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PubMed1998

HPLC evaluation of drugs in transdermal therapeutic preparations. I. Glycerol trinitrate.

In connection with the development of transdermal delivery systems (TTS) of the laminated adhesive patches type, HPLC was selected for analytical evaluation of active principles. It was employed for analysis of glycerol trinitrate (GTN) as one of the drugs administered in the form of medicinal adhesive patches. After isolation from the patch, GTN was analysed by reverse phase HPLC, employing methanol and water as the mobile phase, and detected at 206 nm. The total amount of GTN in the patch was evaluated and its concentrations in a lactose trituration and the reservoir layer were determined. In the patches manufactured in a test series, the elaborated HPLC method was used to investigate the release of GTN in a liberation study and its permeation through excised human skin in experiments performed in vitro. In connection with the stability study, the decomposition products of GTN were also determined.

Administration, Cutaneous↗
PubMed2005

Effects of transdermal nicotine during imaginal exposure to anxiety and smoking cues in college smokers.

In a 2 (patch) x 2 (smoking) x 2 (anxiety) mixed design, 52 undergraduate smokers randomly received a nicotine (21 mg) or placebo patch. After a 4-hr nicotine absorption/deprivation period, participants imagined several scenarios varying in cue content: (a) anxiety plus smoking, (b) anxiety, (c) smoking, and (d) neutral. Although smoking urge increased in both the nicotine and placebo conditions after the absorption/deprivation period, those who received the placebo reported significantly greater urge. During the cue reactivity trials, a significant Patch x Smoking x Anxiety interaction effect was observed for urge. However, participants who received nicotine still experienced moderate urges, indicating that nicotine did not attenuate cue-elicited urge. Transdermal nicotine did not diminish anxiety during the absorption/deprivation period or in response to the cues.

Administration, Cutaneous↗
PubMed2005

Adolescents' experience with the combined estrogen and progestin transdermal contraceptive method Ortho Evra.

BACKGROUND: The new combined estrogen & progestin contraceptive patch Ortho Evra was approved by the FDA in December 2001. To date, there is a paucity of data regarding its use in the adolescent age group. We examined adolescents' experience with this new contraceptive method. METHODS: Using a questionnaire designed by the authors, care providers in a hospital based adolescent clinic interviewed and reviewed the charts of adolescent girls who had initiated Ortho Evra in 2002-2003. RESULTS: Twenty-eight adolescent girls (age 18 +/- 1 years, gyn age 6 +/- 1 years, onset of sexual intercourse at 14 +/- 1 years, body mass index (BMI) 27.6 +/- 1.2, 57% Hispanic, 21% Caucasian, 11% African American, 7% biracial, 4% Indian American) who had used Ortho Evra for 7 +/- 1 months were enrolled. Half (50%) were adolescent mothers, and 57% had a history of irregular menstrual periods. All (100%) girls reported regular menstrual periods while using Ortho Evra, with only 14% experiencing occasional breakthrough bleeding. Half reported a shorter duration and 36% reported a lighter flow of their periods. About a third (39%) reported a decrease and 11% reported an increase in dysmenorrhea symptoms. About a third (29%) of those with a history of recurrent headaches at initiation reported decrease in headaches, and about a third (33%) of those with acne at initiation reported decrease in facial acne while on Ortho Evra. There were no significant BMI changes during Ortho Evra use. Although condom use while on Ortho Evra was poor (only 15% reporting consistent condom use), there were no pregnancies reported. A majority (93%) reported that they remembered to apply the patches on time, and 40% stated that Ortho Evra was easier than previous contraceptive methods. Two thirds (68%) were very satisfied and 29% were somewhat satisfied with the method, and 93% stated that they would recommend the method to a friend/relative. The preferred application site was the buttock (40%) followed by the lower abdomen (32%). About a fifth (21%) experienced at least one episode of complete patch detachment and 32% reported partial peeling of the patch corners. About a third (32%) would prefer another patch color, and 25% would like a fourth week placebo patch. The most common side effects were mild temporary application site reactions (64%), some discomfort on patch removal (32%), nausea (18%), and breast tenderness (18%). Eleven girls (39%) discontinued Ortho Evra (three lost health insurance, three because of application site reactions, two found patch application schedule difficult to remember, two desired pregnancy, two because of nausea, one because of perceived weight gain). CONCLUSIONS: Ortho Evra provides excellent cycle control in adolescents. Most adolescents are satisfied with this method. Intensive efforts should be made to increase condom use by adolescents on Ortho Evra.

