly significant in the development studies of DHEA patches as the in vivo determination of DHEA is affected b the fact that the endogen substance in the plasma is not constant over time. Among the testedpatches, highest DHEA fluxes were obtained using the formulation based on PAMA. Moreover, the introduction in the matrix of binary mixtures of TR and PG, used also for their plasticizer properties, permitted enhancing DHEA skin permeation. On the basis of these studies, the transdermal administration of DHEA using patches seems feasible.

Administration, Cutaneous↗
PubMedDate not supplied

Drug release rates from four sizes of a new transdermal nitroglycerin adhesive patch.

This study was conducted to determine the amount of nitroglycerin released from transdermal nitroglycerin patches of four different sizes: 3.3 cm2, 6.7 cm2, 13.3 cm2, and 20 cm2. Thirty healthy men received a single 24-hour application of each patch size according to a randomized, open-label, four-period crossover design. A 24-hour interval separated each treatment period. The total amount of nitroglycerin released by the four patches was proportional to size. All four patch sizes released nitroglycerin at a comparable rate. The mean overall 24-hour release rate of 0.76 mg/cm2 was similar to the release rate of 0.75 mg/cm2/24 hr observed in a previous study. Adverse experiences common to nitroglycerin administration were reported for all patch sizes, with headache, light-headedness, and nausea reported most frequently.

Administration, Cutaneous↗
PubMed1998

The therapeutic potential of testosterone patches.

In the last decade, transdermal delivery of testosterone (T) has been shown to be a safe and effective means of treating male hypogonadism. Transdermal T patches can provide for physiologic androgen replacement in over 90% of men with hypogonadism. In addition, T patches have been shown to be equivalent to im. T esters in restoring normal male libido,sexual function and bone mineral density without harmful side-effects.Furthermore, in sharp contrast to periodic im. injections of T, transdermal T patches, when used daily, restore the normal circadian rhythm of T levels. The physiological and clinical importance of these circadian patterns,however, is presently unknown. The first transdermal patch to be marketed is applied to shaved scrotal skin. Newer patches can be applied to non-scrotal skin; however, these patches are associated with a significant rate of skin reactions that may require discontinuation. The main drawback to transdermal T delivery is cost, ten to twenty times the monthly cost of im. T, the method currently used to treat most hypogonadal men.Nevertheless, transdermal T patches constitute a major advance in the therapy of male hypogonadism as they allow for safe, non-invasive administration of T.

Journal Article↗
PubMedDate not supplied

Relationships between sensation seeking and emotional symptomatology during smoking cessation with nicotine patch therapy.

This study explored relationships between the sensation-seeking trait and the development of emotional symptomatology during smoking cessation with nicotine transdermal patches. Twenty-five subjects were evaluated before they stopped smoking, on Day 8, Day 30, Day 90, and Day 120. Initial motives for smoking and the sensation-seeking personality trait were tested as possible predictors for the development of specific mood disturbances. Our subjects scored very high on sensation seeking, consistent with previous results on smokers. This may also be due to the well-known tendency of high sensation-seekers to be willing to try new experiences. The sensation-seeking trait did not predict the issue of cessation. However, it was related to emotional deficit (anhedonia, affective blunting), tiredness, and a lack of energy, before and during smoking cessation. Two different interpretations of emotional deficit are proposed.

Administration, Cutaneous↗
PubMed2003

Telephone counselling as an adjunct to nicotine patches in smoking cessation: a randomised controlled trial.

OBJECTIVES: To investigate the effectiveness of telephone counselling as an adjunct to nicotine replacement therapy (NRT) by transdermal patch in smoking cessation. DESIGN: Randomised controlled trial. PARTICIPANTS AND SETTING: 854 smokers from New South Wales, aged 18 years and older, who had smoked at least 10 cigarettes per day for the past year and responded to newspaper advertisements between October 2001 and January 2002; the trial was conducted between October 2001 and August 2002. INTERVENTIONS: Random allocation to either NRT alone or NRT plus telephone counselling (5 sessions spaced according to a relapse-sensitive call schedule). MAIN OUTCOME MEASURES: Self-reported abstinence assessed by telephone questionnaires at 1, 2, 3 and 6 months: 28-day continuous abstinence at 3 and 6 months, and 90-day continuous abstinence at 6 months. RESULTS: 28-day continuous abstinence rates among participants receiving telephone counselling were significantly greater than among those not receiving telephone counselling at both 3 and 6 months (31.6% v 25.1%; P = 0.04 at 3 months; and 30.1% v 22.4%; P = 0.01 at 6 months). Similarly, 90-day continuous abstinence rates at 6 months were significantly greater for participants receiving counselling (26.7% v 18.6%; P = 0.004). CONCLUSION: Telephone counselling as an adjunct to NRT increases abstinence rates beyond the use of NRT alone.