Abdomen↗
PubMed1998

[Nitroglycerin patches: properties and norms for correct use].

The frequent application of Nitroglycerin Transdermal Systems in patients who need a prophylaxis of anginal episodes requires that medical section should know to use them and their pharmacological properties. These knowledges about their application should be explained to patients and their relatives clear and concisely for them to achieve an accurate use. Having checked the required bibliography, I want to show in this article both the characteristics of this pharmacological preparation and some important points about educational process that patients and relatives should follow: at the same time, this article tries to answer all the questions which might arise.

Administration, Cutaneous↗
PubMed2004

Use of transdermal fentanyl without prior opioid stabilization in patients with cancer pain.

OBJECTIVE: To determine the safety and efficacy of transdermal fentanyl for pain relief in cancer patients and to compare the effects on patients according to whether they had previously received strong opioids, weak opioids or non-opioid analgesia. METHODS: Cancer patients requiring strong analgesia were recruited into an open-label, multicentre study, conducted in eight countries. Patients received transdermal fentanyl treatment for 28 days. Pain severity, overall satisfaction with pain control, convenience of use of patches and treatment preferences were recorded daily. RESULTS: Of the 292 participants, 135 had previously received a strong opioid, 84 had previously received a weak opioid and 73 had received no regular opioids. Thirty-eight patients did not complete the study, mainly due to adverse events. For all groups the proportion of patients with 'good to excellent' pain control increased after transdermal fentanyl treatment. Transdermal fentanyl was well tolerated, with the most common treatment-related adverse events being nausea, vomiting and constipation. The percentage of strong-opioid-tolerant patients with constipation decreased following transdermal fentanyl treatment and increased slightly in the strong-opioid-naïve groups. Most patients rated the convenience of the patches as 'good to excellent', and most preferred transdermal fentanyl to their previous therapy. CONCLUSIONS: Transdermal fentanyl is an effective and well-tolerated treatment for cancer-related pain for patients regardless of whether they have previously received opioids. Previous guidelines have often advocated initial dose finding with short-acting opioids but this study demonstrates that such a complex titration and conversion schedule may not be necessary,and that treatment may be initiated directly with long-acting formulations such as transdermal fentanyl when previous analgesic therapy fails to provide adequate relief.

Administration, Cutaneous↗
PubMed1999

Evaluation of adhesive properties of patches based on acrylic matrices.

Adhesion is an essential property of the dermal and transdermal therapeutic systems (TS). It is influenced by the composition and the thickness of the matrix and also by the characteristics of the backing layer. Our aim was to evaluate the usefulness of the "thumb tack test," the "tack rolling ball test," and the "peel adhesion 180 degrees test" in the development studies and quality control of TS. These tests were performed on two series of placebo patches in which the backing layer was made of artificial silk (series 1) and polyurethane film (series 2). The patches of both series were prepared using five different mixtures of a hydrophilic adhesive copolymer and a hydrophobic nonadhesive copolymer as matrices. Plastoid E 35 L, a copolymer of dimethylaminoethyl methacrylate and neutral methacrylic esters, was used as the adhesive polymer. Eudragit NE 40 D, a copolymer of ethylacrylate and methylmethacrylate, was used as the nonadhesive copolymer. In the standard procedure for the peel adhesion 180 degrees test, used in the tape industries, the adherent is made of stainless steel. Because the latter has a high surface energy, it was not suitable for the analysis of the patches with a polyurethane backing layer. Therefore, the critical surface tension of five alternative materials (rubber, polysiloxane, polyethylene, nylon, polyvinyl chloride) was evaluated. Polyethylene was selected for the modified peel adhesion 180 degrees test, and better results were obtained in terms of feasibility of the test and ability to discriminate between the different patches prepared.

Acrylates↗
PubMed1997

Transdermal fentanyl. A review of its pharmacological properties and therapeutic efficacy in pain control.

Fentanyl is a synthetic opioid with short-acting analgesic activity after intravenous or subcutaneous administration. The low molecular weight, high potency and lipid solubility of fentanyl make it suitable for delivery via the transdermal therapeutic system (TTS). These systems are designed to release the drug into the skin at a constant rate ranging from 25 to 100 micrograms/h, multiple systems can be applied to achieve higher delivery rates. Initially, much of the clinical experience with fentanyl TTS was obtained in patients with acute postoperative pain. However, because of the increased risk of respiratory complications, fentanyl TTS is contraindicated in this setting. Fentanyl TTS is recommended for use in chronic cancer pain. Moreover, in 11 countries worldwide including the US, its use is not restricted to chronic cancer pain; the drug is also available for treatment of general chronic pain, including that of nonmalignant origin. At the start of fentanyl TTS treatment, depot accumulation of the drug within skin tissue results in a significant delay (17 to 48 hours) before maximum plasma concentration is achieved. Approximately half of the cancer patients converted to transdermal fentanyl from other opioid agents required increased dosages after initial application of the patch. However, concomitant use of short-acting morphine maintained pain relief during the titration period, and the use of such supplementary medication decreased with the duration of fentanyl TTS treatment. In patients with chronic cancer pain, changes in visual analogue scale (VAS) pain scores ranged from a 10% increase (worse pain) to > 50% decrease (less pain) during transdermal fentanyl therapy compared with previous opioid treatment. In addition, patient preference for fentanyl TTS was indicated by the number of patient requests (up to 95%) for continued use of the drug at the end of the study. Although fentanyl TTS is contraindicated in patients postoperatively, the efficacy of fentanyl via the transdermal route was investigated in this patient group. Supplementary patient controlled analgesia was significantly reduced in patients who received fentanyl TTS 75 micrograms/h compared with placebo, although this was not apparent until > or = 12 hours after application. Data evaluating pain relief, which was assessed by VAS pain scores, were inconclusive. Preliminary data, although from relatively small numbers of patients, indicate that transdermal fentanyl may be useful in the management of chronic non-malignant pain. Indeed, some patients whose pain was previously uncontrolled became completely pain free. The most frequently occurring adverse events during fentanyl TTS therapy (as with other opioid agents) included vomiting, nausea and constipation, although vomiting and nausea were not clearly associated with the drug. The most serious adverse event was hypoventilation, which occurred more frequently in postoperative (4%) than in cancer patients (2%). In surgical patients, fentanyl-associated respiratory events (reduced respiratory rate and apnoea) generally occurred within 24 hours of patch application; however, there were isolated reports of late onset (> or = 36 hours postsurgery) fentanyl-associated respiratory depression. In cancer patients, the incidence of constipation was reduced by up to two-thirds after switching from oral morphine to transdermal fentanyl. Transient skin irritation associated with the plastic patch or the adhesive, rather than the drug, was reported in a maximum 3% of patients. In summary, transdermal fentanyl is a useful alternative to other opioid agents, which are also recommended on the third step of the WHO analgesic ladder, in the management of chronic malignant pain. Preliminary data indicate that it may be useful in the management of chronic nonmalignant pain. The advantages offered by fentanyl TTS over traditional methods of chronic pain control include its ease of administration, less constipation and the 3-

Analgesics, Opioid↗
PubMed1998

Bioequivalence assessment of a single 5 mg/day testosterone transdermal system versus two 2.5 mg/day systems in hypogonadal men.