Administration, Cutaneous↗
PubMedDate not supplied

Topical diclofenac patch for postoperative wound pain in laparoscopic gynecologic surgery: a randomized study.

STUDY OBJECTIVE: To compare pain management of standard analgesic and standard analgesic plus diclofenac transdermal patch in patients who undergo laparoscopic gynecologic surgery. DESIGN: Randomized prospective study (Canadian Task Force classification I). SETTING: University hospital. PATIENTS: One hundred twenty patients requiring laparoscopic surgery for gynecologic benign diseases. INTERVENTIONS: Patients were divided into two groups, one medicated with a diclofenac patch (diclofenac group) and the other medicated with standard skin medication (placebo; control group) at all incisional areas at the end of the operation. MEASUREMENTS AND MAIN RESULTS: The principal measures of outcome were pain intensity at 6, 12, and 24 hours after surgery and consumption of analgesics. The two treatment groups were comparable with respect to demographic and intraoperative characteristics. No significant difference was observed between the two groups in mean pain intensity at 6 hours after surgery. Mean pain intensity at 12 and 24 hours, respectively, after surgery was significantly lower in the diclofenac group (3.7 +/- 1.3 and 2.0 +/- 0.6) than that observed in the control group (5.7 +/- 1.9 and 4.6 +/- 0.5) (p value, respectively, .002 and <.001). Twenty-one patients (35.0%) in the diclofenac group required analgesics in the first 36 hours after the operation versus 43 patients (71.7%) in the control group (p <.001). Hospital discharge was significantly more rapid in the diclofenac group (28 +/- 5 hours vs 39 +/- 3 hours; p = .031). CONCLUSION: Diclofenac transdermal administration seems a valid help to standard analgesic treatment in postoperative pain control and could also help reduce the period of hospitalization of patients who undergo laparoscopic benign gynecologic surgery.

Administration, Topical↗
PubMed1999

Current hormone replacement therapy: what are the shortcomings? Advances in delivery.

The introduction of transdermal and other parenteral delivery systems has broadened the range of options for hormone replacement therapy (HRT). Oral oestrogen is the most common initial therapy; however, direct absorption of oestradiol via the skin results in an oestradiol-oestrone ratio similar to that found in the pre-menopausal state. Both oral and transdermal oestrogen therapy have been shown to be equally effective in relieving climacteric symptoms, and in preventing osteoporosis or modifying some cardiovascular disease risk factors, although transdermal therapy tends to have fewer unwanted effects than oral. Satisfactory circulating oestradiol levels are achieved with skin patches, transdermal gel, or crystalloid oestradiol implants, and adding progestogen to protect the endometrium is well established. Sequential therapy with HRT usually produces a regular bleed, which is a major cause of patient dissatisfaction. The ideal HRT regimen is probably unobtainable, but the development of SERMs and other regimens that avoid bleeding will encourage long-term use.

Administration, Cutaneous↗
PubMed2005

Pharmacology of estrogens and progestogens: influence of different routes of administration.

This review comprises the pharmacokinetics and pharmacodynamics of natural and synthetic estrogens and progestogens used in contraception and therapy, with special consideration of hormone replacement therapy. The paper describes the mechanisms of action, the relation between structure and hormonal activity, differences in hormonal pattern and potency, peculiarities in the properties of certain steroids, tissue-specific effects, and the metabolism of the available estrogens and progestogens. The influence of the route of administration on pharmacokinetics, hormonal activity and metabolism is presented, and the effects of oral and transdermal treatment with estrogens on tissues, clinical and serum parameters are compared. The effects of oral, transdermal (patch and gel), intranasal, sublingual, buccal, vaginal, subcutaneous and intramuscular administration of estrogens, as well as of oral, vaginal, transdermal, intranasal, buccal, intramuscular and intrauterine application of progestogens are discussed. The various types of progestogens, their receptor interaction, hormonal pattern and the hormonal activity of certain metabolites are described in detail. The structural formulae, serum concentrations, binding affinities to steroid receptors and serum binding globulins, and the relative potencies of the available estrogens and progestins are presented. Differences in the tissue-specific effects of the various compounds and regimens and their potential implications with the risks and benefits of hormone replacement therapy are discussed.