A novel, nonscrotal, transdermal delivery system for testosterone therapy has been marketed for treatment of hypogonadal men. The usual dose of this system is two 2.5 mg/day systems applied daily. A new system has been developed that administers a dose of 5 mg/day using a single patch rather than two patches. A randomized, steady-state, four-period, replicate-design, open-label, crossover study was conducted to assess the bioequivalence of the two testosterone transdermal delivery systems in postpubertal, hypogonadal men: two 2.5 mg/day patches as the reference regimen (R) and one 5 mg/day patch as the test regimen (T). 21 men were enrolled, and 20 completed the study. Each subject was randomly assigned to one of four sequences (R1-R2-T1-T2, T1-T2-R1-R2, R1-T1-T2-R2, T1-R1-R2-T2), such that each subject received each regimen during two study sessions. Two subjects were inadvertently treated according to the sequence T1-R1-T2-R2. Patches were applied to the upper arm, thigh, and back in the evening on days 1, 2, and 3, respectively, of each study session. Serial blood samples were obtained for pharmacokinetic analysis of testosterone for 24 hours after patch application on day 3 of each study session. The two formulations would be considered bioequivalent if the 90% confidence intervals (CI) for the ratios of the adjusted geometric means for T:R for both area under the concentration--time curve from 0 to 24 hours (AUC0-24) and maximum concentration (Cmax) were completely contained in the interval (0.80, 1.25). Mean values for AUC0-24 and Cmax were similar for the two formulations. The T and R formulations were found to be bioequivalent based on both AUC0-24 (90% CI 0.96, 1.08) and Cmax (90% CI 0.92, 1.07). The median time to Cmax was also similar, indicating comparable rates of testosterone absorption for both formulations. Based on this analysis, the testosterone transdermal system 5 mg/day patch is bioequivalent to two of the 2.5 mg/day patches. Both systems were safe and well tolerated in hypogonadal men.

Administration, Cutaneous↗
PubMed2001

Effects of surgical menopause and estrogen replacement therapy on atrio-ventricular conduction and ventricular repolarization.

OBJECTIVE: To evaluate the effect of surgical menopause and estrogen replacement therapy on atrio-ventricular conduction and ventricular repolarization in women. METHODS: In a prospective, randomized, double-blind, placebo-controlled clinical trial 50 women underwent hystero-salpingo-oophorectomy. Twenty-five women were treated with 50 microg/die of transdermal estradiol and the other 25 were treated with placebo patches. The duration of the treatment was 12 cycles. Before surgery and after 12 cycles of treatment, a standard electrocardiogram was performed to evaluate atrio-ventricular conduction time and cardiac repolarization time. RESULTS: No significant variations in atrio-ventricuar conduction time and cardiac repolarization time were detected between the two groups at entry, nor was there any difference in both groups after 12 cycles of treatment with transdermal estradiol. CONCLUSIONS: Surgical menopause and estrogen replacement therapy do not modify atrio-ventricular conduction and ventricular repolarization in women.

Adult↗
PubMed1990

Scopolamine withdrawal syndrome.

As travel by air and ship becomes increasingly popular, more and more travelers are using transdermal scopolamine to avoid motion sickness. In fact, it has become almost fashionable for ocean travelers to sit on the sun deck with a patch behind the ear. This article describes withdrawal symptoms in a patient who used transdermal scopolamine beyond the recommended 3 days.

Administration, Cutaneous↗
PubMedDate not supplied

[Nitroglycerin patch for tocolysis--a prospective randomized comparison with fenoterol by infusion].

OBJECTIVE: To evaluate tocolytic efficacy of transdermal glyceryl trinitrate (GTN) in comparison to fenoterol per infusionem in a prospective randomized multicenter study. PATIENTS AND METHODS: 50 pregnant women between 27 and 35 weeks of gestation with preterm labour were treated with either GTN patches (0.4-0.8 mg/h) or fenoterol per infusionem (60-120 micrograms/h) up to stop of contractions or 35 weeks in maximum. The primary outcomes were the prolongation of gestation by 48 h, 7 days or up to 37 weeks of gestation as well as the neonatal outcome. The progression of cervical ripening and maternal side effects during tocolysis were assessed as secondary outcome criteria. RESULTS: There was no difference in successful tocolysis for 48 h and 7 days in both groups, whereas significantly more women passed 37 weeks after GTN therapy. So mean duration of pregnancy, birth weight and height were greater, whereas transfer into neonatal care unit was significantly rare after GTN. There were no differences in neonatal outcome and progression of cervical ripening during tocolysis. Maternal side effects during GTN were fewer and weaker compared with fenoterol. Circa 70% of GTN treated women had a headache temporary, whereas more than 90% of the patients with fenoterol suffered from tachycardia and tremor. CONCLUSIONS: Tocolytic efficacy of transdermal GTN was at least equivalent to the established beta-mimetic therapy with fenoterol. Because of the lower preterm delivery rate transfer into neonatal care for control was significantly rarer after GTN with equally good neonatal outcome in both groups. Beside the headache transdermal GTN therapy had lower maternal side effects in comparison to fenoterol.

Administration, Cutaneous↗
PubMed1993

Effectiveness of nicotine patch and nicotine gum as individual versus combined treatments for tobacco withdrawal symptoms.

Nicotine gum and transdermal nicotine have been shown to relieve withdrawal and double success rates over placebo in trials of smoking cessation. This study tested whether combining the two methods would relieve withdrawal more effectively compared to either treatment alone. Twenty-eight smokers served as their own controls in each of four conditions: active gum + active patch (double active), active gum + placebo patch (gum only active), placebo gum + active patch (patch active) and placebo gum + placebo patch (double placebo). This "double placebo" design controls sensory, psychological and ritual variables associated with each drug form. Withdrawal symptoms were rated four times daily for 3 days in each condition. Total baseline (smoking) withdrawal scores using visual analogue scales (VAS) averaged 101.1. During cessation, total withdrawal increased to 187.0 for the double placebo condition, 142.2 for the active gum/placebo patch treatment and 128.3 for the active patch/placebo gum treatment. The double active condition equalled smoking with score 99.2. All pairwise comparisons were significant (P < 0.001) except between the two single active conditions and between smoking versus the double active condition. Significant time-of-day effects by treatment on withdrawal were observed for the double placebo condition (P < 0.05) with less withdrawal in the morning. The findings suggest: 1) combining nicotine gum with transdermal nicotine may be superior to either treatment alone, 2) more symptoms may be nicotine specific (relieved by replacement) than previously thought.

Administration, Cutaneous↗
PubMed2002

Behavioral pharmacology of buprenorphine, with a focus on preclinical models of reward and addiction.

RATIONALE: Buprenorphine is a potent mu-receptor partial agonist and is widely used as an analgesic drug. It is also increasingly considered to be an alternative to methadone in the maintenance and eventual detoxification of heroin addicts, and also in the treatment of cocaine addiction. So far, buprenorphine has been available as a sublingual tablet and as a solution for IV injection. Recently, a new transdermal formulation of buprenorphine in slow-release matrix patches has been introduced (Transtec) for the treatment of intermediate to severe pain. OBJECTIVES: The aim of this paper is to review, from a preclinical perspective, the current status of what is known about the behavioral pharmacology of buprenorphine, with a particular emphasis on the issues of reward, addiction, and dependence. It will also point to open questions that should be addressed in the future to improve our understanding of the effects and the mechanisms of action of this drug. RESULTS AND CONCLUSIONS: Since buprenorphine is a potent opioid drug, the issue of addiction and dependence in this context is an important one. Although there are still some gaps in the behavioral pharmacological characterization of buprenorphine, the general conclusion that can be drawn from the reviewed literature is that despite the high affinity of buprenorphine for the mu receptor it appears to be a remarkably safe drug, with a benign overall side effect profile and low addictive and dependence-inducing potential. This favorable side effect profile appears to be due, to a large extent, to the partial agonistic properties of the drug, in combination with its particular receptor kinetics (i.e. very slow dissociation from the mu receptor after binding).

Analgesics, Opioid↗
PubMed2002

Short-term suppression of ovarian function and immune measures in healthy women.