Drug Administration Routes↗
PubMed2002

Efficacy of a new 7-day transdermal sequential estradiol/levonorgestrel patch in women.

OBJECTIVE: To investigate the efficacy and tolerability of a new 7-day transdermal sequential estradiol/levonorgestrel patch (Fem7 Combi; Merck KGaA; Germany), versus placebo, as hormone replacement therapy in menopausal women. METHODS: A multicentre, randomized, clinical study consisting of a 3-week screening phase, a 12-week double-blind, placebo-controlled treatment phase, and a 12-week open, follow-up phase. Women aged 40-65 years with an intact uterus and menopausal complaints were randomized to either 2 weeks of an estradiol mono patch (50 microg per 24 h) followed by 2 weeks of an estradiol/levonorgestrel combination patch (50 microg/10 microg per 24 h), or a placebo patch, for three 28-day cycles. Changes in the Kupperman Index and the frequency of hot flushes were assessed. RESULTS: The sequential use of a 7-day estradiol patch and a 7-day estradiol/levonorgestrel patch was superior to placebo in reducing menopausal symptoms, and was well tolerated. At the end of the treatment phase, there was a statistically significant reduction in the Kupperman Index score versus placebo (P<0.0001), and a statistically significant difference between groups in the proportion of patients with a reduction in the number of hot flushes (at least 50% versus baseline). During the open follow-up phase, there was a marked reduction in the Kupperman Index score and the number of hot flushes for patients switched from placebo to active study medication. The active medication was effective throughout the 1-week application period. CONCLUSIONS: The new 7-day transdermal sequential estradiol/levonorgestrel patch was well tolerated, providing rapid and effective relief of menopausal symptoms. The addition of low-dose levonorgestrel did not influence the beneficial effects of estradiol.

Administration, Cutaneous↗
PubMed1999

Oral versus transdermal selegiline: antidepressant-like activity in rats.

These studies compared the dose-response effects of oral vs. transdermal selegiline on antidepressant-like activity and brain monoamine oxidase (MAO) activities in rats. Rats received selegiline by gavage (0-100 mg/kg) or via transdermal patches (0-4.8 cm2, 0-8.7 mg/kg) daily for 7 days; antidepressant-like activity was determined using the forced-swim test. Following behavioral testing, cerebral cortices were assayed for MAO-A and MAO-B activities. Doses of selegiline that selectively inhibited MAO-B (3 and 10 mg/kg/day by gavage and 0.4 mg/kg/day via patch) did not alter either immobility or latency time. However, the oral administration of 30 or 100 mg/kg/day or the transdermal administration of 8.7 mg/kg/day, doses that led to greater than 70% inhibition of MAO-A, decreased immobility time significantly. The IC50s for inhibition of MAO-A following oral and transdermal administration for 7 days were 19.8 and 1.1 mg/kg, respectively. Results indicate that both oral and transdermal selegiline have antidepressant-like activity as assessed by the forced-swim test, and that transdermal administration, which bypasses first-pass metabolism, allows for using lower doses than oral administration.

Administration, Cutaneous↗
PubMed1996

Fentanyl patches left on dead bodies -- potential source of drug for abusers.

We report a fatal case of fentanyl poisoning in which the decedent apparently obtained the drug from a used transdermal patch removed from a deceased nursing home patient. Fentanyl drug patches, even those previously used, contain a potentially lethal amount of this potent narcotic analgesic and provide a source of fentanyl for drug abusers. This case demonstrates the importance of proper disposal of these drug patches and the need for strict policies and guidelines in patient care settings regarding their disposal. Since fentanyl derivatives may not be detected on routine toxicologic analysis, specific assays should be utilized for the detection of fentanyl in cases of suspected drug overdose.