Ovarian function was suppressed to postmenopausal levels with a GnRH agonist for four months in healthy, premenopausal women to examine the effect of short-term alterations in sex steroid exposure on immune measures at rest and in response to standardized laboratory stressors. Twenty-two women were assessed at three times: (a) during the early follicular phase of the menstrual cycle; (b) after ovarian function had been suppressed by a GnRH agonist; and (c) either in the early follicular phase after the resumption of regular menstrual cycling (group labeled Cycle), or when women received estradiol transdermally in conjunction with a GnRH agonist (group labeled Patch). A third group of 11 women was assessed at similar time points, but in a different order of pharmacologic intervention to evaluate the effects of ovarian function suppression that were not confounded by habituation to the laboratory stressors (group labeled Hormone Control). Finally, 15 women served as control subjects to control for the effects of time, seasonality and blood collection procedures on immune measures (group labeled Immune Control). Immune measures included circulating cell counts, response to mitogens (PHA and PWM), and NK cytotoxicity. Results revealed no consistent changes in basal or stress-induced immune measures that varied with a period of short-term suppression of ovarian function. Basal and acute stress-induced cell counts showed moderate to high temporal stability over a six to ten month time interval.

Adult↗
PubMed2002

Gender-related differences in erythrocyte glutathione peroxidase activity in healthy subjects.

OBJECTIVE: The antioxidant property of oestrogens may partly explain the gender differences in atherosclerotic heart disease and a reduction in the incidence of coronary heart disease, as well as mortality from cardiovascular disease in women undergoing postmenopausal oestrogen therapy. In the present study, we tested the hypothesis that the antioxidant glutathione peroxidase (GSH-Px) erythrocyte activity is gender related and is correlated with oestradiol serum levels. PATIENTS: One hundred and fifty healthy women (90 premenopausal; 60 postmenopausal) and 150 age-matched healthy men were recruited during routine health screening. DESIGN AND MEASUREMENTS: Serum was analysed for oestradiol (E2), progesterone and testosterone concentrations, and erythrocytes for GSH-Px enzyme activity. Thirty of the 60 postmenopausal women were treated with transdermal therapy for 30 days with 8-mg E2 patches (nominal daily dose 100 micro g), while the remaining 30 acted as controls. RESULTS: Erythrocyte GSH-Px activity was significantly higher in premenopausal than in postmenopausal women (P = 0.0014), and higher in premenopausal women than in age-matched men (P = 0.025). By contrast, no significant differences were observed between postmenopausal women and the age-matched male population. In postmenopausal women, E2 replacement therapy induced a significant increase in erythrocyte GSH-Px activity (P < 0.001). GSH-Px was positively correlated with serum E2 levels in both premenopausal (r = 0.26, P = 0.011) and postmenopausal women treated with oestrogen replacement therapy (r = 0.42, P = 0.022). No significant correlations in the female population were found between GSH-Px erythrocyte activity and the other sex steroid hormones examined (r2 < or = 0.10, P > or = 0.45). No statistically significant correlations were found between GSH-Px and E2, progesterone and testosterone in the male population (r2 < or = 0.15, P > or = 0.30). CONCLUSIONS: Our findings support the hypothesis that oestrogens are responsible for the sex-related differences in glutathione peroxidase activity. The hypothesis generated from the present study can be tested directly in experimental models involving specific bone marrow cells by analysis of specific glutathione peroxidase transcriptional changes.

Adult↗
PubMed1993

Effect of low dose of dipyridamole on glyceryl trinitrate tolerance in healthy volunteers.

Tolerance to glyceryl trinitrate (GTN) was developed in healthy volunteers by treatment with GTN patches, 10 mg/24 h. The difference (supine position-erect position) in systolic blood pressure (SBP) observed after application of GTN patches at the first day disappeared after 24-h transdermal administration for 2-4 consecutive days, indicating that tolerance to GTN had developed in the group of 12 healthy volunteers treated with active drug. Increased HR during the first day also disappeared as a sign of tolerance development to GTN. The phosphodiesterase (PDE) inhibitor dipyridamole (Dip) showed no effect on SBP in either the GTN-tolerant group or in the placebo group, and the tolerance to GTN was not reversed. The present study shows that addition of Dip to GTN cannot reverse GTN tolerance. Plasma concentrations of GTN and its two dinitrate metabolites were measured after transdermal administration. Addition of Dip to GTN showed no influence on the pharmacokinetics of the nitrates in healthy volunteers.

Adult↗
PubMed2005

Uterine and vaginal effects of unopposed ultralow-dose transdermal estradiol.

OBJECTIVE: To investigate uterine effects of unopposed ultralow-dose transdermal estradiol administered to postmenopausal women for 2 years. METHODS: Postmenopausal women (n = 417), aged 60-80 years, with a uterus and with bone mineral density that was normal for age (z score >or=-2.0) were randomly assigned to receive unopposed transdermal estradiol (14 microg per day) or identical placebo patch. We evaluated effects on endometrial histology, vaginal bleeding, and vaginal epithelial cell maturation. RESULTS: At baseline, estradiol and placebo groups were similar in age (67 +/- 5 years) and in median baseline serum estradiol level (4.8 pg/mL, interquartile range 2.7, 8.0 pg/mL). In the estradiol group, median estradiol level increased to 8.6 pg/mL, (interquartile range 4.4, 13.9 pg/mL, P < .001). In the estradiol group, focal atypical endometrial hyperplasia developed in 1 woman, and adenosarcoma of the uterus developed in 1 woman. The placebo group had no endometrial hyperplasia. Endometrial proliferation occurred in 8.5% of the estradiol group and in 1.1% of the placebo group (P = .06). Incidence of vaginal bleeding was 12.4% in the estradiol group and 8.6% in the placebo group (P = .3). Vaginal epithelial cells showed greater maturation in the estradiol group than in the placebo group (P < .001) but less than typically observed with standard doses of estrogen. CONCLUSION: During 2 years of treatment with ultralow-dose unopposed estradiol, treatment and placebo groups had similar rates of endometrial hyperplasia, endometrial proliferation, and vaginal bleeding. This therapy apparently causes little or no endometrial stimulation. LEVEL OF EVIDENCE: I.

Administration, Cutaneous↗
PubMed2003

[Cataplasma of traditional Chinese medicine].

The TCM (traditional Chinese medicine) transdermal plaster (also known as "cataplasma") are flexible adhesive patches used for treatment of pain, resulted from arthritis, sprain and bruise, tendovaginitis, lumbar spine protrude, neuralgia, hyperosteogeny ache, abdominal discomfort and metastatic cancer, etc. Since the 1980's, investigators in China have used this modern patch delivery system for herbal drugs and obtained satisfactory results especially from the treatment of various types of pain associated with bone diseases, abdominal discomfort, and tumors, etc. The production of TCM cataplasma was successfully scaled up in early 90's and the commercial product line for an antirheumatic agent was first established in Shanghai by Leiyunshang Group. Thus far, a number of products in the form of TCM cataplasma became commercially available in the market, and clinical investigations with these products indicated that topically applicable herbal preparations, especially in the form of cataplasma, are preferred formulations with respect to the treatment comfort of the patient. Compared to the traditional preparations which utilize rubber and rosin as adhesives, cataplasma is advantageous in that the lipophilic and hydrophilic ingredients of the herbal extracts are solubilized and then "gellified" with the organic polymers, and that the drug matrix containing up to 40%-70% of water serves as a "drug reservoir" that will sustain the quick and continuous release of herbal ingredients over several days across the skin. While there are conventional remedies for palliation of pain and discomfort associated with bone diseases or cancers, administration of oral medicinal herbs combined with topical agents such as TCM cataplasma may significantly alleviate the symptoms and improve their quality of life. This article provides a review on three aspects, which include the process development, characteristics and developmental status of TCM cataplasma, and future development of such a technology.

Administration, Cutaneous↗