Administration, Cutaneous↗
PubMed1994

Dose-dependent effects of transdermal nicotine on early morning awakening and rapid eye movement sleep time in nonsmoking normal volunteers.

The dose-dependent, acute effects of transdermal nicotine (7 and 14 mg) and placebo, applied 2 hours before bedtime, on sleep and mood were determined in 12 nonsmoking normal volunteers. Compared with placebo patch, transdermal nicotine was associated with early morning awakening and reduced total rapid eye movement (REM) sleep time and REM% in a dose-dependent fashion. On the recovery night after the administration of an active nicotine patch, REM latency and stage 2% were significantly reduced, whereas REM sleep time and REM% increased compared with the active patch. Mood and subjective recall of dreaming were not significantly affected in this study. Although one subject vomited about 10.5 hours after the 14-mg dose, reported side effects were generally mild.

Administration, Cutaneous↗
PubMed2002

Intestinal patches for oral drug delivery.

PURPOSE: Oral route offers an attractive mode of drug administration, although its applications are limited by poor stability of peptides and proteins in the gastrointestinal tract. In this article, we report a novel method based on intestinal patches for oral drug delivery. This method involves the use of millimeter size mucoadhesive patches that adhere to the intestinal wall and direct solute diffusion towards the wall similar to that observed in the case of a transdermal patch. METHODS: Intestinal patches were prepared by sandwiching a film of cross-linked bovine serum albumin microspheres between a film of ethyl cellulose and Carbopol/pectin. Delivery of three model drugs, sulforhodamine B. phenol red, and dextran was assessed in vitro using rat intestine. RESULTS: In vitro tests confirmed substantial unidirectional diffusion of model drugs from the patch across the intestinal wall. The presence of ethyl cellulose layer minimized release from the edges as well as from the back side of the patch into the intestinal lumen. In vitro experiments with rat intestine showed that patches were effective in delivering model drugs across the intestine. Trans-lumenal flux of model drugs from intestinal patches was about 100-fold higher compared to that from a solution due to localization of the solute near the intestinal wall and due to minimization of drug loss into the intestinal lumen. CONCLUSIONS: Intestinal patches offer a novel approach for oral drug delivery.

Adhesives↗
PubMed1998

Double-blind placebo controlled trial of dextrose tablets and nicotine patch in smoking cessation.

In a placebo-controlled double-blind trial 308 smokers were individually randomly allocated to one of four groups: 1) 3 g dextrose tablets and 15 mg nicotine transdermal patch; 2) dextrose and placebo patch; 3) placebo tablets and nicotine patch; 4) placebo tablets and placebo patch. Patients were scheduled to attend weekly smokers clinic sessions starting 1 week before the quit date and continue for 4 weeks after that date. The primary outcome variable was biochemically verified abstinence at the final session, four weeks after the scheduled quit date. The proportion of smokers abstinent in the four groups was as follows: 49% - dextrose plus active patch; 44% - dextrose plus placebo patch; 36% - placebo tablet plus active patch; 30% - placebo tablet plus placebo patch. The difference between the dextrose and placebo tablets (13%) was statistically significant (P < 0.01, one-tailed); the difference between the active and placebo patches (6%) was not. There was no significant difference between the effect of the dextrose when accompanied by active versus placebo patches. There was no significant effect of dextrose on weight. The results suggest that dextrose supplementation to the diet may be a cheap and simple aid to giving up smoking. Further research is now needed to establish its long-term efficacy.

Adolescent↗
PubMed1999

Effects of nicotine administered via a transdermal delivery system on vigilance: a repeated measure study.

Fifteen 18- to 25-year-old male smokers were tested in a within-subjects design to determine the influence of a transdermal patch of 21 mg nicotine on vigilance. Subjects were tested on the RVIP test (Rapid Visual Information Processing test) 1.30, 3.00 and 6.30 h after patch application, to verify the involvement of the dose of nicotine on the performance. This study confirms and extends the increasing effects of nicotine on vigilance previously found with orally and transdermally given nicotine. Moreover, it showed that such performance was independent of the time of nicotine absorption (1.30, 3.00 and 6.30 h after patch application), which suggests that a relatively low dose of nicotine suffices to activate vigilance processing. Regarding motor performance, no convincing effect of nicotine was observed on reaction time.

Administration, Cutaneous↗